Dermatologicals and Drug Formulation Quiz
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Questions and Answers

Which of the following is NOT a factor influencing drug penetration through the skin?

  • Physicochemical properties of the drug
  • The vehicle used for the formulation
  • The color of the medication (correct)
  • The condition of the skin
  • According to the provided content, which of the following topical formulations are mentioned as examples of a specific consistency?

  • Tablets
  • Solutions
  • Capsules
  • Creams (correct)
  • Which of the following is NOT a factor influencing drug release from a topical formulation?

  • Drug solubility in the base
  • Type of emulsion base
  • Drug stability in the base
  • The size of the patient (correct)
  • What is a significant concern for a drug intended for topical use that could potentially lead to a change in consistency?

    <p>All of the above (D)</p> Signup and view all the answers

    What is a key factor to consider when formulating a drug for topical use, specifically related to its absorption into the skin?

    <p>The drug must be soluble in both water and lipids (C)</p> Signup and view all the answers

    Which of the following is NOT a function of dermatologicals?

    <p>Enhance skin cell growth (B)</p> Signup and view all the answers

    What is the fourth state of matter?

    <p>Semi-solid (D)</p> Signup and view all the answers

    Which of the following is an example of a semi-solid?

    <p>Chapstick (D)</p> Signup and view all the answers

    What are excipients?

    <p>Substances added to a formulation to improve stability or enhance delivery (B)</p> Signup and view all the answers

    What is the term for the phenomenon where a semi-solid loses water, leading to separation of its components?

    <p>Syneresis (A)</p> Signup and view all the answers

    Which of the following is NOT a type of semi-solid?

    <p>Solution (B)</p> Signup and view all the answers

    What is bioavailability in relation to dermatologicals?

    <p>The ability of a medication to penetrate the skin and reach its target site (C)</p> Signup and view all the answers

    What is the term for the phenomenon where a semi-solid absorbs water and increases in volume?

    <p>Swelling (A)</p> Signup and view all the answers

    Which of the following is NOT a characteristic of thixotropic flow?

    <p>The fluid's viscosity increases with increased shear rate. (C)</p> Signup and view all the answers

    A paste is an example of which type of flow behavior?

    <p>Plastic (B)</p> Signup and view all the answers

    Which of the following ointment bases is an example of a water-in-oil (W/O) emulsion?

    <p>W/O emulsion bases (A)</p> Signup and view all the answers

    Which of the following is a characteristic of Newtonian flow?

    <p>The fluid exhibits a constant viscosity regardless of the applied stress. (D)</p> Signup and view all the answers

    What is the primary difference between thixotropy and negative thixotropy?

    <p>Thixotropy describes an increase in viscosity with time under shear, while negative thixotropy describes a decrease. (B)</p> Signup and view all the answers

    What is the main advantage of oleaginous bases over other ointment bases?

    <p>They provide greater occlusion and emollient effects. (C)</p> Signup and view all the answers

    Which of these is NOT a defining characteristic of an emulsion?

    <p>It always requires the use of a chemical stabilizer to prevent separation. (B)</p> Signup and view all the answers

    What is the primary advantage of using a multiple emulsion (w/o/w or o/w/o) for drug delivery?

    <p>Delayed action drug release. (C)</p> Signup and view all the answers

    What type of flow behavior is characterized by a decrease in viscosity with increasing shear stress?

    <p>Pseudoplastic flow (D)</p> Signup and view all the answers

    Which of the following statements about the rheology of ointment bases is TRUE?

    <p>Newtonian fluids exhibit a constant viscosity regardless of the applied stress. (D)</p> Signup and view all the answers

    What is the primary factor that determines the rate of drug release from an ointment base?

    <p>The solubility of the drug in the base. (B)</p> Signup and view all the answers

    Which type of emulsion is formed when oil is dispersed as globules in water?

    <p>Oil-in-water(o/w) (B)</p> Signup and view all the answers

    Which of these statements about the consistency of an ointment base is TRUE?

    <p>A good ointment base should be able to withstand significant fluctuations in temperature without altering its physical properties. (B)</p> Signup and view all the answers

    Which of the following is NOT a disadvantage of water-soluble bases used for topical drug delivery?

    <p>Physico-chemically more stable than solid dosage forms (C)</p> Signup and view all the answers

    Which of the following properties is NOT ideal for a topical formulation?

    <p>Gritty (B)</p> Signup and view all the answers

    Which of the following is an advantage of topical drug delivery using water-soluble bases?

    <p>Avoids first-pass metabolism (B)</p> Signup and view all the answers

    Regarding water-soluble bases, what is the most likely reason for a topical drug formulation being described as 'bulky'?

    <p>The base itself is thick and difficult to spread. (D)</p> Signup and view all the answers

    Which of the following is LEAST likely to be treated with a water-soluble base topical formulation?

    <p>Severe burns (B)</p> Signup and view all the answers

    Which of these characteristics aligns with an oleaginous base?

    <p>Possesses a high sensitization index. (B)</p> Signup and view all the answers

    Which of the following is NOT a characteristic of oleaginous bases?

    <p>They can readily absorb water. (D)</p> Signup and view all the answers

    What is a key advantage of water-soluble bases compared to liquid dosage forms of drugs?

    <p>Water-soluble bases are more stable than liquid dosage forms. (C)</p> Signup and view all the answers

    What is the principal reason why applying water-soluble bases with fingers might be problematic?

    <p>It could introduce bacteria into the formulation. (C)</p> Signup and view all the answers

    What is a significant difference between oleaginous bases and absorption bases?

    <p>Absorption bases have a higher capacity to absorb water. (C)</p> Signup and view all the answers

    What is a potential drawback of water-soluble bases, particularly in relation to application on the face?

    <p>They can cause irritation or allergic reactions. (A)</p> Signup and view all the answers

    Which property of oleaginous bases makes them unsuitable for topical drug delivery demanding rapid drug release?

    <p>Their high viscosity (A)</p> Signup and view all the answers

    What is an example of a semisolid base that deviates from the typical oleaginous properties?

    <p>Aquaphor (D)</p> Signup and view all the answers

    Which of the following ingredients is NOT typically used in oleaginous bases?

    <p>Glycerin (A)</p> Signup and view all the answers

    Based on the provided text, which of these characteristics would likely improve drug release from an oleaginous base?

    <p>Reduce the thickness of the base (B)</p> Signup and view all the answers

    Which of the following is a reason why oleaginous bases are considered less cosmetically appealing?

    <p>Their sticky and greasy texture (B)</p> Signup and view all the answers

    What is the primary route of drug penetration into the skin from a topical formulation?

    <p>Transdermal pathway (C)</p> Signup and view all the answers

    Which of these routes is considered LESS efficient for drug delivery due to its limited surface area?

    <p>Transappendageal route (D)</p> Signup and view all the answers

    Based on the provided text, which drug type is most likely to penetrate the skin effectively through the transcellular pathway?

    <p>Lipophilic drugs (C)</p> Signup and view all the answers

    The epidermis layer is said to be about 0.05 mm thick in the eyelids and 1.5 mm thick on the palms and soles. What does this indicate about drug penetration?

    <p>Drug penetration is faster in the eyelids due to thinner skin. (A)</p> Signup and view all the answers

    Based on the text, which of the following is true for the Transdermal route?

    <p>It allows for a systemic effect. (D)</p> Signup and view all the answers

    What is one advantage of transdermal drug delivery (TDD) compared to oral drug delivery?

    <p>TDD avoids the first-pass effect, which can significantly reduce drug bioavailability. (D)</p> Signup and view all the answers

    What is the primary mechanism of drug delivery in transdermal drug delivery (TDD)?

    <p>Passive diffusion through the skin. (D)</p> Signup and view all the answers

    Based on the provided information, what was the first commercially available prescription patch approved by the FDA?

    <p>A patch for delivering scopolamine for motion sickness. (D)</p> Signup and view all the answers

    Which of the following is NOT an advantage of transdermal drug delivery (TDD) mentioned in the text?

    <p>TDD can be readily adjusted to suit the needs of the individual patient. (C)</p> Signup and view all the answers

    What is one reason why transdermal drug delivery (TDD) might be preferred over oral drug delivery?

    <p>TDD avoids the potential for drug interactions with food. (C)</p> Signup and view all the answers

    What is the rate-limiting step for transdermal drug delivery?

    <p>Diffusion through the stratum corneum (B)</p> Signup and view all the answers

    Which of the following is NOT a major layer of the skin?

    <p>Epidermis (B)</p> Signup and view all the answers

    Which transport process involves the movement of a drug through the cells of the skin?

    <p>Transcellular (A)</p> Signup and view all the answers

    Which of the following components of a transdermal patch is responsible for controlling the rate of drug release?

    <p>Rate-controlling membrane (D)</p> Signup and view all the answers

    How does increasing the molecular weight of a drug typically affect its penetration through the skin?

    <p>Decreases penetration (C)</p> Signup and view all the answers

    What is the ideal LogP range for a drug to optimize transdermal absorption?

    <p>1 &lt; LogP &lt; 3 (D)</p> Signup and view all the answers

    Which of the following biological factors can negatively affect drug absorption from a transdermal patch?

    <p>Skin disease (D)</p> Signup and view all the answers

    Which of these statements is TRUE regarding transdermal patches that can theoretically be cut?

    <p>They are designed to release a consistent dose per unit area (B)</p> Signup and view all the answers

    What is the ideal Log P range for a drug intended for transdermal delivery?

    <p>1 - 3 (B)</p> Signup and view all the answers

    Which of these factors directly influence the rate-limiting step of transdermal drug absorption?

    <p>Ability of the drug to cross the stratum corneum (B)</p> Signup and view all the answers

    What is the primary component of the stratum corneum, making up approximately 40% of its composition?

    <p>Keratin (D)</p> Signup and view all the answers

    Which of these attributes is NOT a key factor influencing the effectiveness of a transdermal drug delivery system (TDD) formulation?

    <p>Drug's ability to form a gel when applied to the skin (A)</p> Signup and view all the answers

    Which of these factors can directly impact the permeability of the skin, affecting transdermal absorption?

    <p>Skin hydration (A)</p> Signup and view all the answers

    What is the ideal molecular weight range for drugs intended for transdermal delivery?

    <p>100 - 800 (B)</p> Signup and view all the answers

    What is the primary reason why hydration of the skin significantly affects transdermal drug absorption?

    <p>Hydration increases the permeability of the stratum corneum, allowing for easier passage of the drug. (C)</p> Signup and view all the answers

    What is the significance of the stratum corneum being composed of keratinized tissue in the context of transdermal drug delivery?

    <p>Keratinized tissue helps to form a protective barrier against external substances, slowing down drug absorption. (D)</p> Signup and view all the answers

    Which of the following are advantages of topical drug delivery?

    <p>Reduced dosing frequency (A), Self-administration (B), Greater patient compliance (C), More predictable and extended duration of activity (D)</p> Signup and view all the answers

    What is a key disadvantage of topical drug delivery?

    <p>Requires high drug load/concentration, limiting suitability for delivering large amounts of drug systemically (A), Most drugs have poor penetration through the skin and may fail to reach systemic circulation (B), Onset of action can be delayed, taking 24-48 hours or more (C), Potential for local irritation and poor adhesion (D)</p> Signup and view all the answers

    What is the primary function of the epidermis, one of the three layers of human skin?

    <p>Provides a protective barrier against external factors (D)</p> Signup and view all the answers

    Which of these factors is NOT a potential disadvantage of topical drug delivery compared to other routes of administration?

    <p>Faster onset of action compared to oral administration (B)</p> Signup and view all the answers

    What are the potential effects of drugs applied topically, based on the information provided?

    <p>All of the above (D)</p> Signup and view all the answers

    Why is it important to consider the drug load or concentration when formulating a topical drug?

    <p>All of the above (D)</p> Signup and view all the answers

    Which of these factors is LEAST likely to influence the penetration of a drug through the skin?

    <p>The individual's dietary habits (C)</p> Signup and view all the answers

    What is the main reason why topical drug delivery, despite potential disadvantages, is an important option for drug administration?

    <p>It allows for targeted drug delivery to the skin, potentially minimizing systemic side effects (A)</p> Signup and view all the answers

    Which of these is NOT an advantage of respiratory drug delivery for local effect?

    <p>Increased risk of systemic side effects (C)</p> Signup and view all the answers

    Which of these factors can affect drug deposition in the lower respiratory tract?

    <p>All of the above (D)</p> Signup and view all the answers

    What is a potential disadvantage of respiratory drug delivery for local effect?

    <p>All of the above (D)</p> Signup and view all the answers

    Which of these factors is NOT a reason why inhaled drugs are preferred over oral drugs?

    <p>Provides slower drug delivery (D)</p> Signup and view all the answers

    What is the primary reason inhaled drugs can go directly to the lungs, minimizing side effects?

    <p>Particles are small enough to reach the alveoli (B)</p> Signup and view all the answers

    Which of these is NOT a structure found in the lower respiratory tract?

    <p>Pharynx (A)</p> Signup and view all the answers

    Why is rapid onset of action a potential advantage of inhaled drug delivery?

    <p>All of the above (D)</p> Signup and view all the answers

    Which of these is a potential concern when considering the use of inhaled drugs?

    <p>All of the above (D)</p> Signup and view all the answers

    Which of the following is NOT a factor that influences drug deposition in the lung?

    <p>The patient's previous medication history (C)</p> Signup and view all the answers

    What is the primary reason why a particle with an aerodynamic diameter of 5 microns is considered suitable for reaching the lower respiratory tract?

    <p>It has a settling velocity similar to a 5-micron spherical particle with a density of 1 g/cm3, facilitating its transport to the lower respiratory tract. (B)</p> Signup and view all the answers

    Which of the following particle sizes is most suitable for targeting the terminal airways and alveolar region for drug delivery?

    <p>0.8 to 3 µm (B)</p> Signup and view all the answers

    Which of the following statements accurately reflects the relationship between the aerodynamic diameter and the Stokes diameter of a particle?

    <p>The Stokes diameter is a measure of the particle's density, while the aerodynamic diameter reflects its settling velocity. (A)</p> Signup and view all the answers

    Which of the following factors is NOT specifically mentioned as influencing the settling velocity of a particle in the provided content?

    <p>Particle shape (A)</p> Signup and view all the answers

    According to the information provided, which particle size range is most likely to be affected by 'slip factors' in calculating settling velocity?

    <blockquote> <p>10 µm (D)</p> </blockquote> Signup and view all the answers

    The equation for settling velocity is adapted from Stoke's Law, which describes the motion of viscous fluids. What does this suggest about the importance of the fluid medium in drug delivery to the lungs?

    <p>The viscosity of the air in the lungs significantly affects how particles settle and deposit in the respiratory tract. (A)</p> Signup and view all the answers

    In the context of pulmonary drug delivery, what is the significance of the Stokes diameter?

    <p>It helps predict the rate at which a particle will settle in a fluid medium, specifically air in the lungs. (B)</p> Signup and view all the answers

    What is the threshold dose for mortality according to radiation effects?

    <p>150 rem (A)</p> Signup and view all the answers

    Which radionuclide is most appropriate for imaging the thyroid gland?

    <p>123I (B)</p> Signup and view all the answers

    What type of radiation is primarily utilized in therapeutic effects?

    <p>Beta radiation (A)</p> Signup and view all the answers

    What is the duration of the half-life for the radionuclide 131I?

    <p>8 days (A)</p> Signup and view all the answers

    Which dose category indicates a maximum likelihood of 100% mortality even with the best treatment?

    <p>800 rem (B)</p> Signup and view all the answers

    Which of these effects typically occurs at a threshold dose of 100 rem?

    <p>Vomiting (A)</p> Signup and view all the answers

    Which radionuclide is better suited for diagnostic imaging?

    <p>123I (B)</p> Signup and view all the answers

    What is the characteristic of the decay product that is ideal for both diagnostic imaging and therapeutic effects?

    <p>Minimal and short-lived activity (D)</p> Signup and view all the answers

    What is the term for the amount of time it takes for one-half of the radioactive atoms to disintegrate or decay?

    <p>Half-life (B)</p> Signup and view all the answers

    If you get 125I on your shoes, what is the main concern based on its half-life?

    <p>It will take a long time to decay, posing a potential radiation hazard for a significant period. (A)</p> Signup and view all the answers

    What is the main goal when using radionuclide conjugation in therapy?

    <p>To prevent pharmacodynamic or toxicologic effects on organs (A)</p> Signup and view all the answers

    What is the primary advantage of using a film badge, ring dosimeter, or pocket dosimeter?

    <p>They provide accurate measurements of the amount of radiation absorbed by the body. (C)</p> Signup and view all the answers

    What is the main unit used in nuclear pharmacy for therapeutic radioactive doses?

    <p>Gray (Gy) (A)</p> Signup and view all the answers

    How does the effective half-life of a radiopharmaceutical relate to its physical and biological half-lives?

    <p>It is a combination of the physical and biological half-lives (C)</p> Signup and view all the answers

    Which radioisotope is most commonly used for cancer diagnosis in imaging?

    <p>Technetium 99 (B)</p> Signup and view all the answers

    What does the acronym ALARA stand for?

    <p>As Low As Reasonably Achievable (B)</p> Signup and view all the answers

    What components are typically found in a radiopharmaceutical kit?

    <p>Sterile ingredients and a radioactive isotope (C)</p> Signup and view all the answers

    What is the primary side effect associated with targeted radioactive monoclonal antibodies?

    <p>Myelosuppression (A)</p> Signup and view all the answers

    What advantage does radioimmunotherapy offer compared to traditional chemotherapy?

    <p>It combines radiation with immune-mediated cellular toxicity (C)</p> Signup and view all the answers

    Which of the following is a characteristic of radionuclides used for preferential uptake in specific organs?

    <p>They show preferential uptake like iodine in the thyroid (B)</p> Signup and view all the answers

    What is a rare risk associated with radiopharmaceuticals?

    <p>Adverse reactions (D)</p> Signup and view all the answers

    What is true about alpha radiation?

    <p>It cannot penetrate the outer layers of skin or paper. (A)</p> Signup and view all the answers

    Which of the following accurately distinguishes between effective half-life and physical half-life?

    <p>Effective half-life considers biological elimination, while physical half-life does not. (A)</p> Signup and view all the answers

    Which organization is NOT involved in the regulation of radiopharmaceuticals for human use?

    <p>World Health Organization (WHO) (A)</p> Signup and view all the answers

    What is the primary characteristic of gamma radiation?

    <p>Short wavelength with high penetrating ability. (C)</p> Signup and view all the answers

    What was one of the major contributions of Wilhelm Conrad Roentgen to medical imaging?

    <p>Discovery of x-rays. (D)</p> Signup and view all the answers

    Which type of radiation is considered to have medium penetrating ability?

    <p>Beta (C)</p> Signup and view all the answers

    How does radioactivity relate to the stability of nuclides?

    <p>Radioactivity is the process of emitting energy to achieve stability. (D)</p> Signup and view all the answers

    What role do radiopharmaceuticals play in medicine?

    <p>They are used for imaging and therapeutic procedures. (D)</p> Signup and view all the answers

    What is the primary purpose of placing a syringe filled with radioactive material in a properly shielded container?

    <p>To prevent contamination and spills (C)</p> Signup and view all the answers

    Which equation is used to calculate the remaining activity of a radionuclide over time?

    <p>N = N0e^(-λt) (C)</p> Signup and view all the answers

    If the disintegration constant of a radioisotope is 0.02496 days$^{-1}$, what is its half-life?

    <p>28.0 days (D)</p> Signup and view all the answers

    How much of a 100 mCi radioisotope remains after 6 days if the remaining quantity is 75 mCi?

    <p>A reduction of 25 mCi represents a decay (B)</p> Signup and view all the answers

    When calculating the activity of a sample of 131I after 20 days with an initial activity of 30 µCi and a half-life of 8.08 days, what is the correct approach?

    <p>Utilize the equation N = N0e^{-λt} (A)</p> Signup and view all the answers

    Which statement best explains the significance of the decay constant in radioactive material calculations?

    <p>It impacts the speed at which the material disintegrates (C)</p> Signup and view all the answers

    What should be done before dispensing radioactive solutions from a nuclear pharmacy?

    <p>Confirm that it is in a properly shielded container (D)</p> Signup and view all the answers

    If a sample of sodium phosphate P32 is to provide an activity of 250 μCi after 10 days and has a half-life of 14.3 days, what is the correct administration volume assuming an initial activity of 500 μCi/ml?

    <p>1 ml (D)</p> Signup and view all the answers

    Which of these are acceptable solvents or vehicles for parenteral formulations?

    <p>Propylene glycol (A), Water for injection (B), Glycerin (D)</p> Signup and view all the answers

    Parenteral articles must be isotonic.

    <p>True (A)</p> Signup and view all the answers

    Why is the use of colorants as additives strictly prohibited in parenteral formulations?

    <p>Colorants can increase the risk of particulate matter and allergic reactions, making them unsuitable for parenteral formulations.</p> Signup and view all the answers

    __________ are substances that are used to protect cells from damage during freezing and thawing.

    <p>Cryoprotectants</p> Signup and view all the answers

    Match the parenteral routes of administration with their respective onset times:

    <p>Intravenous (IV) = Fastest Intramuscular (IM) = Intermediate Subcutaneous (SC) = Slowest</p> Signup and view all the answers

    Once a pharmaceutical company is approved to use a specific container for a drug, they can change it without FDA approval if the medication is on back-order.

    <p>False (B)</p> Signup and view all the answers

    Which of the following are advantages of using the parenteral route of drug administration?

    <p>Rapid onset of action (A), Bypasses physiological barriers (B), Predictable bioavailability (C), Can be used for drugs ineffective by other routes (D), All of the above (E)</p> Signup and view all the answers

    What type of container is light, resistant to impact, and does not have problems with vacuums when withdrawing fluid?

    <p>PVC Bags (B)</p> Signup and view all the answers

    Sterilization using ______ requires temperatures of at least 160°C for more than 2 hours.

    <p>dry heat</p> Signup and view all the answers

    The parenteral route is preferred by patients due to its ease of administration.

    <p>False (B)</p> Signup and view all the answers

    Match the following sterilization methods with their appropriate descriptions:

    <p>Steam Sterilization = Suitable for preparations and materials that can withstand high temperatures and are not sensitive to moisture Dry Heat Sterilization = Effective for materials that can withstand high temperatures and do not need to be moistened Gas Sterilization = Used for heat-sensitive materials and can penetrate porous materials Radiation Sterilization = Kills microorganisms using ionizing radiation and is well-suited for heat-sensitive items</p> Signup and view all the answers

    What are two major disadvantages of the parenteral route of administration?

    <p>Expensive and potential introduction of micro-organisms/toxins</p> Signup and view all the answers

    The parenteral route can be used for drugs that are ______ via other routes.

    <p>ineffective</p> Signup and view all the answers

    Match the following parenteral terms with their definitions:

    <p>Sterile = Free from living microorganisms Bioavailability = The extent to which a drug is absorbed and reaches the systemic circulation Extravasation = Leakage of a drug from a vein into surrounding tissues Hemolysis = Rupture of red blood cells Thrombosis = Formation of a blood clot in a vein or artery Precipitation = Formation of a solid from a solution Osmolarity = The concentration of dissolved particles in a solution</p> Signup and view all the answers

    Which of the following factors are important for pharmaceutical scientists to consider when formulating parenteral drugs?

    <p>Drug solubility (A), Partition coefficient (B), Ionization (C), Osmolarity (D), Sterilization (E), Excipient concentration (F), All of the above (G)</p> Signup and view all the answers

    Large volume parenterals are typically administered via IV infusion to maintain body fluids and electrolytes.

    <p>True (A)</p> Signup and view all the answers

    What are two examples of small volume parenterals?

    <p>Heparin sodium and insulin</p> Signup and view all the answers

    What is the typical volume range for IV solutions?

    <p>100 ml to 1 L (C)</p> Signup and view all the answers

    Dialysis solutions require the same level of sterility as IV solutions.

    <p>True (A)</p> Signup and view all the answers

    What is the purpose of irrigation solutions?

    <p>To bathe, wash wounds or surgical incisions or body tissues.</p> Signup and view all the answers

    Powders for injections are ______ substances that are usually dissolved or suspended in a sterile diluent.

    <p>dry solid, sterile</p> Signup and view all the answers

    Match the following routes of administration with their primary characteristics:

    <p>IV = Most rapid onset, complete bioavailability, bolus dosing or infusion IM = Easier administration than IV, slower onset but prolonged action Intradermal = Volumes up to 0.2 mL, absorption is slow Subcutaneous (SC) = Slower onset than IM, but fairly rapid and predictable absorption</p> Signup and view all the answers

    What is the primary function of a buffering agent in parenterals?

    <p>Maintain optimal pH for stability and solubility (B)</p> Signup and view all the answers

    Co-solvents are used to increase drug solubility by a factor of approximately 100 times.

    <p>False (B)</p> Signup and view all the answers

    What is the main purpose of using surfactants in parenteral formulations?

    <p>Surfactants are used to improve drug solubility and aid in suspension formation.</p> Signup and view all the answers

    _________ agents, such as EDTA or citric acid, are used to remove trace elements that can catalyze oxidative degradation of drugs.

    <p>Chelating</p> Signup and view all the answers

    Match the following buffer systems with their corresponding pKa values:

    <p>Phosphoric acid = 2.1, 7.3, 12.3 Citric acid = 3.1, 4.8, 6.4 Lactic acid = 3.9 Glutamic acid = 2.11, 4.1, 9.5 Acetic acid = 4.8</p> Signup and view all the answers

    Which of the following is NOT a common method used to modify the formula of a parenteral drug to improve its properties?

    <p>Addition of a preservative (B)</p> Signup and view all the answers

    Emulsions are frequently used in parenteral formulations to solubilize drugs that are soluble only in organic solvents.

    <p>True (A)</p> Signup and view all the answers

    Why is it important to consider the blood flow at the injection site when administering parenteral drugs?

    <p>Blood flow influences the rate of drug absorption and distribution, affecting the onset and duration of drug action.</p> Signup and view all the answers

    Which of the following is NOT a disadvantage of ethylene oxide sterilization?

    <p>Potential for product damage (C)</p> Signup and view all the answers

    Filter sterilization using a 0.22 micron filter or less is suitable for sterilizing suspensions.

    <p>False (B)</p> Signup and view all the answers

    What is the primary advantage of filter sterilization for biologics?

    <p>Filter sterilization is the preferred method for sterilizing delicate proteins and other biomolecules as it minimizes the risk of damage compared to other methods like heat sterilization.</p> Signup and view all the answers

    The preferred method for sterilizing delicate proteins and other biomolecules, using specialized filters with a pore size of ______ or less, is called ______ sterilization.

    <p>0.22 micron, filter</p> Signup and view all the answers

    Match the sterilization methods to their respective advantages:

    <p>Heat Sterilization = Effective for heat-stable preparations, powders, and oils, but can damage heat-sensitive products. Filter Sterilization = Gentle method suitable for thermolabile and moisture-sensitive substances, however, may not remove all microbes. Gas Sterilization (Ethylene Oxide) = Effective against all microbes, but can be slow, expensive and pose safety hazards due to flammability and toxicity Radiation Sterilization = Suitable for sterilizing articles not sterilizable by other methods, such as syringes and catheters, but can cause destruction of some products.</p> Signup and view all the answers

    Flashcards

    Syneresis

    The separation of liquid from a gel-like substance, typically seen in semi-solids.

    Swelling

    The process in which a material increases in volume when it absorbs moisture or solvent.

    Imbibition

    The absorption of liquid by a solid or gel, leading to swelling and changes in properties.

    Semi-Solid

    A state of matter that holds its shape when not disturbed, found in pharmaceuticals and cosmetics.

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    Function of Dermatologicals

    Products that protect skin, enhance hydration, and serve as medication transport vehicles.

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    Types of Semi-Solids

    Categories of semi-solids include creams, gels, ointments, and pastes, often containing active ingredients.

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    Bioavailability

    The degree to which a drug or substance is absorbed into the bloodstream from the application site.

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    Signs of Physical Instability

    Indicators that a semi-solid formulation has changed, potentially affecting its efficacy and safety.

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    Change in consistency

    Alteration in the texture or appearance of a formulation, such as ointments or creams.

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    Types of formulations

    Includes ointments, creams, lotions, and pastes used for topical application.

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    Drug penetration factors

    Effectiveness of a drug depends on properties of the drug and the vehicle used, as well as skin condition.

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    Physical deterioration

    Changes like separation or discoloration due to instability or contamination in formulations.

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    Aqueous and lipid solubility

    Need for drugs to dissolve in both water and fats for effective skin absorption.

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    Non-Newtonian Flow

    A type of fluid whose viscosity changes under stress, unlike Newtonian fluids.

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    Plastic Flow

    No flow occurs until a specific shear stress is applied; exemplified by ointments.

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    Thixotropy

    A time-dependent shear-thinning property where a viscous substance becomes less viscous when agitated.

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    Negative Thixotropy

    A phenomenon where a fluid becomes more viscous with prolonged shear or agitation.

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    Ointment Bases

    Semisolid preparations classified by their composition, used for topical application.

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    Water-soluble bases

    Bases that dissolve in water and may contain active drugs for topical application.

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    Advantages of water-soluble bases

    Benefits include site-specific action and avoiding first-pass metabolism.

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    Disadvantages of water-soluble bases

    Drawbacks include possible staining and being bulky to handle.

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    Ideal properties of ointments

    Ointments should be smooth, non-dehydrating, and easy to spread.

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    First-pass metabolism

    The process where a drug's effectiveness is reduced after passing through the liver before entering circulation.

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    Examples of conditions treated with ointments

    Ointments can treat minor skin infections, burns, and rashes.

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    Bulkiness issue

    The physical size of water-soluble bases can make them inconvenient to use.

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    Stability of formulations

    Water-soluble bases may be less stable than solid forms like tablets.

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    Rancidity of Base

    Decomposition of a base causing off-flavors or smells due to oxidation.

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    Oleaginous Bases

    Ointment bases that are oily and provide occlusion and emollient effects.

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    Types of Emulsions

    Mixes of immiscible liquids, like oil and water; can be o/w or w/o.

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    Microemulsions

    Stable systems formed by mixing oil and water in specific ratios, appears clear.

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    Pseudoplastic Flow

    Type of flow where viscosity decreases with increased shear stress, common in creams.

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    Dilatant Flow

    A flow type where viscosity increases with applied stress, making it thicker.

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    Occultation

    The ability of a base to create a barrier on the skin to prevent moisture loss.

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    Consistency of Creams

    Ability of cream to maintain its properties under temperature changes.

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    Properties of Oleaginous Bases

    Characteristics include being hydrophobic, difficult to spread, and poor drug release efficacy.

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    Absorption Bases

    Bases that can absorb water and have characteristics between oleaginous and water-in-oil bases.

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    Aquaphor

    A specific absorption base containing 41% petrolatum, capable of absorbing up to 3 times its weight in water.

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    W/O Bases

    Water-in-oil emulsion bases that contain a greater proportion of oil, giving them a greasy feel.

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    Semisolid Flow Characteristics

    Semisolids exhibit plastic flow, becoming more viscous with constant application.

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    Viscosity in Skin Products

    Viscosity refers to the resistance of a liquid to flow, impacting application ease and drug release.

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    Low Sensitization Index

    Indicates minimal likelihood of causing irritation or allergic reactions in topical applications.

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    Functions of the Skin

    Protects the body, regulates temperature, and contains internal organs.

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    Transdermal Drug Delivery (TDD)

    A method delivering medication through the skin for systemic effect.

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    Advantages of TDD

    Rapid drug effect termination and avoids first pass metabolism, enhancing absorption.

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    First Commercial TDD Patch

    The first patch, Scopalmine for motion sickness, approved in 1979.

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    Drug Absorption Barriers

    Factors affecting drug absorption include pH, interactions, and irritation in the GI tract.

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    Layers of the Skin

    The major layers include the epidermis, dermis, and subcutaneous layer.

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    Rate Limiting Step

    The slowest step in the process that limits the overall rate of transdermal drug delivery.

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    Transport Processes

    Methods of drug movement: transcellular, intercellular, and transappendageal.

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    Transdermal Patch Components

    Roles include drug reservoir, adhesive, and backing layer.

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    Dissolution vs Diffusion

    Dissolution controlled implants release drug via solubility; diffusion controlled releases via concentration gradient.

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    LogP Ratio

    A measure of a drug's polarity; ideal values determine absorption efficiency.

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    Percutaneous Absorption

    The process of drug absorption through the skin layers.

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    Cuttable Patches

    Some patches can be cut, others can't; generally, hydrogel patches can be cut whereas matrix patches cannot.

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    Stratum Corneum Effect

    Refers to the impact of substances on the outer skin layer, like moisturizers and salicylic acid.

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    Transappendageal Route

    Drug transport route through skin's appendages like hair follicles and sweat glands.

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    Transepidermal Pathway

    Limited route for drug transport through skin cells, mainly for lipophilic drugs.

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    Epidermis Thickness

    The thickness of the epidermis varies from 0.05 mm on eyelids to 1.5 mm on palms and soles.

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    Subcutaneous Tissues

    Layer beneath the skin that contributes to systemic drug effects requiring deeper penetration.

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    Intercellular

    Relating to the space between cells, important for drug placement.

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    Log P

    A measure indicating the lipophilicity or hydrophilicity of drugs; ideal range is 1-3 for TDD.

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    Stratum Corneum

    The outermost layer of skin, acts as a barrier for drug penetration.

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    Attributes of TDD Formulation

    Key features include drug concentration, surface area, solubility, and molecular weight.

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    Physicochemical Factors

    Factors affecting drug absorption include hydration, temperature, and molecular weight.

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    Drug Concentration

    The amount of drug present in a patch, influencing absorption rate.

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    Non-invasive

    A method that does not require breaking the skin or causing physical damage.

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    Drug Penetration

    The ability of a drug to pass through the skin layers to reach systemic circulation.

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    Extended Duration of Activity

    A property allowing drugs to provide effects over a longer period.

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    Patient Compliance

    The degree to which patients follow prescribed treatment regimens.

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    Onset Time

    The time it takes for a drug to start showing effects after administration.

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    Local Irritation

    Skin discomfort or reaction at the site of drug application.

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    High Drug Load

    A requirement for a significant amount of drug to achieve desired effects in systemic circulation.

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    Human Skin Layers

    The three main layers: epidermis, dermis, and subcutaneous tissue.

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    Mean Aerodynamic Diameter (MAD)

    Size of a sphere with the same settling velocity as a particle.

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    Settling Velocity

    Rate at which particles settle in a fluid, influenced by size and density.

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    Stokes Diameter

    Diameter of a sphere matching a particle's density and settling speed.

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    Aerosol Work Region Size

    Sizes of aerosol particles suited for specific regions of the respiratory tract.

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    Particle Size for Nasal Spray

    Ideal size for effective nasal delivery is greater than 10 µm.

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    Particle Size for Bronchoactive Drugs

    Best inhaled particle size is 2 to 5 µm for deep lung penetration.

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    Terminal Airways Size

    Ideal particle size for delivering drugs to terminal airways is 0.8 to 3 µm.

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    Factors Affecting Drug Deposition

    Includes physicochemical properties, anatomy, and delivery device.

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    Pulmonary Drug Delivery

    Administration of drugs via inhalation to achieve local or systemic effects.

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    MDI vs DPI

    MDI (Metered Dose Inhaler) uses propellant; DPI (Dry Powder Inhaler) relies on inhalation.

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    Benefits of Inhaled Drugs

    Rapid action, reduced side effects, bypasses GI tract.

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    Local Effect Advantages

    Drugs delivered to the action site, lower doses needed, rapid onset.

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    Local Effect Disadvantages

    Difficult dose estimation, technique guidance needed, mucus can hinder delivery.

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    Mucociliary Clearance

    The body's mechanism to remove mucus and debris from the lungs.

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    Respiratory Tract Anatomy

    Includes trachea, bronchi, bronchioles, and alveoli for air passage and gas exchange.

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    Visit to the Lungs

    Inhaled drugs go directly to lungs, minimizing systemic absorption.

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    Radiopharmaceutical

    An agent used for diagnostic or therapeutic procedures involving radiation.

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    Types of Radiation

    Includes alpha, beta, and gamma radiation, each with different penetrating abilities.

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    Alpha Radiation

    Radiation that cannot penetrate skin but can damage nearby tissues.

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    Beta Radiation

    Radiation with medium penetrability, useful therapeutically.

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    Gamma Radiation

    Highly penetrating radiation, often used in medical imaging.

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    Effective Half-Life

    The time it takes for the activity of a radioactive substance to reduce to half, accounting for biological processes.

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    Physical Half-Life

    Time required for half of a radioactive material to decay.

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    Biological Half-Life

    Time taken for the body to eliminate half of a substance through biological means.

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    Half-life

    The time it takes for half of radioactive atoms to decay.

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    Curie (Ci)

    A unit measuring radioactivity; 1 Ci equals 3.7 x 10^10 disintegrations per second.

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    Becquerel (Bq)

    The SI unit of radioactivity; 1 Bq equals 1 disintegration per second.

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    Gray (Gy)

    A unit measuring absorbed radiation dose in tissue.

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    ALARA Principle

    'As Low As Reasonably Achievable' to minimize radiation exposure.

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    Conjugate in Radiopharmacy

    Delivery method for radionuclide to targets or increase stability.

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    Technetium 99

    Most commonly used radioisotope for cancer diagnosis.

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    Radioimmunotherapy

    Combines radiation and immune response for cancer treatment.

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    Radiopharmaceutical Kit

    Prepacked set of ingredients for compound production in radiopharmacy.

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    Myelosuppression

    Main side effect of radioimmunotherapy, often reversible.

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    Curie

    A unit that measures radioactivity or activity of a radioactive substance.

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    Becquerel

    The SI unit that measures the activity of a radioactive material, equal to one disintegration per second.

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    LD50/60

    The lethal dose of radiation that kills 50% of a population in 60 days, assuming minimal care.

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    Dose-Related Effects

    Biological effects that increase in severity with the amount of radiation exposure.

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    Radionuclide

    A radioactive isotope used in medical applications for imaging or therapy.

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    Radionuclide Half-Life

    The time required for a radionuclide to decay to 50% of its original activity.

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    Decay Constant (λ)

    The constant that represents the rate of decay for a radionuclide in the decay equation.

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    Remaining Activity Formula

    Formula N=Noe-λt calculates the activity remaining of a radionuclide.

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    Disintegration Constant

    A measure of the probability of decay of a radionuclide per unit time.

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    Counseling Point in Nuclear Pharmacy

    Ensure safe handling of radioactive materials in properly shielded containers to prevent contamination.

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    Parenteral Definition

    Preparations intended for injection through skin or tissue, bypassing the GI tract.

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    Pyrogens

    Substances that induce fever, must be avoided in parenteral preparations.

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    Sterile Requirements

    Parenteral drugs must be isotonic, sterile, and free from particulates.

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    Lyophilization

    A freeze-drying process used to preserve drugs by removing water content.

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    Cryoprotectants

    Substances used to protect biological samples during freezing.

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    Physiological Barriers

    Natural obstacles that drugs face during absorption, like skin and liver.

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    Advantages of Parenteral Routes

    Benefits include rapid onset, predictable bioavailability, and usability in unconscious patients.

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    Disadvantages of Parenteral Routes

    Drawbacks include cost, sterility requirements, and patient discomfort.

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    Drug Solubility

    The ability of a drug to dissolve, impacting absorption and formulation.

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    Large Volume Parenterals

    IV solutions used for fluid and electrolyte replenishment or nutrition.

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    Small Volume Parenterals

    Vials or syringes of drugs, typically 2 to 30 ml, for specific therapies.

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    Thrombosis

    The formation of blood clots in blood vessels, a risk from parenteral routes.

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    Excipient Concentration

    The amount of inactive substances in a drug formulation; can influence stability.

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    Filtration

    A method that removes most bacteria and particles but allows viruses to pass.

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    Gas Sterilization

    Uses ethylene oxide to disrupt DNA of microorganisms; suitable for heat-sensitive materials.

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    Radiation Sterilization

    Used for items not sterilizable by other methods; can affect product structure.

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    In-Process Sterilization

    Maintaining sterility from the initial stages of production; may be costly.

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    Filter Sterilization for Biologics

    Preferred sterilization method for delicate proteins; ensures product safety.

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    Buffering Agents

    Substances added to maintain pH for solubility and stability in parenterals.

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    Co-solvent

    Substances that improve solubility and prevent hydrolysis in drug formulations.

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    Surfactants

    Agents that improve solubility and help in the suspension of drugs.

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    Prodrug

    A modified drug form that alters solubility or action duration.

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    Chelating Agents

    Substances that remove trace elements to prevent oxidative degeneration.

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    Route of Injection

    The pathway through which drugs enter the body, greatly influencing absorption.

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    Adipose Tissue Effect

    Fatty tissues influence plasma drug levels post-injection.

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    Container Materials

    Materials of containers that can interact with drug solutions.

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    Aseptic Technique

    Procedures to prevent contamination in sterile environments.

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    Steam Sterilization

    Method using steam at high temperature for sterilizing preparations.

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    Dry Heat Sterilization

    Sterilization method using hot air at high temperatures.

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    Environmental Controls

    Measures to maintain a sterile manufacturing environment.

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    Container Approval

    Pharmaceuticals must retain container type after FDA approval.

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    Dialysis Solutions

    Large volume sterile solutions used in dialysis, typically between 2.5 L to 5 L.

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    Irrigation Solutions

    Used to wash or bathe tissues, typically not sterile for wound use.

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    Powders for Injections

    Dry, sterile solids needing a diluent to create solutions or suspensions.

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    Freeze-dried (lyophilized) Drugs

    Drugs preserved by freezing and removing water to create a dry powder.

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    IV Administration

    Intravenous method allowing rapid onset and complete drug bioavailability.

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    IM Administration

    Intramuscular method for slower drug absorption but longer action.

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    Subcutaneous Administration

    Injection method under the skin allowing steady absorption.

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    Intradermal Administration

    Injection method into the skin, used for diagnostic tests.

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    Study Notes

    Semisolid Dosage Forms

    • Semisolid dosage forms include ointments, creams, gels, and pastes
    • Distinguishing features of each form vary (e.g., ointments are viscous, creams are water-soluble)
    • Knowledge of the characteristics of each form is crucial for selecting the appropriate product for a patient's needs.
    • Ointment bases come in five types, each with unique qualities.
    • Patients' specific needs dictate the chosen base
    • Emulsions (internal and external phases): Understanding emulsion types aids component/chemical additions.
    • Semisolid dosage forms include ointments, creams, gels, and pastes. These forms have unique characteristics and properties that influence drug delivery and patient care.

    Objectives

    • Limitations of suppository bases and selection based on drug solubility
    • Ointment compounding methods (geometric dilution)
    • Suppository base types (e.g., polymorphs, fridge storage, alter melting points)
    • Methods to alter melting points of suppositories
    • Knowledge of BUD (beyond-use date).
    • Understanding transdermal, other semi-solid, and pulmonary drug delivery.
    • Radiopharmaceuticals and their kinetics/practice concerns (e.g., type and amount of radioactivity, half-life, safety precautions, etc.)
    • Types of semi-solids and skin penetration mechanisms.
    • Understanding the principles of transdermal drug delivery.

    Semi-Solids

    • 4th state of matter: similar to a 4th state of matter, similar to whip cream
    • Holds shape, undisturbed
    • Pharmaceutical cosmetics: whip cream to chapstick
    • Skin penetration mechanisms (intercellular, transcellular, intracellular, transappendageal, transfollicular)
    • Methods of skin penetration: Intercellular, transcellular, intracellular, transappendageal, and transfollicular

    Function of Dermatologicals

    • Protect injured areas
    • Hydrate skin (emollients)
    • Medication delivery vehicle (local or systemic)
    • Prophylactic (e.g., Neosporin).
    • Topical formulations and transdermal patches
    • Protection
    • Hydration
    • Delivery vehicle
    • Prophylactic types

    Types of Semi-Solids

    • Creams
    • Gels
    • Ointments
    • Pastes
    • Contain active ingredients and excipients (e.g., emulsifiers, increasing agents, antimicrobials, antioxidants)
    • Types of semi-solids: creams, gels, ointments, and pastes

    Special Attributes

    • Bioavailability factors (area, residue, formulation)
    • Sterility and contamination-free conditions
    • Chemical stability (solutions vs. decomposition)
    • Physical deterioration (separation)
    • Local or systemic effects
    • Include ointments, creams, lotions, and pastes
    • Special attributes for each type.

    Signs of Physical Instability

    • Change in consistency
    • Discoloration
    • Emulsion breakdown
    • Crystal growth
    • Shrinking (water evaporation)
    • Microbial growth
    • Odor change
    • Instability Signs: consistency, discoloration, emulsion breakdown, crystal growth, shrinking, microbial presence, odor change

    Factors to Consider

    • Skin penetration phases (penetration, permeation, and absorption)
    • Treatment of skin diseases (aqueous/lipid solubility)
    • Animal fats (e.g., lard, wool-emulsion base and drug release)
    • Greasy bases and skin function interference (sweating)
    • Important factors: skin phases, treatment consideration, oily bases impact, and other critical elements.

    Pharmaceutical Factors

    • Drug penetration properties based on drug's and vehicle's physicochemical properties; skin condition
    • Base stability (rancidity and antioxidants) and drug release rate considerations
    • Solvent properties (and issues with insoluble bases)
    • Emulsifying properties (and issues with water)
    • Consistency maintenance across temp. changes
    • Drug permeability coefficient

    Emulsions Types

    • Oil-in-water (o/w)
    • Water-in-oil (w/o)
    • Multiple emulsions (w/o/w or o/w/o)
    • Microemulsions-formed when components are mixed in appropriate ratios.
    • Types: Oil-in-water (o/w), water-in-oil (w/o), multiple emulsions (w/o/w or o/w/o), microemulsions.

    Rheology

    • Study of deformation, flow properties of matter.
    • Viscosity measures resistance to flow
    • Newtonian fluids (constant)
    • Non-Newtonian fluids (plastic flow, pseudoplastic flow, dilatant flow, thixotropy)
    • Thixotropy (time-dependent shear thinning): understanding how rheology affects different forms.
    • Types of flow: Newtonian and Non-Newtonian types (plastic, pseudoplastic, dilatant, thixotropy)

    Ointments

    • Semisolid preparations for external application to skin/mucous membranes
    • Viscous (e.g., petrolatum)
    • Oleaginous/polymeric (e.g., polymers, fats)
    • Can contain drug
    • Used for minor skin infections, itching, burns, diaper rash, etc.
    • Types: viscous and oleaginous/polymeric

    Ideal Properties

    • Smooth texture
    • Elegant appearance
    • Non-dehydrating
    • Non-gritty, non-greasy
    • Non-staining
    • Non-hygroscopic
    • Non-irritating
    • Does not alter membrane/skin functions
    • Miscible with skin secretions (low sensitization index)
    • Ideal properties for each semi-solid

    Oleaginous Bases

    • Hydrophobic
    • Anhydrous (Water insoluble)
    • Not water washable
    • Oily, occlusive
    • Cosmetic issues with appearance
    • Poor drug release
    • Type of base: hydrophobic

    Absorption Bases

    • Properties between oleaginous and water-in-oil bases
    • Less occlusive, moderate spreadability
    • Easier to incorporate small amounts of water (limited)
    • Easier to spread than oleaginous bases
    • Type of base: absorption

    Water-Soluble Bases

    • Water washable (water soluble)
    • May or may not contain water
    • Can absorb a limited amount of water
    • Less occlusive
    • Moderate to easy spreadability
    • Good drug release
    • Non greasy
    • Bases: polyethylene glycols (PEGs), polyoxyl 40 stearate, polysorbates
    • Type of base: water-soluble

    Preparation

    • Ways to prepare ointments via incorporation (Levigation, geometric dilution, fusion)
    • Tools: slabs, metal spatulas, pads, mills, unguators
    • Different types of semi-solid preparation methods

    Ointment Packaging

    • Large-mouthed ointment jars/tubes
    • Well-closed
    • Store in cool, dry place (away from heat)
    • Protect from light, consider light sensitivity
    • Crucial packaging design considerations

    Clinical Instructions

    • Wash affected area
    • Apply thin layer of medication
    • Fingertip application for even spreading
    • Avoid bandages unless instructed
    • Patient instructions

    Viscosity

    • Relationship between viscosity and sedimentation important in formulations
    • Viscosity properties for different semi-solid forms

    Hand Molding

    • Not commonly used anymore
    • Weigh ingredients
    • Shred cocoa butter
    • Mix ingredients
    • Apply heat
    • Shape and form
    • Advantages/disadvantages compared to other methods

    Fusion

    • Melt base first
    • Disperse/dissolve drug in base
    • Pour into mold
    • Most commonly used method
    • Fusion method advantages/disadvantages

    Quality Control

    • Appearance, uniformity, weight/volume
    • Viscosity, clarity, pH
    • Storage considerations (tight containers, appropriate temps, avoid heat, light)
    • Importance of quality control

    Additional Topical Formulations

    • Pastes (thick, stiff, nonflow at room temp, protective coatings)
    • Lotions (aqueous, typically for lubrication)
    • Other types of semi-solids

    Suppositories

    • Solid dosage forms for insertion in body orifices,
    • Melt, soften, or dissolve for local or systemic effects
    • Commonly used rectally, vaginally, urethrally
    • Historical use of various materials
    • Types: rectal (cylindrical/conical), vaginal, and urethral

    Rectal/Vaginal Preparations

    • Different examples for use
    • Considerations for different regions.

    Disadvantages of Rectal/Vaginal Suppositories

    • Not a patient favorite
    • Absorption unpredictable and variability
    • Issues with leakage or expulsion
    • Other disadvantages and considerations

    Vaginal Suppositories (Pessaries)

    • Typically use water soluble bases
    • Avoids issues with some bases "leaking"
    • Various types are formulated
    • Preparation methodology and related factors

    Suppository Base Properties (and Problems with Cocoa Butter)

    • Bases need to melt, soften, or dissolve, to release drug
    • Cocoa butter has polymorphs (e.g., gamma, alpha, beta) with differing melting points
    • Difficulties with cocoa butter (water absorption/oxidation)
    • Better alternatives (synthetic triglycerides, other waxes).
    • Consideration of melting point and stability attributes

    Important Counseling Points

    • Refrigerator usage, handling precautions
    • Beyond-use date considerations specific to non-sterile/sterile products
    • Important instructions specific to handling and storage

    Methods of Preparation

    • Hand rolling, compression molding (machine-based), and fusion molding types
    • Semisolid preparation methods

    Physical Factors

    • Colonic (empty/distended) and vaginal content (factors impacting drug delivery)
    • Circulation (bypasses first-pass, specific routes)
    • Characteristics of rectal fluids and buffering
    • Physiological factors and their specific considerations relevant to the application

    Physicochemical Factors

    • Particle size and drug solubility in vehicle (affecting release and absorption)
    • Base nature (needs to melt, soften, or dissolve for drug release)
    • Spreading capacity (applicable in topical delivery)

    Other factors, Considerations, and Clinical Instructions

    • Discusses and details further issues and considerations about the various applications, safety, and other guidance points.

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    Related Documents

    Pulmonary Drug Delivery PDF
    Semisolid Dosage Forms PDF
    Parenterals PDF

    Description

    Test your knowledge on the factors influencing drug penetration, release, and formulation of topical products. This quiz covers concepts related to dermatologicals, their consistency, and bioavailability. Evaluate your understanding of semi-solids and their properties in skin applications.

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