[DOSAGE FORMS] Introduction to Solid Dosage forms - Part 1

Proverbs 16:3

b. Dosage Forms

[DEFINITION OF TERMS]

Drug products or preparations containing the API and excipients.

a. Drug Delivery Systems
b. Dosage Forms
c. Excipients
d. Drugs

c. Drug Delivery Systems

[DEFINITION OF TERMS]

Drug products that allow the uniform release and targeting of drugs into the body.

a. Dosage Forms
b. Excipients
c. Drug Delivery Systems
d. Additives

d. Drug

[DEFINITION OF TERMS]

An agent intended for use in the diagnosis, mitigation, cure, treatment, and/or prevention of disease in man and other animals.

a. Excipient
b. Dosage Form
c. Drug Delivery System
d. Drug

c. Excipients / Adjuncts / Additives

[DEFINITION OF TERMS]

Non-therapeutic ingredients which improve the physical characteristics and efficacy of a drug in a dosage form.

a. Drugs
b. Active ingredients
c. Excipients / Adjuncts / Additives
d. Drug Delivery Systems

• Adjuncts

• Additives

[DEFINITION OF TERMS]

Excipient is also known as _____ [2]

a. Drug and API
b. Adjuncts and Additives
c. Dosage forms and Delivery systems
d. Therapeutics and Pharmaceuticals

a. Cosmetics

[DEFINITION OF TERMS]

Any substance or preparation intended to be placed in contact with the external parts of the human body, or with the teeth, or mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, correcting body odors, changing their appearance, protecting them, or keeping them in good condition.

a. Cosmetics
b. Drugs
c. Medical devices
d. Dietary supplements

c. Food Supplements

[DEFINITION OF TERMS]

Processed food products that help supplement the diet.

a. Drugs
b. Cosmetics
c. Food Supplements
d. Medical devices

c. Food Supplements

[DEFINITION OF TERMS]

Processed food products that may contain dietary ingredients such as vitamins, minerals, herbs, amino acids, and other dietary substances

a. Drugs
b. Cosmetics
c. Food Supplements
d. Medical devices

c. Food Supplements

[DEFINITION OF TERMS]

Processed food products that may take various forms, including those of liquids, capsules, powders, etc., except parenterals

a. Drugs
b. Cosmetics
c. Food Supplements
d. Medical devices

b. Compounding

[DEFINITION OF TERMS]

Process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.

a. Manufacturing
b. Compounding
c. Dispensing
d. Packaging

a. Local effect

[LOCAL AND SYSTEMIC EFFECTS]

Felt in the general area of administration

a. Local effect

b. Systemic effect

a. Local effect

[LOCAL AND SYSTEMIC EFFECTS]

Common route Local effect

a. Topical

b. Oral and parenteral

b. Local effects

[LOCAL AND SYSTEMIC EFFECTS]

• Betadine

• Vaseline petroleum jelly

• Spray solutions

Are examples of drugs that produce:

a. Systemic effects

b. Local effects

b. Systemic effect

[LOCAL AND SYSTEMIC EFFECTS]

Occur in tissues distant from the site of contact between the body and the drug

a. Local effect

b. Systemic effect

b. Systemic effect

[LOCAL AND SYSTEMIC EFFECTS]

Drug must enter the bloodstream

a. Local effect

b. Systemic effect

b. Oral and parenteral

[LOCAL AND SYSTEMIC EFFECTS]

Common route for Systemic effect

a. Topical

b. Oral and parenteral

a. Systemic effects

• Lanoxin elixir

• Oral solid dosage forms

• Parenterals

Are examples of drugs that produce:

a. Systemic effects

b. Local effects

a. Solid dosage forms

Forms of medication that are solid in nature.

a. Solid dosage forms

b. Liquid dosage forms

Particle Size Analysis

[SOLID DOSAGE FORMS]

Used to obtain quantitative data on the size, distribution, and shapes of the drug and other components to be used in pharmaceutical formulations.

a. Sieving

[Methods of Determining Particle Size]

Passed by mechanical shaking

a. Sieving

b. Microscopy

c. Sedimentation Rate

d. Light Energy Diffraction / Light Scattering

e. Laser Holography

f. Cascade Impaction

b. Microscopy

[Methods of Determining Particle Size]

Through the use of a calibrated grid

a. Sieving

b. Microscopy

c. Sedimentation Rate

d. Light Energy Diffraction / Light Scattering

e. Laser Holography

f. Cascade Impaction

c. Sedimentation Rate

[Methods of Determining Particle Size]

By measuring the terminal settling velocity of particles through a liquid medium

a. Sieving

b. Microscopy

c. Sedimentation Rate

d. Light Energy Diffraction / Light Scattering

e. Laser Holography

f. Cascade Impaction

d. Light Energy Diffraction / Light Scattering

[Methods of Determining Particle Size]

By the reduction in light reaching the sensor as the particle

a. Sieving

b. Microscopy

c. Sedimentation Rate

d. Light Energy Diffraction / Light Scattering

e. Laser Holography

f. Cascade Impaction

e. Laser Holography

[Methods of Determining Particle Size]

A pulsed laser is fired through an aerosol particle spray

a. Sieving

b. Microscopy

c. Sedimentation Rate

d. Light Energy Diffraction / Light Scattering

e. Laser Holography

f. Cascade Impaction

f. Cascade Impaction

[Methods of Determining Particle Size]

By an airstream

a. Sieving

b. Microscopy

c. Sedimentation Rate

d. Light Energy Diffraction / Light Scattering

e. Laser Holography

f. Cascade Impaction

a. Potency

[NOTES]

Use geometric dilution.

a. Potency

b. Eutexia

b. Eutexia

[NOTES]

Reduction of melting point when combined with other eutectic substances causing liquefaction and wet powder

a. Potency

b. Eutexia

• Camphor

• Menthol

• Thymol

• Aspirin

• Phenyl salicylate

Examples of substances causing eutectic mixtures [5]

• Light MgO

• Mg carbonate

Inert diluents to avoid eutexia [2]

Powders

Mixtures of finely divided drugs and/or chemicals in a dry form that may be intended for internal or external use

• Rapid dispersion of ingredients

• Flexibility in compounding

• Good chemical stability

[POWDERS]

Advantages of Powders [3]

• Inaccuracy of dose

• Not suitable for unpleasant tasting, deliquescent, and hygroscopic drugs

[POWDERS]

Disadvantages of Powders [2]

b. Sieve number

[USP CLASSIFICATION OF POWDERS]

Number of square openings per linear inch.

a. Mesh size
b. Sieve number
c. Particle size
d. Screen factor

a. Very coarse

[USP CLASSIFICATION OF POWDERS]

Sieve No. 8

a. Very coarse

b. Coarse

c. Moderately coarse

d. Fine

e. Very fine

b. Coarse

[USP CLASSIFICATION OF POWDERS]

Sieve No. 20

a. Very coarse

b. Coarse

c. Moderately coarse

d. Fine

e. Very fine

c. Moderately coarse

[USP CLASSIFICATION OF POWDERS]

Sieve No. 30

a. Very coarse

b. Coarse

c. Moderately coarse

d. Fine

e. Very fine

d. Fine

[USP CLASSIFICATION OF POWDERS]

Sieve No. 60

a. Very coarse

b. Coarse

c. Moderately coarse

d. Fine

e. Very fine

Very Fine

[USP CLASSIFICATION OF POWDERS]

Sieve No. 80

a. Very coarse

b. Coarse

c. Moderately coarse

d. Fine

e. Very fine

• Comminution

  • Trituration

  • Levigation

  • Pulverization by intervention

• Mixing

  • Trituration

  • Spatulation

  • Sifting

  • Geometric Dilution

  • Tumbling

Methods in Compounding of Powders [2]

• Trituration

• Levigation

• Pulverization by intervention

Comminution Methods in Compounding of Powders [3]

• Trituration

• Spatulation

• Sifting

• Geometric Dilution

Mixing Methods in Compounding of Powders [4]

a. Trituration

[Compounding of Powders - Comminution]

Uses a mortar and pestle

a. Trituration

b. Levigation

c. Pulverization by intervention

Trituration

[Compounding of Powders - Comminution]

This method can be used for both MIXING AND COMMINUTION method for compounding powders MORTAT and PESTLE.

a. Trituration

b. Levigation

c. Pulverization by intervention

b. Levigation

[Compounding of Powders - Comminution]

Forming a paste by the addition of a non-solvent liquid

a. Trituration

b. Levigation

c. Pulverization by intervention

c. Pulverization by intervention

[Compounding of Powders - Comminution]

Addition of volatile substance to a gummy material

a. Trituration

b. Levigation

c. Pulverization by intervention

a. Glass

[Types of Mortar and Pestle for Mixing]

Smooth, non-porous surface

a. Glass

b. Porcelain

c. Wedgewood

b. Porcelain

[Types of Mortar and Pestle for Mixing]

Rough inner surface

a. Glass

b. Porcelain

c. Wedgewood

c. Wedgewood

[Types of Mortar and Pestle for Mixing]

Rougher inner surface

a. Glass

b. Porcelain

c. Wedgewood

Spatulation

[Compounding of Powders - Mixing]

Blending of powders with a spatula on a tile or paper

a. Trituration

b. Spatulation

c. Sifting

d. Geometric dilution

e. Tumbling

Spatulation

[Compounding of Powders - Mixing]

Use for:

• Small quantities

• Non-potent drugs

• Eutectic mixtures

a. Trituration

b. Spatulation

c. Sifting

d. Geometric dilution

e. Tumbling

c. Sifting

[Compounding of Powders - Mixing]

Powders are passed through sifters

a. Trituration

b. Spatulation

c. Sifting

d. Geometric dilution

e. Tumbling

Geometric Dilution

[Compounding of Powders - Mixing]

Addition of equal volume of a diluent to a potent substance in a mortar

a. Trituration

b. Spatulation

c. Sifting

d. Geometric dilution

e. Tumbling

Tumbling

[Compounding of Powders - Mixing]

Large containers rotated by a motorized process

a. Trituration

b. Spatulation

c. Sifting

d. Geometric dilution

e. Tumbling

• Bulk Powders

• Divided Powders (Chartulae)

Types of Powders [2]

a. Chartulae

Divided powder is also known as:

a. Chartulae
b. Insufflations
c. Dusting powders
d. Bulk powders

a. Oral Powders

[Types of Powders - Bulk Powders]

Dissolved in water prior to use

a. Oral Powders

b. Dentrifices

c. Dusting Powders

d. Douche Powders

e. Insufflations

b. Dentrifices

[Types of Powders - Bulk Powders]

Used to clean and polish teeth

a. Oral Powders

b. Dentrifices

c. Dusting Powders

d. Douche Powders

e. Insufflations

c. Dusting Powders

[Types of Powders - Bulk Powders]

Locally applied, non-toxic powders that have no systemic action

a. Oral Powders

b. Dentrifices

c. Dusting Powders

d. Douche Powders

e. Insufflations

d. Douche Powders

[Types of Powders - Bulk Powders]

Dissolved in warm water prior to introduction into a body cavity

a. Oral Powders

b. Dentrifices

c. Dusting Powders

d. Douche Powders

e. Insufflations

e. Insufflations

[Types of Powders - Bulk Powders]

Blown into a body cavity

a. Oral Powders

b. Dentrifices

c. Dusting Powders

d. Douche Powders

e. Insufflations

a. Divided powders (Chartulae)

[Type of Powders]

Dispensed in individual doses usually in folded papers.

a. Divided powders (Chartulae)
b. Bulk powders
c. Insufflations
d. Dusting powders

a. Block and divide method

[Type of Powders]

Method used for divided powders (Chartulae).

a. Block and divide method
b. Trituration method
c. Levigation method
d. Pulverization method

a. Divided powders (Chartulae)

[Type of Powders]

Each dose is separately wrapped in paper or sealed in a sachet (for potent drugs)

a. Divided powders (Chartulae)
b. Bulk powders
c. Insufflations
d. Dusting powders

a. Bond Paper

[Types of Powder Paper]

Opaque paper with no moisture resistance

a. Bond Paper

b. Vegetable Parchment

c. Glassine

d. Waxed Paper

b. Vegetable Parchment

[Types of Powder Paper]

Thin, semi-opaque paper with limited moisture resistance

a. Bond Paper

b. Vegetable Parchment

c. Glassine

d. Waxed Paper

c. Glassine

[Types of Powder Paper]

Glazed, transparent paper with limited moisture resistance

a. Bond Paper

b. Vegetable Parchment

c. Glassine

d. Waxed Paper

d. Waxed Paper

[Types of Powder Paper]

Transparent waterproof paper

a. Bond Paper

b. Vegetable Parchment

c. Glassine

d. Waxed Paper

a. Vegetable Parchment

[NOTES]

Used only if limited barrier againts moisture is necessary

a. Vegetable Parchment

b. Waxed Paper , Glassine

• Waxed Paper

• Glassine

[NOTES]

Used for volatile components

a. Vegetable Parchment

b. Waxed Paper , Glassine

a. Granules

Dry aggregates of powder particles

a. Granules

b. Powders

c. Pastes

d. Gel

b. Sieve No. 4 – 12

Sieve number range for normal granules.

a. Sieve No. 2 – 4
b. Sieve No. 4 – 12
c. Sieve No. 12 – 20
d. Sieve No. 20 – 40

c. Sieve No. 12 – 20

Sieve number range for granules used in tablet formulation.

a. Sieve No. 2 – 4
b. Sieve No. 4 – 12
c. Sieve No. 12 – 20
d. Sieve No. 20 – 40

• Flow well compared to powders

• Less tendency to cake or harden

• More stable to humidity

• More easily wetted by liquids

Advantages of granules [4]

• Wet Granulation

• Dry Granulation

Methods for Compounding Granules [2]

a. Wet Granulation

[Methods for Compounding Granules]

Most common method of granulation

a. Wet Granulation

b. Dry Granulation

a. Wet Granulation

[Methods for Compounding Granules]

Addition of granulating fluid or liquid binder

a. Wet Granulation

b. Dry Granulation

b. Dry Granulation

[Methods for Compounding Granules]

For moisture-sensitive and heat-labile materials

a. Wet Granulation

b. Dry Granulation

b. Dry Granulation

[Methods for Compounding Granules]

Uses compaction or compression forces

a. Wet Granulation

b. Dry Granulation

Effervescent Granules

[Methods for Compounding Granules - Dry Granulation]

Dissolved in water before use where CO2 gas is released

a. Effervescent granules
b. Divided powders
c. Bulk powders
d. Dusting powders

• 1 part citric acid

• 2 parts tartaric acid

• 3.4 parts sodium bicarbonate

Ratio: 1 : 2 : 3.4

Components of Effervescent Granules [2]

b. Stickiness

[Components of Effervescent Granules]

In effervescent granules, too much citric acid results in:

a. Crumbling
b. Stickiness
c. Delayed release
d. No reaction

c. Crumbling

[Components of Effervescent Granules]

In effervescent granules, too much tartaric acid results in:

a. Stickiness
b. Delayed dissolution
c. Crumbling
d. Increased potency

c. Sodium bicarbonate

[Components of Effervescent Granules]

The base component in effervescent granules is:

a. Citric acid
b. Tartaric acid
c. Sodium bicarbonate
d. Ascorbic acid

d. Both a and b

• Dry / Fusion Method

• Wet Method

Effervescent Granules can be prepared by:

a. Dry / Fusion Method

b. Wet Method

c. Nascent Soap Method

d. Both a and b

e. All of the above

Dry/Fusion Method

[Method of Preparing Effervescent Granules]

Releases water of crystallization of ingredients

a. Dry / Fusion Method

b. Wet Method

a. Dry / Fusion method

[Method of Preparing Effervescent Granules]

Binder is 1 molecule of H₂O in citric acid.

a. Dry / Fusion method
b. Wet method

Wet Method

[Method of Preparing Effervescent Granules]

Binder is OH + H₂O.

a. Dry / Fusion method
b. Wet method

• Good Granules

• Fine Granules

Types of Granules [2]

a. Good Granules

[Types of Granules]

Particles that passthrough sieve #20 but not through sieve #40

a. Good Granules

b. Fine Granules

• As spherical as possible

• Uniform in content

• Normal or bell-shaped distribution of particle size

Qualities of Good Granulation [3]

b. Fine Granules

[Types of Granules]

Particles that pass sieve #40

a. Good Granules

b. Fine Granules

b. Fine Granules

[Types of Granules]

Acts as bridges by filling inter-particulate spaces

a. Good Granules

b. Fine Granules

b. Excess fines

[Types of Granules - Fine Granules]

Inter-particulate friction is caused by:

a. Excess fines

b. Excess granules

b. Excess granules

[Types of Granules - Fine Granules]

Presence of void spaces is caused by:

a. Excess fines

b. Excess granules

b. Tablet

Solid dosage forms that are prepared by molding or compression

a. Capsule

b. Tablet

• Uniform content

• Less manufacturing cost

• Easy to package and ship

• Simple to identify

• Most stable among oral dosage forms

• Tamperproof

Advantages of Tablets [6]

• Some drugs resist compression

• Some drugs that require encapsulation prior to compression

Disadvatanges of Tablets [2]

• Tablets for Oral Ingestion

  • Compressed Tablets

  • Multiple Compressed Tablets

  • Coated Tablets

• Tablets used in the Oral Cavity

  • Chewable Tablets

  • Rapidly / Orally Disintegrating Tablets (RDT/ODT)

  • Buccal Tablets

  • Sublingual Tablets

  • Lozenges

• Tablets used to Prepare Solutions

  • Effervescent Tablets

  • Dispensing / Compounding Tablets

  • Hypodermic Tablets

  • Molded Tablets / Tablet Triturates

Types of Tablets [2]

• Compressed Tablets

• Multiple Compressed Tablets

• Coated Tablets

Type of Tablets for Oral Ingestion [3]

Compressed Tablets

[Tablets for Oral Ingestion]

• Formed by compression

• Some are scored