[ANAL-LAB-MID-02] COMPENDIAL REQUIREMENTS FOR SOLID AND SEMI-SOLID DOSAGE FORMS

THIS FLASH CARDS IS ABOUT ANALYSIS II; COMPENDIAL REQUIREMENTS FOR SOLLID AND SEMI-SOLID DOSAGE FORMS.

Compendia or Compendial References

Pharmacopoeias and formularies are collectively knows as?

Pharmacopoeias and Formularies

Compendia or Compendia References consists of?

Compendial References

Compendia is also known as?

• Official Compendia

• Unofficial Compendia

Compendia are dividend into two main types:

Official Compendia

This type of compendia, contains lists of drugs and related substances.

Official Compendia

This type of compendia, provides legal standards for purity, quality, and strength.

• Purity

• Quality

• Strength

Official Compendia provides legal standards for?

True

True or False: Official Compendia is approved and recognized by the government.

• United States Pharmacopoeia

• Japanese Pharmacopoeia

• British Pharmacopoeia

What are the three (3) examples of Official Compendia?

Unofficial Compendia

This type of compendia, contains similar information to official compendia.

False

(The Unofficial Compendia is not recognized by the government)

True or False: Unofficial Compendia is recognized by the government.

Remington’s Pharmaceutical Sciences

This unofficial compendia is often cited as unofficial reference.

• Remington’s Pharmaceutical Sciences

• Philippine National Drug Formulary

Give two (2) examples of unofficial compendia:

Tablets

These are solid dosage forms containing medicinal substances, usually prepared with suitable pharmaceutical exipients.

• Active Pharmaceutical Ingredient (API)

• Excipients (Binders, Lubricants, Disintegrants, and Diluents)

Tablets consists of:

• Binders

• Lubricants

• Disintegrants

• Diluents

Give four (4) examples of excipients:

Mnemonics: BL-DD

Compression or Molding

What are the preparation methods of tablets?

Scored or Grooved

PHYSICAL CHARACTERISTICS OF TABLETS:

What feature do some tablets have that allows them to be divided?

Broken into two or more parts

PHYSICAL CHARACTERISTICS OF TABLETS:

Why are some tablets scored or grooved?

Only for aesthetic purposes, to appeal to kids.

Why is it that other tablets may have decorative lines, but these are not recommended for splitting?

• Size

• Shape

• Weight

• Color

What physical characteristics do stable tablets retain under normal handling and storage?

In vitro availability

This availability of active ingredients should remain consistent throughout shelf life.

• Excessive powder or particles at container bottom

• Cracks or chips on tablet surface

• Crystals appearing on tablets or container walls

What are some signs of physical instability of medicines?

Friability Testing (USP <1216>)

This type of test evaluates resistance to abrasion.

Abrasion

Friability Testing evaluates resistance to?

• Mild shaking/tumbling

• Observe chips/cracks

• Weight intact tablets

What are the procedures in Friability Testing?

≤ 10% weight loss

What is the acceptable limit in Friability Testing?

Comparative

Friability testing results are considered what type of results?

Real-word stress

Friability testing results should correlate with what condition?

Shipping and drop tests

Packaged tablets are tested via?

Tablet Hardness Test

Resistance to crushing/fracturing.

Crushing or fracturing

Tablet Hardness Testing is to see the resistance to?

Hardness Testers

Tablet Hardness are measured with?

False

(Same tester must be used consistently for consistent results)

True or False: In tablet hardness testing, using of different instruments (inconsistent) doesn’t affect the results.

Color Stability

This is assessed with colorimeter or reflectometer.

Colorimeter or Reflectomer

Color Stability is assessed with what devices?

• Heat

• Sunlight

• Artificial Light

What factors accelerate color stability changes?

True

True or False: In color stability testing, visual assessment is common.

Same as room temperature

In color stability testing, degradation at high temperature is not equal to?

• Cracks

• Mottling

• Tackiness of coating

What are the three (3) signs of coated tablet instability?

Dissolution Testing

This test is primary in in-vitro test for availability.

In-vitro test

The dissolution test is considered the primary test for what type of availability?

Disintegration

In Dissolution Testing, this is equal to the in-process test, supports dissolution.

In-process test

In dissolution testing, disintegration is equal to what type of test that supports dissolution?

37 degrees celsius

Dissolution Test runs in appropriate medium at what temperature?

Clinical Phase

During which phase is the dissolution test developed?

Bioavailability

The dissolution test is developed to correlate with what?

• Immediate-release

• Controlled-release

• Unaltered dissolution profile

What are the three (3) Dissolution Profiles?

Immediate-release

This dissolution profile is a single sample time point with minimum concentration.

Minimum concentration

Immediate-release is a single sample time point with what concentration?

Controlled-release

This dissolution profile is a profile with concentration ranges at set sampling points.

Set sampling points

At what points are concentration ranges measured in a dissolution profile?

Unaltered dissolution profile

This dissolution profile is constant a in-vivo bioavailability.

In-vivo bioavailability

Unaltered dissolution profile is constant in what bioavailability?

• Weight

• Odor

• Texture

• Drug Content

• Moisture Content

What are the five (5) other stability parameters (uniformity of)?

Mnemonics: WOT-DM

True

True or False: Environmental and external effects are also studied.

Identity and Purity

COMENDIAL REQUIREMENTS: USP, JP, BP

Theses properties must match monograph; free from harmful impurities.

Harmful impurities

Drugs must be free from?

±5% of label claim

COMENDIAL REQUIREMENTS: USP, JP, BP

What is the % of strength/assay of label claim?

Uniformity of Dosage Units

COMENDIAL REQUIREMENTS: USP, JP, BP

Weight variation or content uniformity test.

Dissolution

COMENDIAL REQUIREMENTS: USP, JP, BP

Defined medium at 37 degrees celsius; time limits specified.

Disintegration

COMENDIAL REQUIREMENTS: USP, JP, BP

15-30 minutes for uncoated tablets.

15-30 minutes

How many minutes for the disintegration of uncoated tablets?

Packaging

COMENDIAL REQUIREMENTS: USP, JP, BP

Well-closed/tight containers; water-permeation tests when required.

Water-permeation tests

For the packaging of drugs, what tests is done when required?

Same

Same or Similar: USP, JP, BP Standards

• Identity

• USP: Must match monograph

Same

Same or Similar: USP, JP, BP Standards

• Assay (Strength)

• USP Standard: ±5% of label claim

Same

Same or Similar: USP, JP, BP Standards

• Uniformity

• Weight/content uniformity

Same

Same or Similar: USP, JP, BP Standards

• Dissolution

• USP Standard: Define medium at 37 degrees celsius

Similar

Same or Similar: USP, JP, BP Standards

• Disintegration

• USP Standard: 15-30 minutes (uncoated)

Similar

Same or Similar: USP, JP, BP Standards

• Friability

• USP Standard: ≤1% weight loss

Same

Same or Similar: USP, JP, BP Standards

• Packaging

• USP Standard: Well-closed/tight

Stability Testing & Compendial Requirements

These two (2) ensures tablets maintain quality, safety, and efficacy.

• Quality

• Safety

• Efficacy

Stability Testing + Compendial Requirements ensure tablets maintains?

USP, JP, and BP Standards

These three (3) standards are legally binding and critical for patient protection.