Industrial Pharmacy II - Lecture 2
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Questions and Answers

What is a pharmaceutical dosage form defined as?

A combination of drug (active pharmaceutical ingredient (API)) and excipients in a certain configuration.

What is the role of the drug in a pharmaceutical dosage form?

The active pharmaceutical material that can alter the biological condition.

What are excipients?

Inactive materials that do various actions during manufacturing, storage, and use of formulations.

Which of these is an advantage of pharmaceutical dosage forms?

<p>Both A and B.</p> Signup and view all the answers

How are dosage forms classified based on their route of delivery?

<p>All of the above.</p> Signup and view all the answers

How are dosage forms classified based on their physical form?

<p>All of the above.</p> Signup and view all the answers

What is the purpose of the pre-formulation stage in manufacturing a dosage form?

<p>To identify physical and chemical properties of the medicinal substance which will indicate the efficacy and bioavailability of the candidate dosage form.</p> Signup and view all the answers

What are some factors evaluated during the pre-formulation stage?

<p>All of the above.</p> Signup and view all the answers

What is the goal of biopharmaceutical studies in dosage form manufacturing?

<p>To discover the rate and extent at which candidate drug will be available at the site of action.</p> Signup and view all the answers

Which of these is NOT a biopharmaceutical study?

<p>Formulation and development</p> Signup and view all the answers

What is the main purpose of pharmacodynamic studies?

<p>To study the effect of the drug on the body, including therapeutic effect, toxic effect, and adverse drug reaction.</p> Signup and view all the answers

What does pharmacokinetic studies investigate?

<p>The effect of the body on drug.</p> Signup and view all the answers

What is the focus of product analysis in dosage form manufacturing?

<p>To make several candidate dosage forms and test their bioavailability, pharmacokinetic properties, preferred dosage form, and required dose.</p> Signup and view all the answers

What additional factors are investigated besides bioavailability and pharmacokinetics in dosage form manufacturing?

<p>Patient compliance, cost of manufacturing, and stability of the final dosage form.</p> Signup and view all the answers

What is the main focus of the formulation and development stage in dosage form manufacturing?

<p>The actual formulation of the desired dosage form.</p> Signup and view all the answers

Why is the oral route considered the most important method of administering drugs for systemic effects?

<p>All of the above.</p> Signup and view all the answers

Tablet dosage forms are the only type of oral dosage forms available.

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

Tablets are always composed of only the API (Active Pharmaceutical Ingredient).

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

What factors can influence variations in tablet size, shape, weight, hardness, thickness, disintegration, and dissolution characteristics?

<p>Both A and B.</p> Signup and view all the answers

How are tablets typically prepared?

<p>By compression.</p> Signup and view all the answers

Which of these is an advantage of tablet dosage forms?

<p>All of the above.</p> Signup and view all the answers

Which of these is NOT a disadvantage of tablet dosage forms?

<p>Less likely to be mistaken for candy.</p> Signup and view all the answers

What type of tablet is designed for rapid disintegration?

<p>Compressed tablet (plain tablet)</p> Signup and view all the answers

Most tablets containing drugs intended for local GI effects are of the compressed tablet type.

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

Compressed tablets are only used for local GI effects.

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

What are the two classes of multiple compressed tablets?

<p>Both A and B.</p> Signup and view all the answers

Multiple compressed tablets contain only one component.

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

What is the main reason for preparing a tablet using multiple compression?

<p>To separate physically or chemically incompatible ingredients or to produce multiple or prolonged action products.</p> Signup and view all the answers

What is a drawback of multiple compressed tablets?

<p>Both A and B.</p> Signup and view all the answers

Multiple compressed tablets are commonly marketed due to their numerous advantages.

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

What is the main purpose of chewable tablets?

<p>To be chewed in the mouth before ingestion and are not intended to be swallowed intact.</p> Signup and view all the answers

Chewable tablets are only used for children.

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

Bitter or foul-tasting drugs are ideal candidates for chewable tablets.

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

What is the advantage of chewable tablets for antacids?

<p>They provide two advantages: the dose of most antacids is large, so a chewable tablet is better for patient compliance; and, the activity of the antacid is related to its particle size, so chewing the tablet prior to swallowing may improve acid neutralization.</p> Signup and view all the answers

What is the purpose of sugar-coated tablets?

<p>Sugar coating enhances the tablet's aesthetic appeal and masks unpleasant flavors.</p> Signup and view all the answers

What is TRUE about the coating in sugar-coated tablets?

<p>All of the above.</p> Signup and view all the answers

What is an example of a sugar-coated tablet?

<p>Flu-out® tablet</p> Signup and view all the answers

What is the main purpose of film-coated tablets?

<p>Developed as an alternative way for enteric and sugar coating, producing an elegant tablet and offering some control of the drug release profile.</p> Signup and view all the answers

What is an advantage of film-coated tablets over sugar-coated tablets?

<p>All of the above.</p> Signup and view all the answers

Film-coated tablets are as elegant and shiny as sugar-coated tablets.

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

What type of tablet is designed to provide extended drug release?

<p>Repeated action tablets</p> Signup and view all the answers

Repeated action tablets are a specific type of multiple compressed tablets.

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

What is an example of a drug commonly formulated as a repeated action tablet?

<p>Some antiallergic medications.</p> Signup and view all the answers

What is the main purpose of delayed action and enteric-coated tablets?

<p>To protect the stomach from irritation caused by some medications, such as aspirin.</p> Signup and view all the answers

Delayed action tablets are only used for drugs that irritate the stomach.

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

What is a commonly used material for enteric-coated tablets?

<p>Cellulose acetate phthalate.</p> Signup and view all the answers

Where are buccal and sublingual tablets designed to dissolve and release their active component?

<p>The oral cavity.</p> Signup and view all the answers

Buccal and sublingual tablets are absorbed via the gastrointestinal tract.

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

Buccal and sublingual tablets avoid first-pass metabolism.

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

What is an example of a drug commonly administered as a buccal or sublingual tablet?

<p>Nitroglycerine tablet.</p> Signup and view all the answers

Where do troches and lozenges exert their effect?

<p>The mouth or throat.</p> Signup and view all the answers

Troches and lozenges are prepared by compression like most tablets.

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

Troches and lozenges are designed to disintegrate rapidly in the mouth.

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

What is the purpose of dental cones?

<p>Designed to be placed in empty space after tooth extraction, providing slower releasing antibacterial agent or to reduce bleeding.</p> Signup and view all the answers

What type of tablet is designed for subcutaneous implantation and sustained drug release?

<p>Implantation tablets.</p> Signup and view all the answers

Implantation tablets are typically more than 8 mm in length.

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

Implantation tablets can be administered orally.

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

What is the purpose of vaginal tablets?

<p>To undergo slow dissolution and drug release in the vaginal cavity.</p> Signup and view all the answers

Vaginal tablets are always round in shape.

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

What is the purpose of effervescent tablets?

<p>All of the above.</p> Signup and view all the answers

What is a disadvantage of effervescent tablets?

<p>They are relatively complicated to manufacture and store.</p> Signup and view all the answers

What was the main purpose of dispensing tablets?

<p>All of the above.</p> Signup and view all the answers

Dispensing tablets are still commonly used today.

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

What type of drug are hypodermic tablets designed to contain?

<p>Water-soluble drugs.</p> Signup and view all the answers

Hypodermic tablets are still used for preparing solutions for injection.

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

What are tablet triturates?

<p>Tablets prepared by the pharmacist using a potent drug.</p> Signup and view all the answers

Tablet triturates are widely used in modern pharmacy practice.

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

What qualities should an ideal tablet possess?

<p>All of the above.</p> Signup and view all the answers

What are some properties of tablet ingredients?

<p>All of the above.</p> Signup and view all the answers

What is the role of an antioxidant in tablet formulations?

<p>To inhibit oxidation and prevent deterioration of preparations by oxidative processes.</p> Signup and view all the answers

What is the purpose of a tablet anti-adherent?

<p>To prevent the sticking of tablet formulation ingredients to punches and dies during tablet production.</p> Signup and view all the answers

What is the role of a tablet binder?

<p>To cause adhesion of powder particles in tablet granulations.</p> Signup and view all the answers

What is the function of a tablet diluent?

<p>To create desired bulk, flow properties, and compression characteristics in the preparation of tablets.</p> Signup and view all the answers

What is the main purpose of a tablet disintegrant?

<p>To promote disruption of solid mass into smaller particles which are more readily dispersed or dissolved.</p> Signup and view all the answers

What is the function of a tablet glidant?

<p>To improve the flow properties of powder mixture in tablet and capsule formulations.</p> Signup and view all the answers

What is the role of a tablet lubricant?

<p>To reduce friction during tablet compression.</p> Signup and view all the answers

Study Notes

Industrial Pharmacy II - Lecture Notes

  • Lecture 2: Focuses on pharmaceutical dosage forms, their classification, manufacturing stages, tablet dosage forms, advantages and disadvantages of tablets, types of tablets, and tablets used in the oral cavity.

What is Pharmaceutical Dosage Form

  • Defined as a combination of drug (API) and excipients in a specific configuration.
  • Drug is the active pharmaceutical ingredient that alters biological conditions.
  • Excipients are inactive materials involved in manufacturing, storage, and formulation use.
  • Advantages of dosage forms include delivering the right amount of drug conveniently and acceptably to patients.
  • Dosage forms enable control of drug delivery (e.g., fast-onset, extended-release).

Classification of Dosage Forms

  • Based on Route of Delivery: Pulmonary, Parenteral, Transdermal, Nasal, Ophthalmic, Otic, Vaginal, Rectal, Oral.
  • Based on Physical Form: Solid, Semisolids, Liquid, Gaseous.

Stages of Manufacturing a Dosage Form

  • Pre-formulation Stage: Preliminary studies to identify the physical and chemical properties of the medicinal substance to determine efficacy and bioavailability of the candidate dosage form.
  • Evaluation of particle size, solubility, stability, excipient compatibility, and crystal/surface properties.
  • Biopharmaceutical Studies: Discover the rate and extent at which candidate drug will be available at the site of action (includes pharmacodynamic, pharmacokinetic, and product analysis studies).
  • Formulation and Development: Involve the actual formulation of the desired dosage form. Other studies include patient compliance, cost of manufacturing, and stability analysis.

Tablet Dosage Form

  • Oral route is the most important method of administering drugs for systemic effects.
  • About 90% of drugs are administered orally.
  • Tablets are the most common form of orally administered dosage forms.
  • Tablets consist of API and excipients.
  • Characteristics can vary in size, shape, weight, hardness, thickness, disintegration, and dissolution.
  • Tablet preparation usually involves compression.

Advantages of Tablets

  • Unit dosage form: provides accurate dosage measurement.
  • Relatively lightweight and compact.
  • Easy to handle, store, and dispense.
  • Easier to package and ship than capsules.
  • Relatively inexpensive manufacturing cost.
  • Identification is generally simple.
  • Ease of swallowing
  • Good for large scale production
  • Good stability (chemical, mechanical, microbiological).
  • Easy to control and manipulate drug release

Disadvantages of Tablets

  • Some drugs resist compression into a dense compact.
  • Not ideal for masking bad tastes or smells.
  • Can be difficult for drugs with poor wetting properties and slow dissolution rates.
  • Some drugs may degrade when administered orally.

Types of Tablets

  • Compressed tablets (plain tablets): Uncoated tablets designed for rapid disintegration and drug release. Intended for local GI effects (antacids, adsorbents), and systemic circulation (e.g., ibuprofen).
  • Multiple compressed tablets: Layered tablets or compression-coated tablets. Contain two or more components separated and are intended to separate physically or chemically incompatible ingredients, or create multiple or prolonged action products.
  • Drawbacks of Multiple compressed tablets: slower production speed, difficult to control the release of each layer.
  • Chewable tablets: Designed to be chewed before swallowing, mainly used for children or those who struggle with swallowing. Excellent for masking bad taste or requiring larger doses.
  • Sugar-coated tablets: Sugar coating masks odor and taste, good for aesthetics, and dissolves quickly.
  • Film-coated tablets: Developed as an alternative to sugar coating, provides elegant appearance, sometimes better mechanical strength and sometimes modified-release properties.
  • Repeated-action tablets: One type of extended-release dosage form, designed for controlled release of medication over time (e.g., antiallergic medications)
  • Delayed action and enteric-coated tablets: Designed to protect the stomach from drug irritation, dissolve in the small or large intestine, coated by a shell that resists gastric acid dissolution. Preservation against stomach acid. (e.g., aspirin)
  • Buccal and sublingual tablets: Dissolve in the mouth, rapidly deliver medication to systemic circulation, via the oral mucosa, avoiding first-pass metabolism (e.g., nitroglycerin).
  • Troches and lozenges: Used in the mouth or throat, dissolve slowly (e.g., cough drops)
  • Dental cones: Used in tooth extraction sites, provide slower sustained release of antibacterial agent.

Tablets Used to Prepare Solutions

  • Effervescent tablets: Designed to create a solution by rapidly releasing carbon dioxide. Suitable for masking bad taste and are easy to adjust pH. Often contain citric acid and sodium bicarbonate.
  • Dispensing tablets: Used to create solutions for a specific concentration of other drugs.
  • Hypodermic tablets: Used to create injectable solutions.

Ideal Tablet Characteristics

  • Elegant appearance.
  • Resistance to physical damage.
  • Chemical and physical stability during shelf-life.
  • Predictable and reproducible release of the medicinal agent(s).
  • Suitable chemical stability.

Properties of Tablet Ingredients

  • Nontoxic: Be legal in the market area.
  • Commercially available
  • Reasonable cost
  • Must be physiologically inert
  • Stable in preparation (with other components).
  • Absence of contaminations.
  • Color compatibility (does not cause off-colors)
  • Non-alteration of bioavailability

Tablet Excipients

  • Antioxidants: Prevent drug deterioration.
  • Antiadherents: Prevent sticking.
  • Binders: Cause adhesion amongst particles.
  • Diluents: Fillers to achieve bulk.
  • Disintegrants: Promote disruption into smaller particles.
  • Glidants: Improve powder flow.
  • Lubricants: Reduce friction.

Tablets Administered by Other Routes

  • Implantation tablets: Designed for prolonged release of medication, usually subcutaneous.
  • Vaginal tablets: For vaginal use, slow dissolution and drug release in the vaginal cavity.

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Description

This quiz covers key concepts from Industrial Pharmacy II Lecture 2, focusing on pharmaceutical dosage forms. It explores their classification, manufacturing stages, and the advantages and disadvantages of various tablet dosage forms. Understand the roles of active pharmaceutical ingredients and excipients in drug delivery.

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