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Questions and Answers
What is the definition of a drug substance?
What is the definition of a drug substance?
It is the unformulated drug substance that may subsequently be formulated with excipients to produce the dosage form.
What are the different types of solid dosage forms mentioned in the lecture?
What are the different types of solid dosage forms mentioned in the lecture?
What is the primary objective of dosage form design?
What is the primary objective of dosage form design?
To achieve a predictable therapeutic response to a drug included in a formulation which can be manufactured on a large scale with reproducible product quality.
Which of the following is NOT a general consideration for dosage form design?
Which of the following is NOT a general consideration for dosage form design?
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What are some examples of data that must be determined when designing a dosage form?
What are some examples of data that must be determined when designing a dosage form?
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For systemic use, tablets and/or capsules are preferred because they are easy to handle and administer.
For systemic use, tablets and/or capsules are preferred because they are easy to handle and administer.
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What is the definition of a drug product?
What is the definition of a drug product?
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What are excipients?
What are excipients?
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Why are excipients added to formulations?
Why are excipients added to formulations?
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What are the different types of excipients mentioned in the lecture?
What are the different types of excipients mentioned in the lecture?
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Which of the following is NOT a requirement for a suitable excipient?
Which of the following is NOT a requirement for a suitable excipient?
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Benzalkonium chloride is a preservative that can be used safely in nebulizer solutions.
Benzalkonium chloride is a preservative that can be used safely in nebulizer solutions.
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Excipients can influence the rate and extent of drug absorption.
Excipients can influence the rate and extent of drug absorption.
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What is a common example of a filler or bulking agent used in tablets and capsules?
What is a common example of a filler or bulking agent used in tablets and capsules?
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Why are surfactants often used in dosage forms?
Why are surfactants often used in dosage forms?
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What is the primary function of lubricants in tablet and capsule formulations?
What is the primary function of lubricants in tablet and capsule formulations?
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Magnesium stearate is a common lubricant used in tablet compaction and capsule filling.
Magnesium stearate is a common lubricant used in tablet compaction and capsule filling.
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What can be done to avoid the negative effect of magnesium stearate on dissolution rate?
What can be done to avoid the negative effect of magnesium stearate on dissolution rate?
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Disintegrants are required to break up tablets and capsules into particles to increase the surface area exposed to the gastrointestinal fluids.
Disintegrants are required to break up tablets and capsules into particles to increase the surface area exposed to the gastrointestinal fluids.
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A tablet that fails to disintegrate or disintegrates slowly may result in incomplete absorption or a delay in the onset of action of the drug.
A tablet that fails to disintegrate or disintegrates slowly may result in incomplete absorption or a delay in the onset of action of the drug.
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The compaction force used in tablet manufacture can affect disintegration.
The compaction force used in tablet manufacture can affect disintegration.
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What are the two classes of disintegrants mentioned in the lecture?
What are the two classes of disintegrants mentioned in the lecture?
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Which of the following is an example of a super disintegrant?
Which of the following is an example of a super disintegrant?
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Study Notes
Course Information
- Course Title: Pharmaceutics III
- Course Code: PIP 315
- Credit Hours: 3
- Instructor: Dr. Sally A. El-Zahaby
- Semester: Fall 2024-2025
- Program: Bachelor of Pharmacy –PharmD
Course Description
- The course covers kinetics of drug decomposition, including reaction rate, half-life and expiry/shelf-life determinations through testing.
- It explores in-vitro drug/excipient interactions.
- The course also describes the techniques for formulation and manufacturing of solids dosage forms including powders, granules, tablets, capsules, and suppositories.
Learning Outcomes
- List the different types of solid dosage forms (powders, granules, tablets, capsules, suppositories).
- Understand the reasons drugs are incorporated into various dosage forms.
- Understand the general considerations for dosage form design.
- List advantages and disadvantages of solid dosage forms.
- Identify excipients used in formulating solid dosage forms.
Definitions
- Drug Substance: The unformulated drug substance that will eventually be formulated into dosage forms utilizing excipients.
- Drug Substance (Active Pharmaceutical Ingredient - API): An agent employed in diagnosis, treatment, or prevention of diseases in humans or animals. Examples include pain reduction, fever reduction or blood pressure treatment.
- Dosage Forms: Pharmaceutical drug products meant for use; their form includes a specific mixture of active ingredients and inactive ingredients (excipients). -Dosage forms can be liquid, semi-solid or solid.
Solid Dosage Forms
- Powders
- Granules
- Tablets
- Capsules
- Suppositories -Note: Suppositories can also be classified as semi-solid dosage forms.
Reasons for Drug Incorporation into Dosage Forms
- Mask bitter, salty, or unpleasant tastes or odors (e.g., flavored syrups).
- Create liquid preparations, either dispersions (suspensions) or solutions.
- Deliver drugs to specific body orifices (e.g. rectal or vaginal suppositories).
- Protect drugs from atmospheric oxygen or humidity (e.g., enteric-coated tablets).
- Protect drugs from gastric acid (e.g., enteric-coated tablets).
General Considerations for Dosage Form Design
- The primary goal is predictable therapeutic responses from a manufactured product with reproducible quality.
- Quality assurance elements:
- Chemical and physical stability, with microbial preservation if needed.
- Uniform dosage of drug.
- Patient acceptability and suitable packaging/labeling.
- Data is necessary to form certain dosage forms. This includes route of administration, age of patient, existing medical conditions, and states of illness to be considered.
- For example, in emergencies where patients are unconscious or unable to swallow medication, injectable dosage forms will be used. In treatment of nausea and vomiting, suppositories and injections can be more efficient than oral dosage.
- For Infants and children under 5, pharmaceutical liquids are preferentially used over solid dosage forms in oral administration because of better handling. The solutions, syrups or suspensions will be flavored to increase acceptability.
Advantages of Solid Dosage forms
- High stability
- Ease of handling and transporting
- Smaller storage space
- More accurate dosing
Disadvantages of Solid Dosage Forms
- Difficulty swallowing (especially for children and elderly)
- Unconscious or intubated patients cannot adequately take solid dosage forms.
- Slower absorption compared to other dosage types
Dosage Forms
- A drug product is a dosage form packaged for marketing
- Drug products contain a drug substance and excipients.
- Excipients are anything else in the dosage form, not the drug itself.
Excipients
- Non-medicinal agents with specialized functions that enhance the effectiveness and appeal of dosage forms.
- Also known as "excipients" which are any materials not the drug.
- Added for ease of preparation, patient preference and functions within delivering the drug.
- Specific excipients depend on functions (e.g. solubility, suspension agents, preservation, flavorings, coloring, emulsifying, disintegrating agents, diluents, lubricants).
- Excipients must be both non-toxic, nonirritating and compatible with all formulations so the patient product is stable, effective, easy-to-administer and safe.
- Some excipients are suitable for certain purposes and less applicable for others (e.g., preservatives used in oral solutions may not be suitable for nebulizers).
- Excipients can affect bioavailability (e.g., poorly-soluble drug-excipient complexes).
Examples of Excipients
- Diluents/Fillers: (Like lactose) used when the drug is present in insufficient amounts to adequately create solid dosage forms.
- Surfactants: (Including emulsifying, solubilizing, wetting agents) enhance bioavailability of poorly-soluble drugs.
- Lubricants: (Like Magnesium stearate) reduce friction during manufacture of tablets and capsules.
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Disintegrants: Substances that promote the breakdown of tablets or capsules into fine particles to increase absorption area in the gastrointestinal tract.
- Types: traditional (e.g., starch) and super disintegrants (e.g., croscarmellose sodium, crospovidone, sodium starch glycolate)
- There is also a mention of a video about tablet machines
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Description
Test your knowledge on solid dosage forms, including powders, granules, tablets, capsules, and suppositories, in the Pharmaceutics III course. This quiz will cover drug decomposition kinetics, formulation techniques, and the interactions of drugs with excipients. Challenge yourself and reinforce your understanding of key concepts in drug formulation.
