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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 active pharmaceutical material, or Drug, in a dosage form?

It can alter the biological condition.

What are Excipients?

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

What are the two key advantages of dosage forms?

Deliver the right amount of drug in a convenient way and enable control of drug delivery Signup and view all the answers

Which of the following are the two primary categories for classifying dosage forms?

Based on Route of Delivery Signup and view all the answers

What are the different categories for classifying dosage forms based on Route of Delivery? (Select all that apply)

Otic Signup and view all the answers

What are the categorizations for dosage forms based on Physical Form? (Select all that apply)

Solid Signup and view all the answers

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

Preliminary studies to identify the physical and chemical properties of the medicinal substance. Signup and view all the answers

What are the key aspects evaluated in the Pre-formulation stage? (Select all that apply)

Solubility Signup and view all the answers

What is the primary purpose of Biopharmaceutical studies?

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

What are the key aspects explored in Biopharmaceutical studies? (Select all that apply)

Pharmacokinetic Studies Signup and view all the answers

What is the focus of Pharmacodynamic studies?

The effect of the drug on the body; this includes therapeutic effect, toxic effect, and adverse drug reaction. Signup and view all the answers

What is the focus of Pharmacokinetic Studies, in contrast to pharmacodynamic studies?

Effect of the body on drug. Signup and view all the answers

What is the purpose of Product analysis in Biopharmaceutical studies?

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

What aspects are included in the 'Other studies' category of Biopharmaceutical investigations? (Select all that apply)

Cost of manufacturing Signup and view all the answers

What constitutes the Formulation and Development stage in the manufacturing of a dosage form?

The actual formulation of the desired dosage form. Signup and view all the answers

The Oral route is often considered the least important method for administering drugs that need systemic effects.

False Signup and view all the answers

What percentage, approximately, of drugs are administered orally?

90% Signup and view all the answers

The term 'Tablets' refers to the most common form of orally administered dosage form.

True Signup and view all the answers

What are the two key components of a Tablet, besides the drug?

API and excipients. Signup and view all the answers

What factors can contribute to the variation in the size, shape, weight, hardness, thickness, disintegration, and dissolution characteristics of tablets? (Select all that apply)

Method of manufacture Signup and view all the answers

How are Tablets typically prepared?

Prepared by compression Signup and view all the answers

What is the main advantage of Unit Dosage Form?

It provides an accurate dose. Signup and view all the answers

What is a key advantage of Tablets in regards to their size and weight?

They are the lightest and most compact of all oral dosage forms. Signup and view all the answers

Tablets are challenging to handle, store, and dispense in a tamperproof form.

False Signup and view all the answers

Tablets offer a distinct advantage over capsules in terms of ease of shipping and packaging.

True Signup and view all the answers

The manufacturing cost of Tablets is typically higher than most other dosage forms.

False Signup and view all the answers

What is a key advantage of Tablets in terms of identifiability?

Identification of tablets is potentially the simplest and cheapest. Signup and view all the answers

What is the potential disadvantage of Tablets in regards to swallowing?

They may provide the greatest ease of swallowing with the least tendency for "hang-up" above the stomach. Signup and view all the answers

Tablet disintegration should be excessively rapid to ensure proper absorption.

False Signup and view all the answers

Tablets are not suitable for large-scale production compared to other oral dosage forms.

False Signup and view all the answers

What key unique advantage do Tablets offer in terms of stability?

They have the best combine properties of chemical, mechanical, and microbiologic stability of all the oral forms. Signup and view all the answers

The release profile of Tablets is extremely difficult to control and manipulate.

False Signup and view all the answers

What is one disadvantage of Tablets related to their composition?

Some drugs resist compression into the dense compact. Signup and view all the answers

Tablets are ideal for masking the taste or smell of unpleasant drugs.

False Signup and view all the answers

What is a potential concern when using tablets with drugs sensitive to oxygen or moisture?

They may require encapsulation or entrapment prior to compression. Signup and view all the answers

Formulating tablets for drugs with poor wetting properties and slow dissolution properties is a straightforward process.

False Signup and view all the answers

The challenge of drug degradation if administered orally only applies to tablets.

False Signup and view all the answers

What are the two main classes of Multiple compressed tablets?

Compression-coated tablets Signup and view all the answers

Multiple compressed tablets contain only one component.

False Signup and view all the answers

How are Multiple compressed tablets formulated?

Formulated by light compression for each layer then a final full compression for the whole tablet. Signup and view all the answers

What is the main rationale for creating Multiple compressed tablets? (Select all that apply)

Separate physically or chemically incompatible ingredients Signup and view all the answers

The production speed of multiple compressed tablets is faster than compressed tablets; this is especially true for compression-coated tablets.

False Signup and view all the answers

It is relatively easy to control the release of each layer in Multiple compressed tablets.

False Signup and view all the answers

Multiple compressed tablets are commonly marketed and readily available.

False Signup and view all the answers

What is a crucial aspect of Chewable tablets?

To be chewed in the mouth before ingestion and not intended to be swallowed intact. Signup and view all the answers

For whom are Chewable tablets primarily designed?

Children and people who have difficulty swallowing the intact tablet. Signup and view all the answers

What is a potential drawback of Chewable tablets?

Bitter or foul-tasting drugs are not good candidates for this type of tablet. Signup and view all the answers

What are the two primary advantages of Chewable tablets in the context of antacid medication?

The dose of most antacids is large, and the activity of the antacid is related to its particle size. Signup and view all the answers

What is the primary purpose of the coating on Sugar-coated tablets?

To produce an elegant tablet and to hide the smell or taste of some medications. Signup and view all the answers

The coating on Sugar-coated tablets is not water-soluble.

False Signup and view all the answers

What is the alternative to Sugar-coated tablets and what are their key advantages?

Film-coated tablets; they produce an elegant tablet and offer some control of the drug release profile. Signup and view all the answers

What are the key advantages of Film-coated tablets over Sugar-coated tablets? (Select all that apply)

Shorter production time Signup and view all the answers

Film-coated tablets are often considered more elegant and shiny than Sugar-coated tablets.

False Signup and view all the answers

What type of tablet works by releasing each layer at a specific time?

Repeated action tablets. Signup and view all the answers

What are the common uses of Repeated action tablets? (Select all that apply)

Antiallergic medications Signup and view all the answers

What is the primary function of the shell in Delayed action and enteric-coated tablets?

To protect the stomach from irritation caused by some medications. Signup and view all the answers

Delayed action and enteric-coated tablets are not effective in protecting drugs from degradation by gastric acid.

False Signup and view all the answers

What common material is used in enteric-coated tablets?

Cellulose acetate phthalate. Signup and view all the answers

Buccal and sublingual tablets are the least common type within this category.

False Signup and view all the answers

What is the intended action of buccal and sublingual tablets?

To dissolve and release their active component rapidly. Signup and view all the answers

How do buccal and sublingual tablets achieve systemic circulation?

Drugs pass directly to the systemic circulation and avoid first-pass metabolism. Signup and view all the answers

Buccal and sublingual tablets are known for producing a slower onset of drug action.

False Signup and view all the answers

What is a common example of a buccal or sublingual tablet and its primary use?

Nitroglycerine tablet (angised®) for angina. Signup and view all the answers

Where are troches and lozenges intended to exert their effect?

In the mouth or throat. Signup and view all the answers

Troches are prepared by compression.

True Signup and view all the answers

What is a key characteristic of troches and lozenges in terms of disintegration?

They are not designed to disintegrate. Signup and view all the answers

What is the intended placement of Dental cones?

To be placed in an empty space after tooth extraction. Signup and view all the answers

What is the primary action of Dental cones?

Provides slower releasing antibacterial agent or to reduce bleeding. Signup and view all the answers

Implantation tablets are designed for oral administration for extended drug release.

False Signup and view all the answers

What is the route of administration for Implantation tablets?

Subcutaneous implantation. Signup and view all the answers

Implantation tablets are typically large in size and length.

False Signup and view all the answers

How is administration of Implantation tablets typically achieved?

Administered using a special syringe or may require a surgical procedure. Signup and view all the answers

What is the key property of Vaginal tablets regarding drug release?

Designed to undergo slow dissolution and drug release in the vaginal cavity. Signup and view all the answers

Vaginal tablets are typically spherical in shape.

False Signup and view all the answers

Vaginal tablets always come with an applicator.

True Signup and view all the answers

What is the main action of Effervescent tablets?

Designed to make solution rapidly with simultaneous release of carbon dioxide. Signup and view all the answers

What are the key components typically found in Effervescent tablets? (Select all that apply)

Sodium bicarbonate Signup and view all the answers

What are the main advantages of Effervescent tablets? (Select all that apply)

Provide an accurate dose. Signup and view all the answers

Effervescent tablets are simple and easy to manufacture and store.

False Signup and view all the answers

What is Dispensing tablets?

An old form of tablets that were used by the pharmacist to prepare a drug solution at a specific concentration. Signup and view all the answers

Dispensing tablets contain the same amount of active ingredient as other usual tablets.

False Signup and view all the answers

What is the primary intended use of Hypodermic tablets?

Contains water-soluble drugs that are designed to be added to sterile water to prepare a solution for injection. Signup and view all the answers

Hypodermic tablets are still widely used today.

False Signup and view all the answers

What is the primary function of Tablet triturates?

Tablets prepared by the pharmacist using a potent drug. Signup and view all the answers

Tablet triturates are a common dosage form used today.

False Signup and view all the answers

What characteristics are desirable for an Ideal Tablet? (Select all that apply)

Controlled drug release Signup and view all the answers

What qualities should tablet ingredients possess? (Select all that apply)

Affordable Signup and view all the answers

What is the role of Antioxidants in tablet formulations?

Agent that inhibits oxidation and thus is used to prevent deterioration of preparations by oxidative process. Signup and view all the answers

What is the function of Tablet anti-adherents?

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

What is the role of Tablet binders in tablet formulations?

Substance used to cause adhesion of powder particles in tablet granulations. Signup and view all the answers

What is the primary role of Tablet diluents in tablet formulations?

Inert substance used as filler to create desired bulk, flow properties, and compression characteristics in preparation of tablets. Signup and view all the answers

What is the purpose of Tablet disintegrants in tablet formulations?

Used in solid dosage forms to promote disruption of solid mass into smaller particles which are more readily dispersed or dissolved. Signup and view all the answers

What is the role of Tablet glidants in tablet formulations?

Agent used in tablet and capsule formulations to improve flow properties of powder mixture. Signup and view all the answers

What is the function of Tablet lubricants?

Substance used in tablet formulations to reduce friction during tablet compression. Signup and view all the answers

Study Notes

Industrial Pharmacy II - Lecture Notes

Definition of Pharmaceutical Dosage Form: A combination of drug (API) and excipients in a specific configuration. The drug is the active pharmaceutical ingredient, and excipients are inactive materials with various roles during manufacturing, storage, and use of formulations.

Classification of Dosage Forms

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

Stages in Manufacturing a Dosage Form

A- Pre-formulation Stage: Preliminary studies to identify physical and chemical properties of the medicinal substance, evaluate particle size, solubility, stability, excipient compatibility, and crystal/surface properties to determine efficacy and bioavailability.
B- Biopharmaceutical Studies: Discover the rate and extent at which candidate drug will be available at the site of action, including pharmacodynamic studies (effect of drug on body, including therapeutic effect, toxic effect, and adverse drug reactions), pharmacokinetic studies (effect of body on drug, including absorption, distribution, metabolism, and excretion), product analysis (create several candidate dosage forms and test bioavailability, pharmacokinetic profile, preferred dosage form, and required dose), and other studies for final dosage form including patient compliance, manufacturing cost, and stability.
C- Formulation and Development: Involves the actual formulation of the desired dosage form.

Tablet Dosage Form

Oral Route: Most important method of administering drugs for systemic effects, with ~90% of drugs administered orally. Tablets are the most common form of orally administered dosage forms. They consist of API and excipients.
Tablet Characteristics: Vary in size, shape, weight, hardness, thickness, disintegration, and dissolution characteristics which depend on their intended use and method of manufacture. Typically prepared by compression.

Advantages of Tablets

Unit Dosage Form: Accurate dose; easier to handle, store, and dispense; less chance of error in measurement than liquid forms; easier than capsules to ship/package; low manufacturing costs; simple and inexpensive identification through stamping/embossing.
Swallowing Ease: Greatest ease of swallowing with least tendency of "hang-up" above stomach (especially with coatings); suited to large-scale manufacturing; good chemical, mechanical, and microbiological stability.

Disadvantages of Tablets

Drug Compatibility: Some drugs resist compression into a dense compact due to their nature (amorphous or flocculent); not ideal for hiding bad taste/smell of some APIs (especially those sensitive to oxygen or moisture), requiring encapsulation or entrapment; difficult to create for drugs with poor wetting properties/slow dissolution.

Types of Tablets (Ingested Orally)

1. Compressed Tablets (Plain): Uncoated; rapid disintegration & drug release; intended for local GI effects (e.g., antacids, adsorbents); and systemic circulation (e.g., acidic drugs like ibuprofen).
2. Multiple Compressed Tablets: Layered / Compression-coated tablets containing two or more components separated from each other. Prepared by light compression for each layer, then final compression of entire tablet. Used to separate physically/chemically incompatible ingredients or produce multiple or prolonged action products. However, production speed is slower and releasing each layer in the gastrointestinal tract can be difficult to control.
3. Chewable Tablets: Designed to be chewed before swallowing. Primarily for children/people with swallowing difficulties; often used for antacids due to their large dose size. Drugs with bad taste/smell are usually not suited for this type.
4. Sugar-coated Tablets: Coated with a thin layer of sugar to improve appearance (color) and mask taste/smell of medication. Coating is water soluble and dissolves quickly after swallowing.
5. Film-coated Tablets: Developed as an alternative to sugar coating; good mechanical strength from polymer coating; avoids sugar as an excipient; continuous/semiautomated production allows for shorter production time; less chance of being mistaken for candy. However, not as elegant as sugar-coated.
6. Repeated/Extended Release Tablets: Specific type of multiple compressed tablets; designed for each layer to release its component at a specific time; examples are some antiallergic medications.
7. Delayed Action/Enteric-coated Tablets: This type of tablet is coated with a shell material that prevents dissolution in the stomach but dissolves in the small/large intestine releasing medicine. This is used to protect the stomach lining from irritation caused by medications. Cellulose acetate phthalate is a common shell material.
8. Buccal and Sublingual Tablets: Designed to dissolve in the oral cavity; release active ingredients rapidly in a small volume; absorbed directly into the systemic circulation, bypassing first-pass metabolism; used for rapid onset of drug action, e.g., nitroglycerin for angina.
9. Troches and Lozenges: Used in the oral cavity for throat relief; prepared by compression; meant to dissolve slowly in the mouth without disintegration.
10. Dental Cones: Minor tablet form placed in empty space after tooth extraction; slow release of antibacterial properties for bleeding control.

Tablets Administered by Other Routes

1. Implantation Tablets: Depot tablets for subcutaneous implantation, release product over a prolonged time; usually small and cylindric/rosette-shaped. Administered via a special syringe or surgical procedures.
2. Vaginal Tablets: Designed for slow dissolution and release in the vaginal cavity; oval in shape, usually delivered with an applicator.

Tablets Used to Prepare Solutions

1. Effervescent Tablets: Designed to dissolve rapidly and simultaneously release carbon dioxide; include citric acid and sodium bicarbonate; highly accepted by patients; provide an accurate dose vs. liquid form; can be designed to adjust solution pH.
2. Dispensing Tablets: Used by pharmacists to create drug solutions at a specific concentration; contain a higher amount of active ingredient than standard tablets.
3. Hypodermic Tablets: Contain water-soluble drugs specifically designed for injection into sterile water, to prepare a solution.
4. Tablet Triturates: Prepared by pharmacists using a potent drug; rarely used today.

Ideal Tablet

Elegance, Durability, and Stability: Free from defects; withstands mechanical stress during production, packaging, and dispensing; maintains chemical physical stability during shelf life; release medicinal agent(s) into the body reliably. Chemical stability over time prevents altering the medicinal agent(s).

Tablet Ingredients

Nontoxic and Legally acceptable: Nontoxic and legal within the market location.
Commercially Available: Available in a commercially reasonable manner.
Cost: Reasonably priced.
No Contraindication: Should not be harmful in the body; should not contraindicate use with component in the segment of the population. Physiological inert compounds (e.g., excipients, fillers) are necessary.
Chemical and Physical Stability: Should maintain qualities in combination with drugs and other tablet components. Stable independently and when combined.
Free of Microbiological contaminants: Must be free from unacceptable microbiological contaminants.
Color Compatibility: No undesired coloring changes during manufacture or storage.
Bioavailability: Does not alter the drug's bioavailability.

Tablet Excipients

Antioxidant: Prevents oxidation, deterioration of the preparation. Examples include ascorbic acid, butylated hydroxyanisole, or butylated hydroxytoluene, propyl gallate, sodium ascorbate, sodium bisulfite.
Tablet Anti-adherent: Prevents sticking of ingredients to punches and dies during production. Examples include Magnesium stearate, talc.
Tablet Binder: Makes granules stick together, providing adhesion of powder particles. Examples include acacia, carboxymethylcellulose, cellulose gelatin, ethyl pregelatinized starch, and methylcellulose.
Tablet Diluent: Fillers for solid dosage forms; examples include dibasic calcium phosphate, lactose, mannitol, microcrystalline cellulose, powdered cellulose, precipitated calcium carbonate, and sorbitol.
Tablet Disintegrant: Promote disruption of solid mass into smaller particles for faster dissolution. Examples include alginic acid, carboxymethylcellulose calcium, microcrystalline cellulose, polacrilin potassium, sodium alginate, sodium starch glycollate, and starch.
Tablet Glidant: Improve flow properties of the powder mixture. Examples include colloidal silica, corn starch, and talc.
Tablet Lubricant: Reduce friction during compression. Examples include calcium stearate, magnesium stearate, mineral oil, stearic acid, zinc stearate.

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