Lec 2- Solid Dosage Forms: Compounding
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Questions and Answers

Which of the following is NOT a common solid dosage form?

  • Tablets
  • Elixirs
  • Powders (correct)
  • Capsules

What is the primary focus of pre-formulation studies in compounding?

  • Packaging design
  • Color selection
  • Solubility and Stability (correct)
  • Taste masking

What is the purpose of bioavailability in dosage form design?

  • To ensure patient compliance
  • To provide a pleasant taste
  • To allow the drug to exert its pharmacologic effect (correct)
  • To extend product shelf life

What role do excipients play in pharmaceutical formulations?

<p>Act as the main ingredient (B)</p> Signup and view all the answers

Which of the following is a common use of a mortar and pestle with a coarse surface?

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

What is the purpose of geometric mixing?

<p>To separate different components in a mixture (B)</p> Signup and view all the answers

Which of the following is a key application for solid dosage form powders?

<p>Drugs with a pleasant taste (B)</p> Signup and view all the answers

What is a 'diluent' in the context of tablet formulation?

<p>A bulking agent to provide tablet size (B)</p> Signup and view all the answers

What characterizes capsules as a dosage form?

<p>They are solid dosage forms in which drugs are enclosed in a shell. (B)</p> Signup and view all the answers

What should be considered when using an electronic balance?

<p>The humidity of the room (B)</p> Signup and view all the answers

Which solid dosage form is often prepared by molding or compression?

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

Which type of capsule is designed to hold powders, semisolids, or liquids?

<p>Enteric-coated (B)</p> Signup and view all the answers

What is the primary use of powders in reconstitution?

<p>To increase stability (C)</p> Signup and view all the answers

Which calculation is crucial in pharmaceutical compounding?

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

What technique reduces particle size?

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

What is the main focus of pre-formulation studies?

<p>Drug properties, especially solubility and stability (B)</p> Signup and view all the answers

What is essential for patient compliance regarding the dosage form?

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

What is the role of the 'Active Pharmaceutical Ingredient' (API) in a dosage form?

<p>The reason to take the dosage form (C)</p> Signup and view all the answers

What is the function of excipients in pharmaceutical formulations?

<p>To mask the need for refrigeration (B)</p> Signup and view all the answers

Why is packaging important?

<p>Only to meet legal requirements (C)</p> Signup and view all the answers

What is a 'diluent' used for in tablet formulation?

<p>To aid in disintegration (B)</p> Signup and view all the answers

What is magnesium stearate commonly used for?

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

What is the purpose of enteric coating?

<p>To provide flavor (C)</p> Signup and view all the answers

What should be protected from moisture and heat?

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

What is a key function of a coarse mortar and pestle?

<p>Measuring liquid volumes (D)</p> Signup and view all the answers

What is a key application for solid dosage form powders?

<p>Improved taste masking (B)</p> Signup and view all the answers

What is a ‘binder’ in the context of tablet formulation?

<p>A substance that causes the tablet to swell and burst (D)</p> Signup and view all the answers

What characterizes capsules?

<p>They are always chewable. (B)</p> Signup and view all the answers

Which of the following is a common use of trituration?

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

What is the purpose of using a levigating agent in compounding?

<p>To increase the volume of a powder (B)</p> Signup and view all the answers

What is the primary reason for pulverization by intervention?

<p>To increase a compound's stability (C)</p> Signup and view all the answers

Which type of tablet is designed to dissolve under the tongue?

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

What is a key advantage of capsules?

<p>They can be available in different sizes, shapes and colors. (B)</p> Signup and view all the answers

Why should powders not be used for drugs with a disagreeable taste?

<p>Powders cannot mask the taste of drugs (A)</p> Signup and view all the answers

What is something to watch for when compounding?

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

Which type of mortar and pestle should not be used with potent drugs?

<p>Porcelain mortar and pestle (D)</p> Signup and view all the answers

What should a pharmacist ensure about an electronic balance before using it?

<p>It is aesthetically pleasing. (B)</p> Signup and view all the answers

What is the general rule for storing solid dosage forms?

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

What is a good capsule size to select when compounding?

<p>The size with the coolest color. (C)</p> Signup and view all the answers

What kind of paper should be used when packing capsules?

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

Why should capsules be weighed after packing?

<p>Because it extends shelf life (B)</p> Signup and view all the answers

What solid dosage form can be altered most easily for medication dose?

<p>Controlled-release tablets (C)</p> Signup and view all the answers

What character trait promotes the success of solid dosage forms?

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

When are film coatings used in solid dose compounds?

<p>Preventing degradation due to the environment (D)</p> Signup and view all the answers

Which of these describes the nature of divided powder?

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

Which of the following is a solid dosage form?

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

Which of the following tablet types is designed to dissolve in the mouth?

<p>Film-coated (A)</p> Signup and view all the answers

What does 'API' stand for in pharmaceutical compounding?

<p>Average Pharmaceutical Impact (B)</p> Signup and view all the answers

Ascorbic Acid is an example of what?

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

What is the purpose of a humectant?

<p>Prevent the growth of bacteria. (A)</p> Signup and view all the answers

What type of mortar and pestle is best for reducing the particle size of hard crystals?

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

What is the first step in compounding approach?

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

What is a key factor when selecting a solid dosage form?

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

Which of these characteristics applies to solid dosage form powders?

<p>Difficult to administer (A)</p> Signup and view all the answers

What is the purpose of 'tare' when using an electronic balance?

<p>To calibrate the balance (B)</p> Signup and view all the answers

Which of the below is NOT a type of tablet?

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

Which of the following describes a capsule?

<p>A gas for inhalation (A)</p> Signup and view all the answers

Which technique involves reducing particle size by using a solvent that is later evaporated?

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

What is one reason powders are not typically used for drugs with a disagreeable taste?

<p>They are difficult to measure accurately. (B)</p> Signup and view all the answers

Before using an electronic balance, what should a pharmacist ensure?

<p>The balance has been recently cleaned with water. (C)</p> Signup and view all the answers

What type of substance is lactose used for in compounding?

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

What should be protected from moisture and heat to ensure stability?

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

Which of the following is a common application for solid dosage form powders?

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

What best describes capsules?

<p>Semi-solid dosage forms for topical application (A)</p> Signup and view all the answers

Trituration is best described as what?

<p>The dry grinding of a substance to reduce particle size (C)</p> Signup and view all the answers

What is the use for a levigating agent in compounding?

<p>To increase the solubility of a drug (A)</p> Signup and view all the answers

What is the main goal of pulverization by intervention?

<p>To improve the taste (C)</p> Signup and view all the answers

Which of the following tablet types is designed to be placed under the tongue for absorption?

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

Why should capsules generally be weighed after packing?

<p>Ensure it is not broken (A)</p> Signup and view all the answers

What should be watched for when compounding?

<p>New drug releases (A)</p> Signup and view all the answers

Which of the following is a source of API?

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

Which is NOT an application of geometric mixing?

<p>Mix all ingredients at the same time (D)</p> Signup and view all the answers

What is a common use of a coarse mortar and pestle?

<p>Mixing with a levigating agent (B)</p> Signup and view all the answers

Which packaging is considered during dosage from fundamentals?

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

Which characteristic applies to solid dosage form capsules?

<p>Provides dosing flexibility (A)</p> Signup and view all the answers

What is the name of the bulking agent to provide a tablet's size?

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

Which administration can bulk powders use?

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

Which solid dosage form is made by molding or compression?

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

What kind of capsules can hold powders, semisolids, or liquids?

<p>Soft gelatin capsules (B)</p> Signup and view all the answers

What type of powders are used in reconstitution?

<p>Powders for solution (D)</p> Signup and view all the answers

What is required for patient compliance regarding dosage forms?

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

What is the role of the 'Active Pharmaceutical Ingredient' (API)?

<p>To provide bulk to the dosage form (C)</p> Signup and view all the answers

What is the purpose of using magnesium stearate?

<p>As a coloring agent (B)</p> Signup and view all the answers

What is a ‘binder’ used for in tablet formulation?

<p>To make the tablet easier to swallow. (C)</p> Signup and view all the answers

What solid dosage form can easily have its medication dose altered?

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

What is the purpose of 'tare' on an electronic balance?

<p>To set the unit of measurement (C)</p> Signup and view all the answers

Which tablet is designed to dissolve in the mouth?

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

Which factor is key when selecting a solid dosage form?

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

What is the main focus of pre-formulation?

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

What is important to consider when compounding?

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

Which step is not involved with compounding approach?

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

What characteristic is the administration device packaging based on?

<p>The shape of the product (A)</p> Signup and view all the answers

What is a common use of a mortar and pestle with a smooth surface?

<p>Form an emulsion (C)</p> Signup and view all the answers

What should be considered when using a spatula?

<p>Metal vs Rubber (C)</p> Signup and view all the answers

Geometric mixing is primarily used to:

<p>Combine equal quantities of ingredients (C)</p> Signup and view all the answers

What is the common use of a diluent?

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

Which dosage form is characterized by enclosing a drug substance within a shell?

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

For which patient population are powders particularly advantageous due to ease of dose adjustment?

<p>Adults with dysphagia (C)</p> Signup and view all the answers

What is the primary focus of the pre-formulation stage in compounding a new solid dosage form?

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

Which objective of dosage form design is most directly related to a drug's therapeutic effectiveness?

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

What role do excipients primarily serve in a pharmaceutical formulation?

<p>Provide the therapeutic effect (C)</p> Signup and view all the answers

Why is packaging considered a fundamental component of a dosage form?

<p>To protect the dosage form's integrity (C)</p> Signup and view all the answers

If a drug is sourced as a 'modified drug,' what form might it likely be in?

<p>Pure, unadulterated powder (B)</p> Signup and view all the answers

Which type of excipient is used to maintain powder dryness and prevent caking?

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

Ascorbic acid is included in a formulation primarily as which type of excipient?

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

What is the function of a 'binder' in tablet formulation?

<p>To hold tablet ingredients together (C)</p> Signup and view all the answers

Shellac and gelatin are examples of excipients used for what purpose in solid dosage forms?

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

Lactose, mannitol, and cellulose are commonly used in tablets as:

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

Which type of coating is designed to prevent drug dissolution in the stomach but allow it in the intestines?

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

Sorbitol and glycerin function as what type of excipient, preventing preparations from drying out?

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

Magnesium stearate is primarily used in tablet manufacturing as a:

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

Sodium benzoate and benzalkonium chloride are added to formulations to act as:

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

What type of mortar and pestle is best suited for particle size reduction of hard crystalline solids?

<p>Electronic mortar and pestle (B)</p> Signup and view all the answers

What is the purpose of 'tare' function when using an electronic balance in compounding?

<p>To calibrate the balance (B)</p> Signup and view all the answers

Which particle size reduction technique involves dissolving a substance in a solvent and then evaporating the solvent to obtain a fine powder?

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

In geometric dilution (mixing), how are two or more powder ingredients typically combined to ensure uniform mixing?

<p>Ingredients are mixed based on particle size (C)</p> Signup and view all the answers

Why are tablets described as being available 'only in fixed dosage strengths' in commercial manufacturing?

<p>Tablets are always compounded, limiting flexibility (B)</p> Signup and view all the answers

Which type of tablet is designed to be placed under the tongue for rapid absorption?

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

In a typical uncoated tablet formulation, what is the role of a 'disintegrant'?

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

Why are powders generally not suitable for drugs with a very bitter or unpleasant taste?

<p>Powders are difficult to swallow (C)</p> Signup and view all the answers

For bulk powders, what is a crucial aspect of patient administration?

<p>Patient measurement of each dose (B)</p> Signup and view all the answers

In the batch size calculation for powders, if a prescription requires 3mg of drug per dose and #10 doses, and commercial tablets contain 12.5mg of the drug, how many tablets are needed?

<p>4 tablets (C)</p> Signup and view all the answers

If the target weight for a divided powder is 250mg, and you need to prepare 12.5 doses, what is the total blended weight?

<p>250 mg (B)</p> Signup and view all the answers

When compounding powder-filled capsules, what is the purpose of calibrating the capsule?

<p>To find out the approximate weight of powder a capsule will hold (C)</p> Signup and view all the answers

What is a key advantage of capsules over tablets in compounding settings?

<p>Lower manufacturing cost (B)</p> Signup and view all the answers

What type of paper is recommended for packing capsules during compounding?

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

Why is it important to weigh each capsule after packing in a compounding setting?

<p>To ensure uniformity of dosage (B)</p> Signup and view all the answers

When selecting a mortar and pestle, what is the primary consideration regarding the surface for emulsion formulation?

<p>Any surface is suitable for emulsion formulation (B)</p> Signup and view all the answers

What is the 'Lightest Weighable Quantity' (LWQ) referring to in the context of electronic balances used in compounding?

<p>The weight of the balance itself (B)</p> Signup and view all the answers

Which of the following techniques is considered a 'wet' method of particle size reduction?

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

What is the primary reason for using geometric mixing in powder compounding?

<p>To ensure uniform distribution of a potent drug in a larger amount of diluent (B)</p> Signup and view all the answers

Which factor is most critical for ensuring the stability of solid dosage forms during storage?

<p>Patient's age (B)</p> Signup and view all the answers

In the context of solid dosage form design, what is the most critical rationale for ensuring drug bioavailability?

<p>To extend the shelf life and stability of the pharmaceutical product. (C)</p> Signup and view all the answers

Considering the objectives of dosage form design, which factor primarily dictates the selection of packaging materials for solid dosage forms?

<p>The physicochemical properties of the drug substance and its stability requirements. (C)</p> Signup and view all the answers

In pharmaceutical compounding, what is the most significant implication of utilizing a 'modified drug' as the Active Pharmaceutical Ingredient (API) source?

<p>It ensures immediate drug release and rapid onset of action. (C)</p> Signup and view all the answers

Which of the following scenarios would most necessitate the use of geometric mixing in solid dosage form compounding?

<p>When incorporating a potent drug present in a minute quantity into a large amount of diluent. (B)</p> Signup and view all the answers

For which of the following solid dosage forms is 'calibration' of the container an essential step in the compounding process to ensure accurate dosing?

<p>Powder-filled capsules. (C)</p> Signup and view all the answers

What is the primary rationale for employing pulverization by intervention as a particle size reduction technique in pharmaceutical compounding?

<p>To reduce the cost of raw materials by minimizing waste. (C)</p> Signup and view all the answers

In the formulation of uncoated tablets, what is the principal role of a 'disintegrant' excipient?

<p>To enhance the tablet's mechanical strength and prevent friability. (C)</p> Signup and view all the answers

Considering patient compliance, which of the following characteristics of solid dosage forms is most directly influenced by the inclusion of flavoring agents and sweeteners?

<p>The physical stability and shelf life of the product. (C)</p> Signup and view all the answers

What is the most crucial consideration when selecting a mortar and pestle with a coarse surface for pharmaceutical compounding?

<p>To facilitate the formulation of emulsions by providing a rough surface for trituration. (B)</p> Signup and view all the answers

Which of the following techniques is considered a 'wet' method of particle size reduction and relies on the use of a non-solvent?

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

If a pharmacist needs to compound 10 powder packets, each containing 3 mg of an API sourced from commercial tablets that contain 12.5 mg of the API per tablet, what is the minimum number of tablets required for this compounding process?

<p>3 tablets. (C)</p> Signup and view all the answers

For a divided powder preparation requiring a target weight of 250mg per dose for 12 doses, what is the total blended powder weight that must be prepared?

<p>3125 mg. (B)</p> Signup and view all the answers

When compounding powder-filled capsules, what is the primary purpose of 'calibrating' the capsule using lactose before incorporating the active drug?

<p>To verify the accuracy of the electronic balance being used for compounding. (B)</p> Signup and view all the answers

Which type of paper is most appropriate for packing compounded capsules to ensure drug stability and prevent interactions?

<p>Waxed paper. (D)</p> Signup and view all the answers

Why is it essential to weigh each capsule individually after packing in a pharmaceutical compounding setting, especially for powder-filled capsules?

<p>To verify that each capsule contains the intended dose and ensure dose uniformity. (B)</p> Signup and view all the answers

What is the 'Lightest Weighable Quantity' (LWQ) of an electronic balance primarily designed to determine in pharmaceutical compounding practices?

<p>The average weight of excipients used in formulations. (B)</p> Signup and view all the answers

In the context of dosage form fundamentals, what is the most significant role of 'excipients' in a pharmaceutical formulation?

<p>To reduce the overall cost of manufacturing the dosage form. (C)</p> Signup and view all the answers

Which of the following scenarios best illustrates the application of pre-formulation studies in solid dosage form development?

<p>Conducting clinical trials to assess the efficacy of a drug product. (C)</p> Signup and view all the answers

What is the primary reason for using enteric coating on tablets or capsules in solid dosage form design?

<p>To enhance the mechanical strength and durability of the dosage form. (C)</p> Signup and view all the answers

Which of the following excipients is primarily used as a 'humectant' in pharmaceutical formulations?

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

In tablet formulation, what is the function of a 'binder'?

<p>To provide cohesive strength to the powder particles, holding them together in a tablet form. (D)</p> Signup and view all the answers

Which type of mortar and pestle is generally recommended for reducing the particle size of hard, crystalline solids in pharmaceutical compounding?

<p>Glass mortar and pestle with a smooth surface. (D)</p> Signup and view all the answers

What is the purpose of the 'tare' function on an electronic balance in pharmaceutical compounding?

<p>To record the weight measurements for documentation purposes. (C)</p> Signup and view all the answers

Which particle size reduction technique involves dissolving a substance in a solvent and then precipitating it out of solution to obtain a finer powder?

<p>Geometric dilution. (C)</p> Signup and view all the answers

In geometric dilution, how are two or more powder ingredients with significantly different quantities typically mixed to ensure homogeneity?

<p>By adding the larger quantity ingredient to the smaller quantity ingredient in a single step. (C)</p> Signup and view all the answers

Why are commercially manufactured tablets typically available 'only in fixed dosage strengths'?

<p>To enhance patient compliance by limiting dosage options. (C)</p> Signup and view all the answers

Which type of tablet is specifically designed to be placed under the tongue for rapid drug absorption and systemic effect?

<p>Chewable tablets. (C)</p> Signup and view all the answers

In a standard uncoated tablet formulation, what is the primary function of a 'lubricant' excipient?

<p>To reduce friction between the tablet and the die wall during compression and ejection. (C)</p> Signup and view all the answers

Why are powders generally considered unsuitable for drugs with a very bitter or unpleasant taste?

<p>Because powders are more expensive to manufacture than other solid dosage forms. (C)</p> Signup and view all the answers

For bulk powders, what is a critical aspect of patient administration that must be clearly communicated to ensure safe and effective use?

<p>The powder should be administered on an empty stomach for best absorption. (B)</p> Signup and view all the answers

In the context of capsule compounding, what is the primary advantage of using capsules over tablets for certain formulations prepared by a pharmacist?

<p>Capsules offer greater flexibility in accommodating various fill materials, including powders, liquids, and semisolids. (B)</p> Signup and view all the answers

If a compounded powder formulation is described as 'divided powder,' what does this designation primarily indicate about the dosage form?

<p>The powder is pre-portioned into individual doses, typically in packets or powder papers. (B)</p> Signup and view all the answers

Which of the following best describes the term 'comminution' in pharmaceutical compounding?

<p>The act of reducing particle size of a solid material. (C)</p> Signup and view all the answers

Flashcards

What are Powders?

Dosage forms consisting of mixtures of dry, finely divided drugs and excipients for internal or external application.

What are Capsules?

Dosage forms in which unit doses of powder, semisolid, or liquid drugs are enclosed in a hard or soft shell.

What are Tablets?

Solid preparations, each containing a single dose, made by compressing or molding.

What is Comminution?

The process of reducing the particle size of a solid material.

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What is Geometric Mixing?

A technique for ensuring uniform distribution of a potent drug within a larger quantity of diluent or excipient.

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What are Excipients?

A substance added to the API to: support absorption/stability, accomplish dosage , or needed for manufacturing.

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What is Bioavailability?

The extent to which the active drug becomes available at the site of action after administration.

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Mortar and Pestle

Mortars with a rough inner surface are used for particle size reduction. Mortars with a smooth inner surface are used for mixing.

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What is Packaging?

Ensuring stability, protecting from moisture/heat, and use of appropriate container depending on usage.

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What is API (Active Pharmaceutical Ingredient)?

The active drug in a pharmaceutical product.

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Types of Tablets

Uncoated, coated (functional and non-functional), chewable, sublingual, buccal, effervescent, oral disintegrating.

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Types of Capsules

Solid-filled, liquid-filled, semisolid-filled.

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Types of Powders

Powders for reconstitution, divided powders and bulk powders.

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Molded vs. Compressed Tablets

Molded tablets are prepared using a mold; compressed tablets are made by compacting the ingredients.

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Focus of Pre-formulation

Solubility and stability of the drug.

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Compounding Approach Steps

Pre-formulation, references, and formulation design.

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Bioavailability Objective

The drug must be bioavailable to exert its effects.

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Stability Objective

The product must be reasonably stable.

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Compliance Objective

The product design must encourage patient compliance.

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Marketing Objective

Commercial viability influences dosage form design.

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Administration Device

Materials and equipment necessary for drug delivery.

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Adsorbent (Excipient)

A substance that keeps powders dry.

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Antioxidant (Excipient)

A substance that prevents oxidation.

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Binders (Excipient)

Substances that hold powders/ingredients together.

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Coatings (Excipient)

Substances selected to prevent degradation.

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Flavoring agent (Excipient)

Substance to mask poor taste.

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Humectant (Excipient)

A substance that prevents preparations from becoming brittle.

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Lubricant/ Anti-adherent (Excipient)

Helps to keep ingredients from sticking to each other.

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Preservatives (Excipient)

Substances that prevent the growth of bacteria.

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Coarse Surface Use

Using a mortar and pestle with a rough surface.

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Smooth Surface Use

Using a mortar and pestle with a smooth surface.

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Electronic Balance Leveling

Ensure accurate measurements.

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Pulverization by Intervention

Using a solvent to dissolve and evaporate when reducing particle size.

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Powder Application

Ease of administration for child and geriatrics.

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Capsule Application

Capsule that conceals unpalatable drug taste.

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Diluent (Filler)

A bulking agent to increase tablet size.

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Disintegrant

A substance that causes a tablet to swell and burst in solution.

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Lubricant

A waxy material used to enhance powder flow during manufacturing.

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Enteric Coating

Designed to resist dissolving in the stomach and dissolve in the intestines.

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Trituration

A dry grinding method to reduce particle size.

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Levigation

Reducing particle size with a wetting agent.

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Colored Lactose Use

Ensures even drug distribution in a powder mixture.

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Solids-Filled Capsules

Dosage forms containing powder, granules, other capsules, or tablets inside a shell.

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Minimum Weighable Quantity

This is the limit of the balance.

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Coloring Agent (Excipient)

A substance that provides color to the compounded product.

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Tablet Forms

Dosage forms that are uncoated, coated, chewable, sublingual, buccal, effervescent, or oral disintegrating.

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Bioavailability of a drug

The drug must be able to exert it's effect on the body.

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Compounding references

Using appropriate books, stability, and or commercial products to identify the drug.

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Particle size reduction

The process of reducing the size of particles.

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Why use Geometric mixing?

Ensures uniform drug distribution when mixing a small amount of drug with a large amount of excipient.

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Pre-formulation focus?

Drug properties such as solubility and stability.

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Weighing device considerations

The minimum quantity that can be accurately weighed on that device.

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Dry trituration

Using a mortar and pestle to grind dry powders.

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Types of compounded powders

When powder are for reconstitution, divided, or bulk.

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Tablets

Dosage forms that are uncoated, coated, chewable, sublingual, buccal, effervescent, or oral disintegrating. Applications vary based on type.

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Capsules

Solid-filled, liquid-filled, or semisolid-filled. Applications vary based on which.

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Powders

Powders for reconstitution, divided powders, or bulk powders. Water is often added to reconstitute

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Drug Properties Focus

Solubility and stability impacts drug action

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Packaging Considerations

According to use, characteristics, and stability.

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Geometric Mixing

Ensures uniform distribution

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Comminution

A device used for particle size reduction (mortar & pestle)

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Coarse Mortar Surface

To reduce the particle size of hard solids.

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Smooth Mortar Surface

For all other compounding applications.

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Electronic Balance Level

Ensure accurate measurements.

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Pediatric/Geriatric powders

Convenient administration form for children and the elderly.

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Reason reasonably stable

The stability of the product must be in compliance for dosage.

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Diluent

A substance that adds bulk to a formulation, making it easier to handle and administer

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Lubricant (in Tablet Manufacturing)

A waxy substance added to powder mixtures to improve flow during the manufacturing process

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Geometric Dilution

Used for small amounts of potent drugs to ensure even distribution

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Solubility and stability

Pre-formulation drug characteristic to determine best delivery method

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Bioavailability

Drugs must be able to exert their effect on the body.

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Pulverizing Intervention

Using a solvent to dissolve and evaporate when reducing particle size.

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Compounded Powders

Powder that are made for reconstitution, divided, bulk powders

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Study Notes

Solids Dosage Forms

  • Solid dosage forms include tablets, capsules, and powders.
  • Tablets can be uncoated, coated (functional and non-functional), chewable, sublingual, buccal, effervescent, or oral disintegrating.
  • Capsules can be solid-filled, liquid-filled, or semisolid-filled.
  • Powders can be for reconstitution, divided, or bulk.

Common Compounded Solids

  • Tablets are typically molded or compressed, and capsules are solid-filled or liquid-filled.
  • Powders are divided or dispensed in bulk.

Compounding Approach

  • Pre-formulation involves understanding the drug's properties, particularly solubility and stability.
  • References include reference books, acceptable formulations with stability data, and commercial products.
  • Formulation design is a key step in the compounding process.

Dosage Form Fundamentals Objectives

  • Bioavailability is necessary for the drug to exert its pharmacologic effect.
  • Stability ensures the product remains usable throughout its shelf life.
  • Compliance is achieved by formulating the product in a way that encourages patient adherence.
  • Marketing considerations affect dosage form design, including patents and trademarks.

Dosage Form Fundamentals Composition

  • Active Pharmaceutical Ingredient (API) is the active drug substance.
  • Excipients support the absorption or stability of the API or are needed for manufacturing.
  • Packaging protects the dosage form's integrity.
  • An administration device may be necessary for drug delivery.

API properties

  • The source can be a pure drug, a modified salt form (HCl), or a commercial product (capsule, extended release, delayed release).
  • Strength of the drug can be available in high and low dosages with appropriate ingredients.

Excipients

  • Adsorbents like magnesium oxide/carbonate keep powders dry.
  • Antioxidants prevent oxidation, examples including ascorbic acid.
  • Binders such as acacia hold powders together.
  • Coatings (regular) like shellac prevent degradation.
  • Coloring agents like FD&C Red No. 3 provide color.
  • Diluents (filler) such as starches add size to small dosages.
  • Disintegrants like alginic acid cause tablets to swell and burst.
  • Enteric coatings like shellac prevent dissolution in the stomach.
  • Flavoring agents such as mannitol mask bitter flavors.
  • Humectants like glycerin prevent preparations from becoming brittle.
  • Lubricants such as magnesium stearate help prevent ingredients from sticking.
  • Preservatives like sodium benzoate prevent microbial growth.

Packaging and Administration

  • Packaging should suit the drug's use and its characteristics.
  • Administration devices include measuring devices for bulk powders.

Compounding Techniques and Equipment

  • Mortar and pestle with a coarse surface are used for particle size reduction of hard solids (crystalline), and emulsion formulation.
  • A smooth surface mortar and pestle is suitable for all other applications.
  • Avoid drug loss in mortar, especially with potent drugs.
  • Spatulas can be metal or rubber.
  • Weighing devices: Minimum weighable quantity (LWQ) on electronic balances in the lab: 40mg, plus leveling and tare usage.
  • Particle size reduction via trituration (dry), levigation (wet), pulverization, or mechanical methods.
  • Geometric mixing ensures uniform distribution of substances.

Solid Dosage Forms - Tablets

  • Tablets are the most frequently prescribed dosage form.
  • Tablets are convenient for handling, identification, and administration.
  • Tablets are easy to prepare and are made at a rate of thousands per minute.
  • Tablets are only available in fixed dosage strengths, with few compounded.
  • Store tablets at room temperature and are labeled with the mode of administration.
  • Tablet types include uncoated, coated, chewable, sublingual, buccal, effervescent, and oral disintegrating tablets.

Tablet Formulation

  • Drug (Active Pharmaceutical Ingredient).
  • Diluent (Filler) which adds bulk for appropriate tablet size.
  • Binder (“Glue”) that holds the tablet together.
  • Disintegrant, which is a swelling agent to facilitate dissolution and bioavailability.
  • Lubricant, which is waxy material for powder flow in manufacturing.

Solid Dosage Forms - Powders

  • Powders are thorough mixtures of dry, finely divided drugs and excipients for internal and external use.
  • Advantageous for pediatric and geriatric patients who have difficulty swallowing.
  • The quantity of medication can easily be altered.
  • Have a rapid onset of action.
  • Should not be used for drugs with a disagreeable taste or caustic in nature.
  • Powders have uniform and small particle size.
  • They are more stable than liquid dosage forms and are rapidly soluble and absorbed.
  • Divided powders and bulk powders are common compounded forms.
  • Bulk powders require patients to measure the desired quantity of each dose and measure large SA exposed to atmospheric conditions.
  • Large particles that are more dense tend to settle more rapidly than small particles.

Powder Calculations

  • To prepare Captopril powder 3 mg/dose #10, with instructions to administer 1 packet to child in food daily.
  • Use commercial tablets containing 12.5 mg captopril, 12.5 mg captopril + 47.5 mg excipients.

Solid Dosage Forms - Capsules

  • Capsules are dosage forms in which unit doses of powder, semisolid, or liquid drugs are enclosed in either a hard or soft shell.
  • Solids-filled, powder-filled, granule-filled, capsule within a capsule, tablet within a capsule, liquid-filled and semisolid-filled.
  • Capsules are the most versatile of all dosage forms.
  • Capsules are amenable to small-scale compounding by a pharmacist and provide dosing flexibility.
  • Capsules are available in different sizes, shapes, and colors, and can conceal unpalatable drug taste.
  • Calibrate capsules (select capsule size) using the punch method, and fill with lactose and weigh.
  • Capsules are stored based on the characteristics of the drug they contain and are stable, for protection from moisture and heat.

Considerations for Pharmaceutical Solids and Solid Compounding

  • Use proper equipment such as glass or porcelain mortar and pestle.
  • Ensure electronic balance is levelled and tared.
  • Ensure proper storage in appropriate temperature.
  • Use correct ingredients and calculations, and accurate capsule calibration.
  • Use geometric mixing and pack capsule using white bond paper.
  • Weigh each capsule and dispense in the proper container.

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Description

Explore solid dosage forms like tablets, capsules, and powders. Learn about pre-formulation, drug properties, and formulation design. Understand bioavailability and stability for effective compounding.

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