[ANAL-LEC-SEMIS-01-PT1] COMPENDIAL REQUIREMENTS FOR GELATIN CAPSULES

THIS FLASHCARDS IS ABOUT [ANALYSIS] COMPENDIAL REQUIREMENTS FOR GELATIN CAPSULES.

Hard and Soft Gelatin Capsules

What are the (2) Composition and Basic Types of Gelatin Capsules?

Hard Gelatin Capsules

IDENTIFY THE TYPE OF GELATIN CAPSULES:

The industry standard for manufacturers and extemporaneous compounding.

Soft Gelatin Capsules

IDENTIFY THE TYPE OF GELATIN CAPSULES:

Shells are modified with plasticizers (Glycerin or Sorbitol) to remain elastic.

• Glycerin

• Sorbitol

What are the (2) Examples of Plasticizers?

Elastic

In soft gelatin capsules, shells are modified with plasticizers like glycerin or sorbitol to remain?

• Myra E

• Fish oils

What are some examples of soft gelatin capsules available in the market?

1. Dry

2. Moist

3. Aqueous solutions

MICROBIAL STABILITY:

Gelatin is stable when (1)___ but highly susceptible to microbial decomposition when (2)___ or in (3)________.

Microbial Decomposition

What process occurs when gelatin becomes moist or placed in aqueous solutions, making it susceptible to breakdown by microorganisms?

Proper packaging

ENCAPSULATION GOAL:

This is mandatory to prevent degradation of the dosage form.

Degradation

What must be prevented in a dosage form through proper packaging?

13-16% Equilibrium

What is the standard moisture content of hard gelatin capsules at equilibrium?

• Shells soften

• Stick together

• Lose shape

What are the (3) High Humidity Risks of Shells?

Mnemonics: SSL

Do not dispense

What is the patient counseling for capsules that are dent or lost their rigidity?

1. Hygroscopic

2. Deliquescent

High Humidity Risks of Shells:

Failure to protect (1)___ or (2)___ materials.

Hygroscopic

What term describes materials that absorb moisture from the air without dissolving?

Deliquescent

What term describes materials that absorb so much moisture from the air that they dissolve in it?

• Brittle

• Harden

• Crack

Extreme Dryness Risks of Shells:

Under slight pressure, shells become?

Mnemonics: BHC

Desiccant Packets

Protective Measures:

Inclusion of ________ in containers is a standard precautionary measure to regulate the micro-environment.

The Pellicle Effect

What is the phenomenon called when gelatin undergoes cross-linking due to an irreversible chemical reaction after exposure to excessive heat and moisture or to aldehydes and peroxides?

Cross-linking

What is the irreversible chemical reaction in the pellicle effect?

• Excessive heat and moisture

• Aldehydes and Peroxides

The Pellicle Effect:

Cross-linking occurs when gelatin is exposed to?

Pellicle Formation

A thin, water-insoluble membrane that inhibits drug release.

Drug release

Pellicle formation inhibits what?

USP <711> Remediation Standards

This is a two-tier dissolution testing.

1. Enzymes

2. Dissolution Medium

USP <711> Remediation Standards:

If failure is attributed to cross-linking, USP allows the addition of (1)___ to the (2)________.

• Dissolution

• Disintegration

• Hardness

• Friability

Dosage forms are always tested whether it be (4)?

• Pepsin

• Papain/Bromelain

• Pancreatin

What are the (3) enzymes added to the dissolution medium to facilitate breakdown when drugs failed to dissolve?

Mnemonics: PPBP

Stomach

When a person took a medicine orally, what is the medium?

pH < 4.0

What is the medium pH of Pepsin?

750,000 units

Activity Requirement (per 1,000 mL):

Pepsin is not to exceed how many units?

pH 4.0-6.8

What is the medium pH of Papain/Bromelain?

550,000 units

Activity Requirement (per 1,000 mL):

How many units for Papain?

30 GDU

Activity Requirement (per 1,000 mL):

What is the needed Growing Degree Units (or Days) for Bromelain?

pH greater or equal to 6.8

What is the medium pH of Pancreatin (≥)?

2,000 units

Activity Requirement (per 1,000 mL):

Pancreatin’s protease activity must be not more than how many units?

USP <905> Uniformity of Dosage Units

Which USP general chapter sets the standards for evaluating the uniformity of dosage units in pharmaceutical preparations?

Hard Capsules

USP <905> Uniformity of Dosage Units:

Weight Variation Protocol:

Weigh 10 capsules; calculate net weight by subtracting the weight of the emptied shell.

1. 10 capsules

2. Subtracting

3. Emptied shell

Hard Capsules:

Weigh (1)___; calculate net weight by (2)___ the weight of the (3)___.

Soft Capsules

USP <905> Uniformity of Dosage Units:

Weight Variation Protocol:

Weigh 10 capsules; cut open and wash with a solvent (water); allow shells to dry for 30 minutes before final weighing.

1. 10 capsules

2. Solvent (water)

3. 30 minutes

4. Final weighing

Soft Capsules:

Weigh (1)___; cut open and wash with a (2)_______; allow shells to dry for (3)___ before (4)________.

85%-115% range

Acceptance Value:

Ensures the active ingredients stay within the standard range of?