Pharmaceutical Tablet Formulation

Questions and Answers

What is the main purpose of lubricants in tablet formulation?

To prevent tablets from sticking together (correct)

To improve the flowability of the powder during tablet compression

To increase the mechanical strength of the tablet

To prevent the tablet from dissolving too quickly in the stomach

Which of the following compounds can act as both a glidant and a lubricant?

Stearic acid

Talc (correct)

Starch (correct)

Magnesium stearate

What is the primary function of tablet coatings?

To protect the tablet from the environment (correct)

To enhance the stability of the active ingredient

To improve the taste of the tablet

To increase the dissolution rate of the tablet

Which of the following is NOT a benefit of tablet coatings?

Increasing the bioavailability of the active ingredient Signup and view all the answers

What type of coating is used to delay the release of the active ingredient in the stomach?

Enteric coating Signup and view all the answers

Which of the following materials is commonly used in film coating?

Cellulose acetate phthalate Signup and view all the answers

What is the main purpose of coloring agents in tablet formulation?

To improve acceptability to patients and prevent counterfeiting Signup and view all the answers

What is the primary source of coloring agents in tablet formulation?

Synthetic dyes Signup and view all the answers

Which of the following is NOT a potential benefit of coloring agents in tablet formulation?

Enhanced bioavailability of the active ingredient Signup and view all the answers

What is the name of the authorization given by the European Medicines Agency for a drug?

Conditional Marketing Authorization Signup and view all the answers

What is the oldest source of drugs?

Plants Signup and view all the answers

What is a common use for cod liver?

Source of vitamins A and D Signup and view all the answers

Which of these is NOT a part of a plant that can be used as a source of drugs?

Bones Signup and view all the answers

What is the name of the agency in Australia that provides a Provisional Pathway for drug approval?

Australia Therapeutic Goods Administration Signup and view all the answers

What is the name of the authorization given by the China National Medicinal Products Administration for a drug?

Emergency Use Authorization Signup and view all the answers

What is a common use for zinc?

Zinc supplement Signup and view all the answers

What is the name of the agency in Japan that provides a Conditional Early Approval System for drug approval?

Japan Pharmaceuticals and Medical Devices Agency Signup and view all the answers

What is the name of the agency in the US that provides an Emergency Use Authorization for a drug?

US Food and Drug Administration Signup and view all the answers

What is the primary goal of the risk-based procedure outlined in the text?

To accelerate the availability of potentially life-saving treatments during public health emergencies Signup and view all the answers

What type of data is considered essential for evaluating unlicenced vaccines and therapies under this procedure?

All available data, including phase 1 and 2 studies, and a portion of phase 3 data Signup and view all the answers

What is the minimum number of recipients required for the phase 3 safety database?

3,000 Signup and view all the answers

What is a key example of a treatment mentioned in the text that could be evaluated under this risk-based procedure?

Anti-SARS-CoV-2 monoclonal antibodies Signup and view all the answers

What is one of the four statutory criteria for granting an EUA for an unlicenced treatment?

The potential benefits of the treatment must outweigh the potential risks Signup and view all the answers

What is the primary purpose of the four statutory criteria for granting an EUA?

To protect the public from potentially harmful treatments Signup and view all the answers

What type of illness is typically addressed by an EUA for an unlicenced treatment?

Serious or life-threatening illnesses Signup and view all the answers

What is the main advantage of using an EUA for unlicenced treatments during a public health emergency?

It allows for quicker access to potentially life-saving treatments Signup and view all the answers

What is the purpose of the requirement that "it must be reasonable to believe that the product covered by the EUA is going to be effective for the intended use"?

To ensure that the treatment is likely to be beneficial to the patient in the specific emergency situation Signup and view all the answers

What distinguishes pastes from ointments?

Pastes contain larger amounts of solids. Signup and view all the answers

What is the primary use of poultices?

To reduce inflammation and pain. Signup and view all the answers

Which of the following is an example of eye drops?

Chloramphenicol eye drops. Signup and view all the answers

What characterizes ear drops?

They are liquid preparations instilled into the ear. Signup and view all the answers

What is a common property of mouth washes?

They are concentrated with deodorant and antiseptic properties. Signup and view all the answers

What distinguishes lozenges from other forms of medication?

They are solid dosage forms designed for slow dissolution in the mouth. Signup and view all the answers

What is the primary purpose of paints in medical applications?

To leave a dry film of medicine on the skin or mucous membranes. Signup and view all the answers

What type of products are pessaries?

Solid bodies for vaginal administration of drugs. Signup and view all the answers

What type of solutions do eye lotions represent?

Solutions used for washing or bathing the eye. Signup and view all the answers

What is the primary focus of toxicology?

Examining adverse effects of drugs on the body Signup and view all the answers

Which factor does posology NOT depend on?

Drug interactions Signup and view all the answers

What is pharmacogenetics primarily concerned with?

Genetic variations affecting drug responses Signup and view all the answers

Which branch of health economics quantifies the cost and benefit of therapeutic drugs?

Pharmacoeconomics Signup and view all the answers

What does the study of drug interactions primarily investigate?

How drugs affect each other Signup and view all the answers

Which component is essential for rational prescribing?

Determining the appropriate route of administration Signup and view all the answers

What does experimental pharmacology utilize to assess drug efficacy?

Bioassay techniques and testing Signup and view all the answers

What is a fundamental criterion that defines toxicology?

The dose of the chemical substance Signup and view all the answers

What does pharmacoepidemiology study?

The effects of drugs on massive populations Signup and view all the answers

Study Notes

Tablet Ingredients and Functions

Anti-caking agents, like stearic acid and magnesium stearate, are used as lubricants; they can slow disintegration and dissolution.
Glidants and lubricants have differing properties; some compounds, such as starch and talc, exhibit both actions.
Tablet coatings protect against environmental factors (air, light, moisture) and enhance mechanical strength; sugar has been replaced by film coatings made from natural or synthetic polymers.
Polymers that resist acid, e.g., cellulose acetate phthalate, are utilized for enteric coatings to delay active ingredient release and may include flavors and colorings.

Antibiotics and Anti-neoplastics

Antibiotics are specialized medications used to treat bacterial infections.
Anti-neoplastic agents target cancer cells, inhibiting their growth and division.

Toxicology

Focuses on the adverse effects of drugs on the body, including symptoms, mechanisms, treatment, and detection of poisoning.
Dose is a critical factor; essential medicines can become poisons at high doses, and some poisons can serve as essential medicines at low doses.

Drug Interactions

Examines how different drugs affect each other when administered together.

Rational Prescribing

Emphasizes the importance of selecting the right medicine, dose, route, frequency of administration, and duration of treatment.

Pharmacoeconomics

A subfield of health economics that quantifies the costs and benefits of therapeutically used drugs.

Experimental Pharmacology

Involves studying pharmacology through bioassays to determine the efficacy and potency of drugs.

Posology

Studies how medicines are dosed based on various factors such as age, weight, sex, elimination rate, genetic polymorphism, and timing of administration.

Pharmacogenetics

Explores genetic variations that lead to different drug responses among individuals or populations.

Pharmacoepidemiology

Investigates the effects of drugs on large populations to assess health outcomes.

Emergency Use Authorization (EUA)

A risk-based procedure for evaluating unlicensed vaccines and therapeutics during public health emergencies.
Aims to expedite availability to affected individuals based on safety, efficacy, and quality data.
Safety data must include Phase 1 and 2 results, along with a portion of Phase 3 data with at least 2 months of median follow-up.

EUA Criteria

Requires serious or life-threatening illness from specific agents, lack of adequate alternatives, known benefits that outweigh risks, and reasonable belief in efficacy for the intended use.

International Mechanisms Similar to EUA

FDA (U.S.) - EUA
National Medical Products Administration (China) - EUA
European Medicines Agency - Conditional Marketing Authorization
Therapeutic Goods Administration (Australia) - Provisional Pathway
Pharmaceuticals and Medical Devices Agency (Japan) - Conditional Early Approval System

Drug Sources

Plant sources (e.g., alkaloids) have historically been prime drug sources, derived from leaves, flowers, fruits, seeds, roots, bark, and stems.
Animal sources include sheep thyroid for thyroxine, cod liver for vitamins A and D, and pituitary glands for gonadotropins in infertility treatments.
Mineral sources provide essentials like iron for anemia, zinc supplements, and iodine as an antiseptic.

Examples of Formulations

Pastes: Thicker than ointments, for topical application; may contain one or more drug substances.
Poultices: Externally applied thick pasty preparations to reduce inflammation and pain.
Dusting Powder: Finely powdered mixtures for external use, not on open wounds.
Eye Drops: Sterile solutions for instillation, containing various beneficial properties.
Lozenges: Solid forms for slow dissolution in the mouth, typically flavored.
Gargles: Concentrated aqueous solutions used for throat infections.
Mouthwashes: Antiseptic solutions with local analgesic properties, discarded after rinsing.
Pessaries: Solid forms for vaginal administration, such as nystatin pessaries.

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Description

Test your knowledge of tablet formulation, including the role of lubricants, glidants, and coatings in pharmaceutical manufacturing.