48 Questions
What is the definition of New Molecular Entity (NME) according to the FDA?
An active ingredient that has never before been marketed in the US
What is the purpose of excipients in a dosage form?
To conceal offensive taste and protect from environmental influence
What is the role of Drug Delivery System in drug administration?
To provide a mechanism for safe and convenient drug delivery
What is the main characteristic of a finished dosage form?
It contains the active ingredient in association with one or more other ingredients
What is a key advantage of liquid dosage form solutions?
Completely homogenous doses
What is a general rule in preparing solutions?
Choose the proper solvent the salt form of the drug is used
What is the purpose of Bacteriostatic Water for Injection (BWI)?
To prevent microbial growth in the water
What is the main difference between Water for Injection and Sterile Water for Injection?
Presence of antimicrobial agents
What is the purpose of adding the aqueous solution to the alcoholic solution when using an alcoholic solution of a purely water-soluble drug?
To prevent precipitation of the drug
What is the suitable pH range for Purified Water used in prescription and manufactured finished products?
5-7
When adding salt to syrup, what is the recommended initial step?
Dissolve salt in a few ml of water
What is the definition of an orphan drug?
A drug for rare diseases affecting fewer than 200,000 people in the US
What is the difference between in vitro and in vivo tests?
In vitro tests are bioassays outside the organism, while in vivo tests are conducted in living organisms
What are granules in relation to powder dosage forms?
Prepared agglomerates of smaller powder particles passed through sieves
What is the purpose of using a mortar and pestle in pharmaceutical preparation?
For suspension, solution, and ointment preparation
What does a treatment IND permit?
Use of investigational drugs for serious or life-threatening diseases
What is the content of the Papyrus Ebers?
Over 800 early drug formulas and prescriptions
Which method is NOT used in the manufacture of tablets?
Centrifugal compression
What is the primary component of gelatin capsules?
Gelatin
Which method is NOT utilized in transdermal drug delivery systems (TDDS)?
Hydrogel application
What is a commonly used base for rectal suppositories?
Cocoa butter
What is the ratio of citric acid monohydrate to tartaric acid in effervescent powders?
1:2
Which of the following is NOT a type of tablet?
Liquid-filled
What are the criteria for satisfactory suppository bases?
Inertness, firmness, rapid dissolution
Which of the following best describes the purpose of a drug delivery system?
Uniform release or targeting of drugs into the body
What is the primary role of finished dosage forms?
Provide therapeutic amount of drug to the proper site in the body promptly
Which phase of clinical trials involves long-term animal toxicity studies?
Phase 1
What is the main purpose of a dosage form?
Uniform release of drugs into the body
What is the primary function of a lead compound in drug development?
To provide a reference for the desired biological activity
What is the primary purpose of a treatment IND?
To allow use of investigational drugs for serious or life-threatening diseases
What are granules in relation to powder dosage forms?
Agglomerates of smaller powder particles passed through sieves
What is the primary purpose of using a mortar and pestle in pharmaceutical preparation?
To prepare suspensions, solutions, and ointments
What is the purpose of automatic devices for self-injecting drugs like Valium?
To facilitate convenient administration for patients
What is the primary use of Selsun Blue?
As a medicated shampoo
What is the primary function of Sterile Water for Injection?
To prepare parenteral solutions
What is the main characteristic of Bacteriostatic Water for Injection?
Contains one or more antimicrobial agents
What is the primary advantage of using a liquid dosage form solution?
Completely homogenous doses
What is the role of Water for Injection in pharmaceutical preparations?
Used for the preparation of parenteral solutions
What is the purpose of using the salt form of the drug in preparing solutions?
To enhance the drug's solubility
What defines Purified Water used in prescription and manufactured finished products?
Obtained by distillation, ion-exchange or reverse osmosis with a pH of 5-7
What is the primary function of effervescent powders?
Reacting with sodium bicarbonate to produce CO2
What is the primary component of gelatin capsules?
Collagen obtained from animal skin, connective tissues, and bones
What is the primary function of suppositories as a solid dosage form?
Intended for insertion into body orifices, useful in specific patient populations
What is the primary source of collagen for making gelatin capsules?
Animal skin, connective tissues, and bones
Which method is NOT utilized in the manufacture of tablets?
Centrifugal separation
What is the primary purpose of transdermal drug delivery systems (TDDS)?
To enhance drug diffusion through the skin
What is a key characteristic of suppositories as a solid dosage form?
Intended for insertion into body orifices
Which criterion is NOT considered for satisfactory suppository bases?
High drug solubility
Study Notes
Pharmaceutical Dosage Forms and Delivery Systems Overview
- Effervescent powders use citric acid monohydrate and tartaric acid in a 1:2 ratio, reacting with sodium bicarbonate to produce CO2.
- Gelatin capsules are made from collagen, obtained from animal skin, connective tissues, and bones, with different types and sizes available.
- Tablets are solid dosage forms primarily prepared by compression, offering advantages such as low manufacturing cost and easy swallowability, but may have limitations with certain drugs.
- Various methods of tablet manufacture include dry granulation, wet granulation, fluid bed processing, direct compression, and multiple-layered tablets.
- Different types of tablets, such as chewable, buccal, effervescent, sugar-coated, film-coated, and enteric-coated, cater to specific needs and preferences.
- Transdermal drug delivery systems (TDDS) utilize methods like electroporation, iontophoresis, phonophoresis, and high-velocity powder particles to enhance drug diffusion through the skin.
- Other solid dosage forms include lozenges, hypodermic tablets, pellets, cataplasm, plasters, transdermal patches, pills, bolus, dressing, and lollipops.
- Review questions cover topics ranging from the capacity of Capsule No.4 to the method of preparing hard gelatin capsules.
- TDDS enhanced by the application of short, high-voltage electric pulses, and other methods like iontophoresis and phonophoresis are used to facilitate drug diffusion.
- Suppositories, including rectal, vaginal, and urethral types, are solid dosage forms intended for insertion into body orifices, useful in specific patient populations.
- Criteria for satisfactory suppository bases include inertness, firmness, and rapid dissolution, with bases like fatty/oleaginous, water-soluble, and miscellaneous meeting these criteria.
- Cocoa butter is a good base for rectal suppositories, melting just below body temperature and maintaining solidity at room temperature. Different methods are used to prepare suppository bases, such as hand-rolling, compression, and fusion method.
Pharmaceutical Dosage Forms and Delivery Systems Overview
- Effervescent powders use citric acid monohydrate and tartaric acid in a 1:2 ratio, reacting with sodium bicarbonate to produce CO2.
- Gelatin capsules are made from collagen, obtained from animal skin, connective tissues, and bones, with different types and sizes available.
- Tablets are solid dosage forms primarily prepared by compression, offering advantages such as low manufacturing cost and easy swallowability, but may have limitations with certain drugs.
- Various methods of tablet manufacture include dry granulation, wet granulation, fluid bed processing, direct compression, and multiple-layered tablets.
- Different types of tablets, such as chewable, buccal, effervescent, sugar-coated, film-coated, and enteric-coated, cater to specific needs and preferences.
- Transdermal drug delivery systems (TDDS) utilize methods like electroporation, iontophoresis, phonophoresis, and high-velocity powder particles to enhance drug diffusion through the skin.
- Other solid dosage forms include lozenges, hypodermic tablets, pellets, cataplasm, plasters, transdermal patches, pills, bolus, dressing, and lollipops.
- Review questions cover topics ranging from the capacity of Capsule No.4 to the method of preparing hard gelatin capsules.
- TDDS enhanced by the application of short, high-voltage electric pulses, and other methods like iontophoresis and phonophoresis are used to facilitate drug diffusion.
- Suppositories, including rectal, vaginal, and urethral types, are solid dosage forms intended for insertion into body orifices, useful in specific patient populations.
- Criteria for satisfactory suppository bases include inertness, firmness, and rapid dissolution, with bases like fatty/oleaginous, water-soluble, and miscellaneous meeting these criteria.
- Cocoa butter is a good base for rectal suppositories, melting just below body temperature and maintaining solidity at room temperature. Different methods are used to prepare suppository bases, such as hand-rolling, compression, and fusion method.
Test your knowledge of pharmaceutical dosage forms and delivery systems with this overview quiz. Explore topics like tablet manufacture methods, types of tablets, transdermal drug delivery, and suppository bases. Perfect for pharmacy students and professionals looking to expand their understanding of pharmaceutical preparations.
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