Injectable Solutions and Stability
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Questions and Answers

What are solid consistency preparations that contain a dosage unit of one or more active substances called?

Tablets

What ingredient is essential to bond particles that cannot be compressed alone?

Binder

What is used to increase tablet size when the active ingredient is insufficient?

Diluent

When should lubricants be added during tablet preparation?

<p>At the beginning of dry mixing</p> Signup and view all the answers

What issue can arise from the use of excessive lubricant in tablet formulation?

<p>Tablet friability</p> Signup and view all the answers

What is the primary role of disintegrants in tablet formulations?

<p>Accelerate disintegration</p> Signup and view all the answers

What is the purpose of granulation in tablet manufacturing?

<p>To increase powder density</p> Signup and view all the answers

What shape is typically associated with a punch used in tablet compression machines?

<p>Nail-shaped</p> Signup and view all the answers

What is the position of the hopper and hoof during the ejection process in the alternative machine?

<p>They are moving horizontally to feed the matrix and push the tablet out.</p> Signup and view all the answers

What are parenteral preparations intended for?

<p>They are sterile preparations intended to be injected or implanted in the human or animal body.</p> Signup and view all the answers

How can the average weight of the tablets be increased in the alternate machine?

<p>By lowering the lower punch.</p> Signup and view all the answers

What action affects the hardness of the tablets in an alternate machine?

<p>Lowering the upper punch.</p> Signup and view all the answers

How can precipitates be removed from injectable solutions?

<p>By clarifying filtration using the 0.22 μm millipore filter.</p> Signup and view all the answers

What is considered the fixed part in a rotary machine?

<p>The hopper and hoof.</p> Signup and view all the answers

What is the typical pH range of body fluids?

<p>The pH range of body fluids is 7.35 to 7.45.</p> Signup and view all the answers

What is the control method for uniformity of weight in tablets?

<p>At least 18 tablets should fall within the range [AW±e].</p> Signup and view all the answers

What adjustment is made if an active pharmaceutical ingredient is only stable at pH 3?

<p>Acidify with hydrochloric acid.</p> Signup and view all the answers

What causes longer pain in buffered injectable solutions?

<p>The competition of drug buffer and tampons of the body.</p> Signup and view all the answers

What should be done to resolve a pH problem in eye drops if its active principle is stable outside neutrality?

<p>Adjust the pH with acids or bases.</p> Signup and view all the answers

What is the purpose of NaCl in eye drops?

<p>It adjusts the osmotic pressure.</p> Signup and view all the answers

What is the concentration of NaCl in an isotonic solution?

<p>The concentration of NaCl is 0.9%.</p> Signup and view all the answers

What defines a semi-solid preparation intended for skin application?

<p>They exert a local action or facilitate percutaneous penetration of medicinal principles.</p> Signup and view all the answers

What is the boiling point of syrup?

<p>The boiling point of syrup is 105°C.</p> Signup and view all the answers

Why is more sugar used in preparing cold simple syrup than in hot preparation?

<p>Due to the evaporation of steam during heating.</p> Signup and view all the answers

What is the mass of cocoa butter needed to prepare 10 suppositories of 0.1 g phenobarbital with a displacement factor of 0.62?

<p>29.38 g</p> Signup and view all the answers

What is the definition of rectal capsules?

<p>Soft capsules of slightly elongated shape containing an active principle and a pasty or liquid excipient.</p> Signup and view all the answers

What form of medicine is intended to be introduced into the woman's sexual cavity?

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

What method involves melting the excipient and incorporating active ingredients into molds?

<p>Method of preparing ovules</p> Signup and view all the answers

How are ovules typically packaged?

<p>PVC / Alu Blisters</p> Signup and view all the answers

What is the standard disintegration time for ovules?

<p>60 minutes</p> Signup and view all the answers

What do you call liquids intended to wash the throat?

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

What size of particles can penetrate the nasal cavity?

<blockquote> <p>30 μm</p> </blockquote> Signup and view all the answers

What are semi-solid preparations intended for multi-phase skin application called?

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

What types of emulsifying agents are sodium soaps, sulfated fatty alcohols, and polysorbates classified as?

<p>Emulsifying agents type L/H</p> Signup and view all the answers

What are semi-solid preparations formed from liquids gelled by gelling agents called?

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

What is the main principle of preparing hydrophobic gels?

<p>Dissolve or disperse one or more p.a. in hydrophobic gelling agents.</p> Signup and view all the answers

What impact does the pH of the PSSAC have on medication penetration through the skin?

<p>It influences the degree of ionization of ionizable active ingredients.</p> Signup and view all the answers

Why is kneading important during the manufacturing of PSSACs?

<p>To avoid the separation of excipients.</p> Signup and view all the answers

How is homogeneity in PSSAC checked?

<p>By thin-layer spreading on a flat surface using a spatula.</p> Signup and view all the answers

What apparatus is used to measure the hardness of ointments?

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

Flashcards

Parenteral Preparations

Liquid preparations specifically designed for injection or implantation into a living organism, whether human or animal.

Clarifying Filtration for Injectables

Sterile filtration using a 0.22 μm filter is a common method to remove particles like precipitates, crystals, and fibers from injectable solutions.

pH of Body Fluids

The normal pH range of body fluids, such as blood, is between 7.35 and 7.45.

pH Neutrality for Injectables

Injectable preparations generally aim for a pH close to neutral, mimicking the natural pH of body fluids. Deviating too far from neutrality can cause discomfort or irritation.

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Body Tolerance and pH

The tolerance of the body to a specific pH plays a significant role in determining the acceptable pH range for injectable preparations.

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Acidification for Injectable Stability

If an active ingredient is only stable at a pH significantly different from neutral, acidification with hydrochloric acid can help adjust the pH for injectable use.

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Buffering for Injectable Stability

A buffer system is often employed to maintain the pH within a desired range, especially when the API is stable in a slightly acidic or basic environment.

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Sterile Powder Formulation for Instability

If the active ingredient is inherently unstable at any pH, a sterile powder formulation can be used. The active ingredient is dissolved only at the time of use, ensuring stability and avoiding degradation.

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Tablet Definition

A solid dosage form prepared by compressing particles of active substances and excipients together.

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Binder

A substance that binds particles together during tablet compression, allowing for a stable tablet.

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Diluent

A substance used to fill the tablet to the desired size when the active ingredient is insufficient.

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Lubricant

A substance that helps reduce friction during tablet compression, preventing sticking and ensuring smooth tablet ejection.

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Disintegrant

A substance that accelerates the disintegration of tablets in the presence of water, allowing for drug release.

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Sodium Lauryl Sulfate

A wetting agent that helps the tablet quickly come into contact with water for faster disintegration.

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Granulation

A powder that helps increase the density of the tablet, resulting in a more stable and less brittle product.

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Granulator

A machine used to process powders into granules during tablet manufacturing.

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Uniformity of Weight

The process of ensuring that the weight of each tablet produced by a tablet press falls within a specific range, with a minimum number of tablets meeting a specific weight threshold.

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Eye Drops

A liquid preparation intended for instillation into the eye, containing one or more medicinal substances dissolved or suspended in a sterile aqueous or oily vehicle.

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pH of Eye Drops

A critical factor in eye drop formulation, the pH of the solution needs to be carefully adjusted, ensuring that it both remains stable and does not cause irritation to the eye.

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Boric Buffer

A specific type of buffer often used in eye drop formulations to maintain the appropriate pH level, helping to ensure eye comfort and stability.

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Phosphoric Buffer

A specific type of buffer often used in eye drop formulations, helping to maintain the appropriate pH level for eye comfort and stability.

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Osmotic Pressure in Eye Drops

The salt concentration in eye drops is closely related to the osmotic pressure in the eye. Maintaining a similar salt concentration helps prevent irritation and discomfort.

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Semi-Solid Preparation for Cutaneous Application (SSPCA)

A semi-solid preparation intended for topical application to the skin or certain mucous membranes, designed for local action or for the delivery of medicinal substances through the skin.

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Hydrophobic Ointments

Ointments where the base consists of hydrophobic (lipophilic) excipients, such as oils and fats, used to dissolve or disperse one or more active pharmaceutical ingredients (APIs).

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Cream

A semi-solid preparation designed for multi-phase skin application, containing both oil-based (lipophilic) and water-based (aqueous) components.

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Emulsifying Agents

Substances that help blend oil and water together, often used in creams.

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Gel

Gel-like preparations consisting of a liquid component solidified by a gelling agent.

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Hydrophobic Gel

A type of gel where the active ingredient is dissolved or dispersed in a hydrophobic (water-repelling) gelling agent.

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Hydrophilic Gel

A type of gel where the active ingredient is dissolved or dispersed in a hydrophilic (water-attracting) excipient and then gelled by a hydrophilic gelling agent.

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PSSAC and Medication Penetration

The pH of a semi-solid preparation can affect how easily an active ingredient penetrates the skin.

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Kneading for PSSACs

During the manufacture of semi-solid preparations, thorough kneading is essential to prevent the separation of ingredients.

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Suppository

Solid preparations intended for rectal administration, often used for localized or systemic effects.

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Ovule

A solid dosage form, usually oval-shaped, designed to be inserted into the vagina for local action.

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Ovule Preparation Method

A method for preparing ovules where the base is melted, the drug is incorporated, poured into molds, cooled, and then removed and cooled down.

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Ovule Disintegration Standard

The time it takes for an ovule to disintegrate completely in a specified liquid medium, typically within 60 minutes.

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Gargarism

A liquid dosage form intended for gargling, used to cleanse and soothe the throat.

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Collutoires

Liquids applied by brushing or spraying to the mouth and throat for local action.

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Nasal Preparations

Dosage forms intended for use in the nasal cavity, available as drops, sprays, powders, ointments, and wash solutions.

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Inhalation Preparations

Dosage forms for use in the lower respiratory tract, including solutions, emulsions, suspensions, powders, tablets, and capsules.

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Drug Rhinitis

An overuse of vasoconstrictors, often in nasal preparations, leading to a chronic condition with symptoms like nasal congestion and runny nose.

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Study Notes

Injectable Solutions

  • Sterile preparations for injection or implantation in humans or animals
  • Parenteral use is the classification
  • Filtration using a 0.22 µm millipore filter for removing precipitates, crystals, and fibers
  • Body fluids have a pH range of 7.35 to 7.45

Injectable Preparation pH

  • Injectable preparations need a neutral pH, ideally matching body fluid pH
  • pH tolerance by the body is a critical condition to maintain
  • If API (active pharmaceutical ingredient) is stable only at pH 3, acidify with hydrochloric acid
  • If API is stable at pH 5–6, buffer with a pH buffer of about 5–6

Injectable Solution Instability

  • If the solution of the active ingredient is unstable at any pH, present the active substance in sterile powder for dissolution at the time of use

Isotonic Solutions

  • Isotonic solutions do not cause swelling or distortion of erythrocytes
  • Isotonic NaCl concentration is 0.9%
  • Isotonic glucose concentration is 5%

Hemolysis

  • Hemolysis (rupture of red blood cells) occurs above 0.48% NaCl concentration

Syrups

  • Aqueous liquid preparations high in sugar
  • Provide consistency and preservation
  • Cold simple syrup: 1800g sugar per 1000g water
  • Hot single syrup (closed container): 1800g sugar per 1000g water
  • Hot single syrup (open container): 1650g sugar per 1000g water

Boiling Point of Syrup

  • 105°C

Syrup Density

  • Density at 25°C = 1.32
  • Density at the boil = 1.26

Tablet Preparation

  • Solid preparations containing one or more active substances
  • Made by compressively agglomerating a constant volume of particles

Tablet Ingredients

  • Binder: Bonds particles for proper tablet formation
  • Diluents: Used when the active ingredient alone is insufficient for a suitable tablet size
  • Lubricants:Added at the beginning of dry mixing.
  • Disintegrants: Speed up disintegration of tablets
  • Wetting Agents: Ex: Sodium Lauryl Sulfate. Helps in the wetting action of the granules within tablets

Tablet Additives

  • Flavoring: Masks unpleasant tastes/odors
  • Absorbents/Adsorbents: Retain volatile principles.

Granulation

  • Granulation increase powder density, which is crucial for tablet production
  • Granulation is done in a granulator

Tablet Shapes

  • Die (matrice): Hole drilled cylinder shape
  • Punch: Nail-shaped
  • Hopper and hoof: J-shaped

Tablet Machines

  • Reciprocating machine: Lower punch is in a low position before feeding, and the upper is raised during feeding
  • Alternative machine: Hopper and hoof are above the compression chamber before feeding.

Eye Drops

  • Active compound: Stable pH outside normal neutrality range (acidic or basic)
  • pH: Adjusting the pH to a range compatible with tolerance of the eye, between limits of API stability and safety
  • Sterile powder: For dissolution at the time of use if solution unstable

Semi-Solid Preparations

  • Ointments: Hydrophobic or hydrophilic types
  • Gels: Liquids gelled with appropriate gelling agents
  • Creams: Semi-solid, multi-phase application
  • Gargarisms: Liquids for throat gargling
  • Collutoires: Applied to oral mucous membranes for local effect
  • Nasal Preparations: Including drops, sprays, powders, ointments
  • Inhalation Preparations: Used by the respiratory systems for local or systemic effect
  • Suppositories: Fusible, dispersible, or soluble preparations
  • Ovules: Solid preparation intended for local use in the vagina/uterus

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Description

This quiz covers essential concepts related to injectable solutions, including their preparation, pH requirements, and stability. Understand the impact of isotonic solutions on body fluids and the principles of hemolysis. Test your knowledge on the conditions necessary for safe and effective injectable medications.

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