130 - Quiz 2
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Questions and Answers

What is the primary factor influencing the design of the optimum dosage form for a drug?

  • Literature searches in the pre-discovery stage
  • Safety and efficacy in human subjects
  • Preclinical research results
  • Dissolution and absorption of the active pharmaceutical ingredient (API) (correct)

What is the purpose of preformulation studies in drug development?

  • Monitoring adverse reactions in patients
  • Assessing short-term side effects of drugs
  • Conducting clinical trials on human subjects
  • Determining characteristics of active substances and excipients (correct)

In which phase of drug development do safety, efficacy, and monitoring of adverse reactions take place?

  • Phase II
  • Phase III (correct)
  • Pre-discovery stage
  • Phase I

What process occurs in the pre-discovery stage of drug development?

<p>Literature searches and disease understanding (C)</p> Signup and view all the answers

What percentage of drugs usually move from Phase II to Phase III of drug development?

<p>25% to 30% (A)</p> Signup and view all the answers

Which phase of drug development focuses on determining the safety and dosage of the drug?

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

What is the purpose of pharmacovigilance in drug development?

<p>Reporting adverse drug reactions (C)</p> Signup and view all the answers

What is the key focus of Phase II in drug development?

<p>Monitoring safety and efficacy (A)</p> Signup and view all the answers

What is the purpose of in-vitro screening in drug development?

<p>To prove the chemical activity of the drug using cell lines, enzymes, and chemical tests (B)</p> Signup and view all the answers

What is the main purpose of in-vivo screening in drug development?

<p>To determine the effective dose of the drug (D)</p> Signup and view all the answers

What needs to be submitted first before proceeding to clinical trials?

<p>Investigational New Drug Application (C)</p> Signup and view all the answers

What was given the project code 7901 at the University of the Philippines - College of Pharmacy?

<p>Clinical trial plan (B)</p> Signup and view all the answers

What was lacking in local pharmaceutical companies regarding herbal medicines manufacturing according to the text?

<p>Manufacturing herbal medicines (C)</p> Signup and view all the answers

What process must be completed before proceeding to clinical trials?

<p>Pre-clinical test results submission (B)</p> Signup and view all the answers

Why is amorphous insulin used for rapid onset effects?

<p>It has a disorderly manner (B)</p> Signup and view all the answers

Which type of insulin is used for longer duration of action?

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

What defines amorphous solids?

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

Why is differentiation between crystalline and amorphous solids important for insulin?

<p>To ensure a correct dose and patient safety (B)</p> Signup and view all the answers

Why should we ensure the stability of a drug or drug product according to the text?

<p>To care for patient's health and safety (C)</p> Signup and view all the answers

What role do polymers play in pharmaceutical formulations?

<p>Act as excipients for API stability (C)</p> Signup and view all the answers

How do crystalline insulin and amorphous insulin differ in terms of administration?

<p>Crystalline is used for long duration, amorphous for rapid onset (C)</p> Signup and view all the answers

Why are amorphous solids easily dissolved in water?

<p>They have a disorderly manner (B)</p> Signup and view all the answers

What ensures that the correct dose and no toxic substances are produced over time according to the text?

<p>'Quality Assurance' processes (B)</p> Signup and view all the answers

Why is it essential to know the melting points of the polymorphs of cocoa butter?

<p>To determine the suitable formulation for dosage forms (C)</p> Signup and view all the answers

What is the significance of cocoa butter melting at normal body temperature?

<p>It ensures easy handling during suppository preparation (A)</p> Signup and view all the answers

Which characteristic of different polymorphs can significantly affect drug bioavailability and stability?

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

Why is the B1 polymorph of cocoa butter considered the best suppository base?

<p>It prevents suppositories from melting in hands (A)</p> Signup and view all the answers

What is the primary reason for using cocoa butter as a suppository base?

<p>To enhance drug stability and absorption rate (C)</p> Signup and view all the answers

How does knowing the melting points aid in selecting polymorphs for formulation?

<p>It assists in determining suitable dosage form preparations (D)</p> Signup and view all the answers

In what way can different polymorphs affect drug bioavailability?

<p>By altering drug absorption and stability (D)</p> Signup and view all the answers

What factor makes B1 polymorph ideal to prevent suppositories from melting in one's hands?

<p>Its close proximity to room temperature melting point (C)</p> Signup and view all the answers

Why is it important to add as few ingredients as possible when formulating suspensions?

<p>To prevent incompatibility issues (C)</p> Signup and view all the answers

In the context of pharmaceutical formulations, why is cost-effectiveness a critical factor when selecting excipients for an API?

<p>To minimize manufacturing costs (B)</p> Signup and view all the answers

What is the primary purpose of dissolution testing in pharmaceuticals?

<p>To measure the rate at which a drug dissolves in any medium (C)</p> Signup and view all the answers

How does selecting a suitable excipient for an API contribute to ensuring drug stability?

<p>By reducing the risk of incompatibility issues (B)</p> Signup and view all the answers

Why is it important to consider a solvent's ability to dissolve an API when formulating pharmaceuticals?

<p>To ensure effective delivery and absorption of the drug (B)</p> Signup and view all the answers

How does an increase in wettability of particles affect dissolution rate?

<p>Causes a high dissolution rate (D)</p> Signup and view all the answers

What role do bigger pores play in the dissolution process?

<p>Facilitate easier diffusion and solubilization (A)</p> Signup and view all the answers

How do particle size and surface area correlate with dissolution rate?

<p>Larger surface area increases dissolution rate (B)</p> Signup and view all the answers

Which API property directly influences dissolution rate?

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

How does the biological fluid system pH affect dissolution rate?

<p>Acidic pH decreases dissolution rate (D)</p> Signup and view all the answers

What is the main concern when dealing with saturated solutions and the solubility of APIs?

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

In pharmaceutical formulation, why is it crucial to combine oil-soluble ingredients with oil and water-soluble ingredients with water?

<p>To prevent phase separation (D)</p> Signup and view all the answers

What factor does not contribute to the Absolute (Intrinsic) Solubility of a drug compound?

<p>Presence of polymorphs (D)</p> Signup and view all the answers

Why is it important to consider intermolecular forces of attraction (IMFAs) when formulating dosage forms?

<p>To control solubility (A)</p> Signup and view all the answers

What term describes the point at which an API starts to precipitate due to exceeding its solubility in a solution?

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

What is a key consideration when dealing with drug dissolution?

<p>The partition coefficient of the drug (B)</p> Signup and view all the answers

Why is it important to avoid precipitation of ingredients in a solution?

<p>To ensure proper solubility of the drug (B)</p> Signup and view all the answers

What relationship does calcium compounds exhibit between solubility and temperature?

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

Why is understanding the crystal form (amorphous vs crystalline) important in drug release?

<p>To control the drug's dissolution rate (D)</p> Signup and view all the answers

In terms of stability, why are some solutions temperature-dependent in their solubility?

<p>To retain proper solubility under different conditions (D)</p> Signup and view all the answers

Why is it crucial for excipients to be physiologically inert?

<p>To enhance the stability and bioavailability of the active pharmaceutical ingredient (API). (A)</p> Signup and view all the answers

Which property of excipients is essential to prevent microorganism contamination in pharmaceutical formulations?

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

How does the presence of certain excipients influence drug bioavailability?

<p>By enhancing dissolution rate (C)</p> Signup and view all the answers

What role do excipients play in ensuring the stability of a drug product over time?

<p>They prevent physical changes in the drug product. (D)</p> Signup and view all the answers

Why must excipients be compatible with the active pharmaceutical ingredient (API)?

<p>To ensure no interference with drug bioavailability. (D)</p> Signup and view all the answers

What is the key factor influencing the partitioning of drugs across membranes?

<p>The drug's chemical composition (C)</p> Signup and view all the answers

Which statement best describes the concept of polymorphism in pharmaceutical compounds?

<p>Polymorphism involves the existence of a compound in more than one crystalline structure. (D)</p> Signup and view all the answers

How does the presence of preservatives in emulsions relate to drug stability?

<p>Preservatives prevent microbial attack on emulsions. (C)</p> Signup and view all the answers

What role do weak electrolytes play in the partitioning process between two immiscible liquids?

<p>Weak electrolytes affect the movement of molecules between phases. (A)</p> Signup and view all the answers

Why is understanding the difference between crystalline and amorphous solids crucial for drug formulation?

<p>It can significantly affect drug bioavailability and stability. (A)</p> Signup and view all the answers

What is the primary purpose of providing an enteric-coated layer to a dosage form?

<p>Protect the drug from degradation by enzymatic juices (D)</p> Signup and view all the answers

How does solubility affect the bioavailability of a drug?

<p>Lower solubility leads to higher bioavailability (A)</p> Signup and view all the answers

In pharmaceutical formulations, what role do excipients play?

<p>Control drug release rate (B)</p> Signup and view all the answers

Which factor determines the partition coefficient of a drug between two immiscible phases?

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

What is a key concern when determining drug stability under different conditions?

<p>Reactions leading to degradation (C)</p> Signup and view all the answers

Which property of excipients is essential for ensuring proper dissolution and absorption of the active pharmaceutical ingredient (API)?

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

Why is it important to address concerns related to drug stability in formulation development?

<p>To ensure drug efficacy and safety (C)</p> Signup and view all the answers

How does partitioning affect the distribution of a drug within the body?

<p>Affects where and how much of the drug reaches its target site (B)</p> Signup and view all the answers

What effect does crystal form have on the dissolution rate of a drug?

<p>Decreases dissolution rate (B)</p> Signup and view all the answers

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