1.1 - Introduction to Solid Dosage forms - Part 2

Proverbs 16:3

b. Capsule

[CAPSULES]

Solid dosage forms in which the drug is enclosed in either a hard or soft, soluble shell, usually made of gelatin
a. Tablet
b. Capsule
c. Suppository
d. Lozenge

a. Gelatin

[CAPSULES]

The product of partial hydrolysis of collagen.

a. Gelatin
b. Albumin
c. Casein
d. Keratin

• Type A Gelatin

• Type B Gelatin

[CAPSULES]

Types of Gelatin [2]

Type A Gelatin

[Types of Gelatin]

Mainly from pork skin

a. Type A

b. Type B

a. Acid processing

Type A gelatin is processed using:

a. Acid processing

b. Alkaline processing

Type B Gelatin

[Types of Gelatin]

From bones and animal skins

a. Type A

b. Type B

b. Alkaline processing

[CAPSULES]

Type B gelatin is processed using:

a. Acid processing

b. Alkaline processing

b. Bloom Strength

[CAPSULES]

Measure of gelatin rigidity

a. Viscosity index

b. Bloom Strength

c. Gel point

d. Tensile strength

b. 150 – 200g

[CAPSULES]

Bloom strength range for hard gelatin capsules (HGC).

a. 100 – 150g
b. 150 – 200g
c. 200 – 250g
d. 250 – 300g

b. 150g

[CAPSULES]

Bloom strength for soft gelatin capsules (SGC).

a. 100g

b. 150g

c. 200g

d. 250g

b. Collagen

[CAPSULES]

From the skin, white connective tissue, and bones of animals.

a. Gelatin
b. Collagen
c. Keratin
d. Elastin

Vegetable Capsules

[CAPSULES]

Alternative to gelatin

a. Starch capsules

b. Vegetable capsules

c. Cellulose capsules

d. Plastic capsules

• Hard Gelatin Capsules (HGC)

• Soft Gelatin Capsules (SGC)

Types of Capsules [2]

Hard Gelatin Capsules

[Types of Capsules]

Dry-filled or two-piece capsules

a. Hard Gelatin Capsules (HGC)

b. Soft Gelatin Capsules (SGC)

• Gelatin

• Sugar

• Water

[Types of Capsules]

Main Components of Hard Gelatin Capsules (HGC)

a. Gelatin, sugar, and alcohol
b. Gelatin, sugar, and water
c. Gelatin, glycerin, and water
d. Gelatin, starch, and water

• Colorant

• Opacifying agent

• 0.15% sulfur dioxide

[Types of Capsules]

Additives in Hard Gelatin Capsules include:

a. Colorant, opacifying agent, and 0.15% sodium benzoate

b. Colorant, opacifying agent, and 0.15% sulfur dioxide
c. Colorant, opacifying agent, and 0.10% methylparaben
d. Colorant, opacifying agent, and 0.10% propylparaben

a. Sulfur dioxide

[Types of Capsules]

Added to capsules to prevent decomposition of gelatin.

a. Sulfur dioxide
b. Sodium benzoate
c. Methylparaben
d. Propylparaben

c. 12% to 16%

[Types of Capsules]

Moisture content range for Hard Gelatin Capsules.

a. 8% to 12%
b. 10% to 14%
c. 12% to 16%
d. 14% to 18%

a. Brittle

[Types of Capsules]

Moisture content: <12

a. Brittle

b. Too soft

b. Too soft

[Types of Capsules]

Moisture content: >16

a. Brittle

b. Too soft

• Pulvule

• Spansule

Types of Hard Gelatin Capsule [2]

a. Pulvule

[Types of Hard Gelatin Capsule]

Tapered at one end

a. Pulvule

b. Spansule

Spansule HGC

[Types of Hard Gelatin Capsule]

Tapered at both ends

a. Pulvule

b. Spansule

a. Capsule # 000

[Types of Capsules]

Capsule size with a capacity of 15 grains (975 mg)

a. Capsule # 000

b. Capsule # 00

c. Capsule # 0

d. Capsule # 1

e. Capsule # 2

f. Capsule # 3

g. Capsule # 4

h. Capsule # 5

b. Capsule # 00

[Types of Capsules]

Capsule size with a capacity of 10 grains (650 mg)

a. Capsule # 000

b. Capsule # 00

c. Capsule # 0

d. Capsule # 1

e. Capsule # 2

f. Capsule # 3

g. Capsule # 4

h. Capsule # 5

c. Capsule # 0

[Types of Capsules]

Capsule size with a capacity of 7.5 grains (487.5 mg)

a. Capsule # 000

b. Capsule # 00

c. Capsule # 0

d. Capsule # 1

e. Capsule # 2

f. Capsule # 3

g. Capsule # 4

h. Capsule # 5

d. Capsule # 1

[Types of Capsules]

Capsule size with a capacity of 5 grains (325 mg)

a. Capsule # 000

b. Capsule # 00

c. Capsule # 0

d. Capsule # 1

e. Capsule # 2

f. Capsule # 3

g. Capsule # 4

h. Capsule # 5

e. Capsule # 2

[Types of Capsules]

Capsule size with a capacity of 4 grains (260 mg)

a. Capsule # 000

b. Capsule # 00

c. Capsule # 0

d. Capsule # 1

e. Capsule # 2

f. Capsule # 3

g. Capsule # 4

h. Capsule # 5

f. Capsule # 3

[Types of Capsules]

Capsule size with a capacity of 3 grains (195 mg)

a. Capsule # 000

b. Capsule # 00

c. Capsule # 0

d. Capsule # 1

e. Capsule # 2

f. Capsule # 3

g. Capsule # 4

h. Capsule # 5

g. Capsule # 4

[Types of Capsules]

Capsule size with a capacity of 2 grains (130 mg).

a. Capsule # 000

b. Capsule # 00

c. Capsule # 0

d. Capsule # 1

e. Capsule # 2

f. Capsule # 3

g. Capsule # 4

h. Capsule # 5

h. Capsule # 5

[Types of Capsules]

Capsule size with a capacity of 1 grain (65 mg)

a. Capsule # 000

b. Capsule # 00

c. Capsule # 0

d. Capsule # 1

e. Capsule # 2

f. Capsule # 3

g. Capsule # 4

h. Capsule # 5

a. Capsule # 000

[Types of Capsules]

The largest capsule size is:

a. Capsule # 000

b. Capsule # 00

c. Capsule # 0

d. Capsule # 1

e. Capsule # 2

f. Capsule # 3

g. Capsule # 4

h. Capsule # 5

h. Capsule # 5

[Types of Capsules]

The smallest capsule size is:

a. Capsule # 000

b. Capsule # 00

c. Capsule # 0

d. Capsule # 1

e. Capsule # 2

f. Capsule # 3

g. Capsule # 4

h. Capsule # 5

b. Soft Gelatin Capsules (SGC)

[Types of Capsules]

One-piece capsules

a. Hard Gelatin Capsules (HGC)

b. Soft Gelatin Capsules (SGC)

b. Soft Gelatin Capsules (SGC)

[Types of Capsules]

Used to contain non-aqueous liquids (e.g. Vit A, Vit D, Vit E, cod liver oil), suspensions, pastes, and dry materials

a. Hard Gelatin Capsules (HGC)

b. Soft Gelatin Capsules (SGC)

• Gelatin

• Glycerin / sorbitol

• Preservative

[Types of Capsules]

Main Components of Soft Gelatin Capsules (SGC) [3]

c. 6% to 10%

[Types of Capsules]

Moisture content range for Soft Gelatin Capsules.

a. 12% to 16%

b. 10% to 14%

c. 6% to 10%

d. 8% to 12%

Spansule

[NOTES]

A capsule composed of hard gelatin shell containing hundreds of tiny, coated beads / pellets of drugs for sustained release

a. Spansule

b. Cachet

c. Parvules

d. Pulvules

e. Troche

f. Pellets / Implants

g. Snapfit / Coni-Snap / Coni-Snap Supro

Cachet

[NOTES]

• A flat containing drug that has an unpleasant taste

• Swallowed intact by the patient

• Drug is enclosed in a solid sheet made from rice flour and water (wafer)

a. Spansule

b. Cachet

c. Parvules

d. Pulvules

e. Troche

f. Pellets / Implants

g. Snapfit / Coni-Snap / Coni-Snap Supro

Parvules

[NOTES]

Very small pills

a. Spansule

b. Cachet

c. Parvules

d. Pulvules

e. Troche

f. Pellets / Implants

g. Snapfit / Coni-Snap / Coni-Snap Supro

Pulvules

[NOTES]

Bullet-shaped

a. Spansule

b. Cachet

c. Parvules

d. Pulvules

e. Troche

f. Pellets / Implants

g. Snapfit / Coni-Snap / Coni-Snap Supro

Troche

[NOTES]

A medicinal lozenge, taken by mouth, used to treat conditions of the mouth or throat and also of the alimentary canal

a. Spansule

b. Cachet

c. Parvules

d. Pulvules

e. Troche

f. Pellets / Implants

g. Snapfit / Coni-Snap / Coni-Snap Supro

Pellets/Implants

[NOTES]

Are sterile, small, usually cylindrical solid object intended to be implanted subcutaneously to provide continuous release of medication over time

a. Spansule

b. Cachet

c. Parvules

d. Pulvules

e. Troche

f. Pellets / Implants

g. Snapfit / Coni-Snap / Coni-Snap Supro

c. Implants

[NOTES]

Pellets is also known as:

a. Beads
b. Spheroids
c. Implants
d. Microparticles

Snapfit/Coni-Snap/Coni-Snap Supro

[NOTES]

Two halves of the capsule shell be positively joined through locking grooves

a. Spansule

b. Cachet

c. Parvules

d. Pulvules

e. Troche

f. Pellets / Implants

g. Snapfit / Coni-Snap / Coni-Snap Supro

c. Both a and b

• Coni-Snap

• Coni-Snap Supro

[NOTES]

Snapfit is also known as:

a. Coni-Snap
b. Coni-Snap Supro
c. Both a and b
d. Neither a nor b

b. Solid Oral Modified Release

Solid dosage forms in which the drug release features are based on time, course, and location.

a. Immediate release tablets
b. Solid Oral Modified Release
c. Effervescent tablets
d. Chewable tablets

• Economic savings

• Avoid patient compliance problems

• Reduce fluctuation in drug level

• Minimize or eliminate side effects

Advantages of Solid Oral Modified Release [4]

…

[Mechanism of Immediate Release Formulation]

• Extended Release

• Delayed-Release

• Repeat-Action

• Target-Release

Types of Modified Release Dosage Forms [4]

a. Extended-Release

[Types of Modified Release Dosage Forms]

Provides a prompt desired effect followed by gradual release of the remaining drug

a. Extended-Release

b. Delayed-Release

c. Repeat-Action

d. Targeted-Release

• Controlled release

• Sustained release

[Types of Modified Release Dosage Forms]

Types of Extended-Release [2]

b. Delayed-Release

[Types of Modified Release Dosage Forms]

Drug release is other than the time of prompt administration

a. Extended-Release

b. Delayed-Release

c. Repeat-Action

d. Targeted-Release

c. Repeat-Action

[Types of Modified Release Dosage Forms]

• Contains 2 single doses of a medication

• One for immediate-release and another for delayed-release

a. Extended-Release

b. Delayed-Release

c. Repeat-Action

d. Targeted-Release

Targeted Release

[Types of Modified Release Dosage Forms]

Drug release is isolated in a specific body region or tissue

a. Extended-Release

b. Delayed-Release

c. Repeat-Action

d. Targeted-Release

c. Both a and b

• Colonic Tablets

• Gastro Retentive Tablets

[Types of Modified Release Dosage Forms]

Examples of drugs that have targeted release.

a. Colonic Tablets
b. Gastro Retentive Tablets
c. Both a and b
d. Neither a nor b

a. Colonic Tablets

[Types of Modified Release Dosage Forms - Targeted Release]

Deliver the drug into the colon without dilution in other regions of GIT

a. Colonic Tablets

b. Gastro Retentive Tablets

b. Gastro Retentive Tablets

[Types of Modified Release Dosage Forms - Targeted Release]

Remain in the stomach for long periods

a. Colonic Tablets

b. Gastro Retentive Tablets

• Coated Bead, Granules & Microsphere

• Multi-tablet System

• Microencapsulation

• Embedding Drug in Slowly Eroding or Hydrophilic Matrix System

• Embedding Drug in Inert Plastic Matrix

• Complex Formation

• Ion Exchange Resins

• Osmotic Pump

Extended Release Technology of Oral Dosage Forms [8]

a. Coated Bead, Granules & Microsphere

[Extended Release Technology of Oral Dosage Forms]

The drug is distributed onto beads, pellets, granules, or other particulate systems

a. Coated Bead, Granules & Microsphere

b. Multi-tablet System

c. Microencapsulation

d. Embedding Drug in Slowly Eroding or Hydrophilic Matrix System

e. Embedding Drug in Inert Plastic Matrix

f. Complex Formation

g. Ion Exchange Resins

h. Osmotic Pump

a. Coated Bead, Granules & Microsphere

[Extended Release Technology of Oral Dosage Forms]

Spansule (SmithKline Beecham) is an example of:

a. Coated Bead, Granules & Microsphere

b. Multi-tablet System

c. Microencapsulation

d. Embedding Drug in Slowly Eroding or Hydrophilic Matrix System

e. Embedding Drug in Inert Plastic Matrix

f. Complex Formation

g. Ion Exchange Resins

h. Osmotic Pump

b. Multi-tablet System

[Extended Release Technology of Oral Dosage Forms]

• Small spheroids compressed tablets

• 3 to 4 mm in diameter

• May be placed in gelatin capsule shells to provide the desired pattern of drug release

a. Coated Bead, Granules & Microsphere

b. Multi-tablet System

c. Microencapsulation

d. Embedding Drug in Slowly Eroding or Hydrophilic Matrix System

e. Embedding Drug in Inert Plastic Matrix

f. Complex Formation

g. Ion Exchange Resins

h. Osmotic Pump

d. 8-10 minitablets

[Extended Release Technology of Oral Dosage Forms]

In the Multi-tablet System, each capsule may contain _____ minitablets

a. 2-4 minitablets

b. 4-6 minitablets

c. 6-8 minitablets

d. 8-10 minitablets

1. Uncoated

2. Coated

[Extended Release Technology of Oral Dosage Forms]

In the Multi-tablet System:

1. ________ - for immediate release

2. ________ - for extended release

a. Uncoated

b. Coated

Microencapsulation

[Extended Release Technology of Oral Dosage Forms]

Process by which solid, liquid, or even gasses may be enclosed in microscopic particles by formation of thin coatings of wall material around the substances

a. Coated Bead, Granules & Microsphere

b. Multi-tablet System

c. Microencapsulation

d. Embedding Drug in Slowly Eroding or Hydrophilic Matrix System

e. Embedding Drug in Inert Plastic Matrix

f. Complex Formation

g. Ion Exchange Resins

h. Osmotic Pump

b. Gelatin

[Materials in Microencapsulation]

Common wall-forming material used in microencapsulation.

a. Starch

b. Gelatin

c. Lactose

d. Sucrose

• Polyvinyl alcohol

• Ethylcellulose

• Polyvinyl chloride

[Materials in Microencapsulation]

Synthetic polymers used in microencapsulation include [3]

a. Enhanced absorption by diminished local drug concentration due to small units of the drug spread over a large area of the GIT

[Materials in Microencapsulation]

Advantage of microencapsulation:

a. Enhanced absorption by diminished local drug concentration due to small units of the drug spread over a large area of the GIT
b. Decreased absorption due to large drug particles
c. Increased local irritation
d. Delayed onset of action

d. Embedding Drug in Slowly Eroding or Hydrophilic Matrix System

[Extended Release Technology of Oral Dosage Forms]

Drug + excipient that slowly erodes in body fluids

a. Coated Bead, Granules & Microsphere

b. Multi-tablet System

c. Microencapsulation

d. Embedding Drug in Slowly Eroding or Hydrophilic Matrix System

e. Embedding Drug in Inert Plastic Matrix

f. Complex Formation

g. Ion Exchange Resins

h. Osmotic Pump

a. Hydrophilic Cellulose Polymers

[Extended Release Technology of Oral Dosage Forms]

Commonly used excipient base in tablet matrix systems

a. Hydrophilic Cellulose Polymers

b. Hydroxypropyl methylcellulose (HPMC)

b. Hydroxypropyl methylcellulose (HPMC)

[Extended Release Technology of Oral Dosage Forms]

Commonly used to provide the hydrophilic matrix
a. Hydrophilic Cellulose Polymers

b. Hydroxypropyl methylcellulose (HPMC)

a. Oramorph SR Tablets (Morphine SO₄) – by AllPharma

[Extended Release Technology of Oral Dosage Forms]

Example of a drug product using hydrophilic matrix system.

a. Oramorph SR Tablets (Morphine SO₄) – by AllPharma

b. Micro-K Extencaps

c. Spansule

d. Oros

Embedding Drug in Inert Plastic Matrix

[Extended Release Technology of Oral Dosage Forms]

Drug is granulated with an inert plastic material (e.g. polyethylene, polyvinyl acetate, polymethacrylate)

a. Coated Bead, Granules & Microsphere

b. Multi-tablet System

c. Microencapsulation

d. Embedding Drug in Slowly Eroding or Hydrophilic Matrix System

e. Embedding Drug in Inert Plastic Matrix

f. Complex Formation

g. Ion Exchange Resins

h. Osmotic Pump

e. Embedding Drug in Inert Plastic Matrix

[Extended Release Technology of Oral Dosage Forms]

Slowly released from the inert plastic matrix by diffusion

a. Coated Bead, Granules & Microsphere

b. Multi-tablet System

c. Microencapsulation

d. Embedding Drug in Slowly Eroding or Hydrophilic Matrix System

e. Embedding Drug in Inert Plastic Matrix

f. Complex Formation

g. Ion Exchange Resins

h. Osmotic Pump

b. Inert matrix

[Extended Release Technology of Oral Dosage Forms]

In Embedding Drug in inert plastic matrix system:

• _______ is excreted with the feces.

a. Active drug

b. Inert matrix

c. Plasticizer

d. Coating material

b. Gradumet (Abbott)

[Extended Release Technology of Oral Dosage Forms]

Example of a drug product using Embedding Drug in Inert Plastic Matrix

a. Oramorph SR Tablets

b. Gradumet (Abbott)

c. Spansule

d. Oros

Complex Formation

[Extended Release Technology of Oral Dosage Forms]

Some drug substances, when chemically combined with certain other chemical agents, form complexes that may be only slowly soluble in body fluids = slow dissolution rate

a. Coated Bead, Granules & Microsphere

b. Multi-tablet System

c. Microencapsulation

d. Embedding Drug in Slowly Eroding or Hydrophilic Matrix System

e. Embedding Drug in Inert Plastic Matrix

f. Complex Formation

g. Ion Exchange Resins

h. Osmotic Pump

c. Tannates (Salt of Tannic acid)

[Extended Release Technology of Oral Dosage Forms]

Example of a drug product using complex formation.

a. Gradumet

b. Oramorph SR

c. Tannates

d. Spansule

b. Tannates

[Extended Release Technology of Oral Dosage Forms]

Salts of Tannic acid (Rynatan) is known as:

a. Citrates

b. Tannates

c. Acetates

d. Carbonates

a. Rynatan (Wallace)

[Extended Release Technology of Oral Dosage Forms]

Tannates are salts of tannic acid. Which brand product is an example of this?

a. Rynatan (Wallace)

b. Gradumet (Abbott)

c. Oramorph SR (AllPharma)

d. Spansule (SmithKline Beecham)

Ion Exchange Resins

[Extended Release Technology of Oral Dosage Forms]

A cationic drug is passed through a column of ion-exchange resin, forming a complex by the replacement of hydrogen atoms.

a. Coated Bead, Granules & Microsphere

b. Multi-tablet System

c. Microencapsulation

d. Embedding Drug in Slowly Eroding or Hydrophilic Matrix System

e. Embedding Drug in Inert Plastic Matrix

f. Complex Formation

g. Ion Exchange Resins

h. Osmotic Pump

d. Hydrogen atoms

[Extended Release Technology of Oral Dosage Forms]

In ion exchange resin systems, the drug-resin complex is formed by the replacement of:

a. Sodium atoms
b. Calcium atoms
c. Potassium atoms
d. Hydrogen atoms

a. Complex

[Extended Release Technology of Oral Dosage Forms]

In ion exchange resin systems, the _______ is washed and may be tableted, encapsulated, or suspended in an aqueous vehicle.

a. Complex
b. Free drug
c. Ion-exchange resin
d. Excipient

b. pH and electrolyte concentration of the GIT

[Extended Release Technology of Oral Dosage Forms]

In ion exchange resin systems, drug release depends on:

a. Temperature only

b. pH and electrolyte concentration of the GIT

c. Particle size only

d. Compression force only

c. Acidic pH

[Extended Release Technology of Oral Dosage Forms]

In ion exchange resin systems, _____ pH produces greater drug release?

a. Alkaline pH

b. Neutral pH

c. Acidic pH

d. pH independent

c. Both a and b

• Hydrocodone Polistirex

• Chlorpheniramine Polistirex Suspension

[Extended Release Technology of Oral Dosage Forms]

Examples of ion exchange resin products include:

a. Hydrocodone Polistirex
b. Chlorpheniramine Polistirex Suspension
c. Both a and b
d. Neither a nor b

a. Hydrocodone Polistirex and Chlorpheniramine Polistirex

[Extended Release Technology of Oral Dosage Forms]

Tussionex Pennkinetic Extended Release Suspension contains which active ingredients?

a. Hydrocodone Polistirex and Chlorpheniramine Polistirex

b. Morphine sulfate

c. Phentermine resin

d. Tannic acid salts

Osmotic Pump

[Extended Release Technology of Oral Dosage Forms]

Composed of a core tablet surrounded by a semipermeable membrane coating having a 0.4 diameter hole produced by laser beam

a. Coated Bead, Granules & Microsphere

b. Multi-tablet System

c. Microencapsulation

d. Embedding Drug in Slowly Eroding or Hydrophilic Matrix System

e. Embedding Drug in Inert Plastic Matrix

f. Complex Formation

g. Ion Exchange Resins

h. Osmotic Pump

b. Oros System (by Alza)

Pioneer oral osmotic pump drug delivery system.

a. Gradumet
b. Oros System (by Alza)
c. Spansule
d. Oramorph SR

d. All of the above

• Glucotrol XL

• Procardia XL

• Covera HS

Examples of Osmotic Pump Systems include:

a. Glucotrol XL
b. Procardia XL
c. Covera HS
d. All of the above

c. Suppositories

Solid or semisolid masses intended to be inserted into a body orifice for local or systemic effect
a. Tablets
b. Capsules
c. Suppositories
d. Powders

c. Suppositories

Used when oral route is inadvisable

a. Tablets
b. Capsules
c. Suppositories
d. Powders

• Inconvenient

• Erratic absorption

[Type of Suppositories]

Disadvantages of Suppositories [2]

• Rectal

• Vaginal (Pessaries)

• Urethral (Buogies)

Types of Suppositories [3]

b. Vaginal Suppositories

[Type of Suppositories]

Pessaries

a. Rectal Suppositories

b. Vaginal Suppositories

c. Urethral Suppositories

c. Urethral Suppositories

[Type of Suppositories]

Bougies

a. Rectal Suppositories

b. Vaginal Suppositories

c. Urethral Suppositories

Rectal suppositories

[Type of Suppositories]

• Bullet shape

• Torpedo shape

• Little finger shape

a. Rectal Suppositories

b. Vaginal Suppositories

c. Urethral Suppositories

b. Vaginal Suppositories

[Type of Suppositories]

• Globular shape

• Ovoid shape

• Cone shape

a. Rectal Suppositories

b. Vaginal Suppositories

c. Urethral Suppositories

c. Urethral Suppositories

[Type of Suppositories]

Pencil-like shape

a. Rectal Suppositories

b. Vaginal Suppositories

c. Urethral Suppositories

a. Rectal Suppositories

[Type of Suppositories]

Suppository weight:

• 2g for adults

• 1g for children

a. Rectal Suppositories

b. Vaginal Suppositories

c. Urethral Suppositories