1. Quality Control Requirement
HHV 5014
NUTRACEUTICAL FORMULATION
Quality Control Requirement
LECTURER: SIR NOOR MOHD SYAHRIN
STUDENTS: AFIQ
NINA
SYAHMI

2. Definition
Quality: The status of a drug that is determined by identity, purity, content, and other chemical, physical, or biological properties, or by the manufacturing processes Quality Control: Is a product oriented and focuses on defect identification

3. Quality Control of Tablets
General Appearance:
Size,
shape
Thickness
This is important to facilitate packaging and to decide which tablet compressing machine to use.
Organoleptic properties:
color
odor

4. BRITISH PHARMACOPOEIA
Uncoated tablet:
Disintegration test
Uniformity of weight
Effervescent tablet:
Coated tablet:

5. Gastro resistant tablet:
Disintegration test
Modified release tablet:
Uniformity of weight.
Dispersible tablet:
Uniformity of dispersion
Uniformity of weight

6. INDIAN PHARMACOPOEIA Uncoated tablet: -
Uniformity of container content
Content of active ingredient
Uniformity of weight
Uniformity of content
Disintegration test
Enteric coated tablet:
SINENSITIN

7. Uniformity of dispersion Disintegration
Dispersible tablet:
Uniformity of dispersion
Disintegration
Soluble tablet:
Disintegration test
Effervescent tablet:
Disintegration/ Dissolution / Dispersion test

8. UNITED STATES PHARMACOPOEIA
Physical tests applicable to tablet formulation:-
Bulk density /Tapped density of powder
Powder fineness
Loss on drying
Disintegration test
Tablet friability
Dissolution test
Drug release testing
Uniformity of dosage form
Container permeation test
Labelling of inactive ingredients

9. Official and unofficial tests
Weight variation
disintegration
dissolution
drug content
Non-Official Tests:
Hardness
friability

10. Non official tests
Hardness (crushing strength): It is the load required to crush the tablet when placed on its edge.
Why do we measure hardness?
To determine the need for pressure adjustments on the tableting machine.
Hardness can affect the disintegration. So if the tablet is too hard, it may not disintegrate in the required period of time.
If the tablet is too soft, it will not withstand the handling during subsequent.

11. Factors Affecting the Hardness:
Compression of the tablet
compressive force.
Amount of binder. (More binder à more hardness)
Method of granulation in preparing the tablet (wet method gives more hardness than direct method, Slugging method gives the best hardness)
Limits:
5 kilograms minimum
8 kilograms maximum

12. Procedure... Make hardness test on 5 tablets
Then take the average hardness.

13. Friability: It is the tendency of tablets to powder, chip, or fragment and this can affect the elegance appearance, consumer acceptance of the tablet, and also add to tablet’s weight variation or content uniformity problems Friability also is a property that is related to the hardness of the tablet. An instrument called friabilator is used to evaluate the ability of the tablet to withstand abrasion in packaging, handling, and shipping.

14. Quality Control of Capsules
BRITISH PHARMACOPOEIA
TEST:
disintegration of capsules
Uniformity of Weight of capsules