Unibrol USP 250 mg Tablets called for quarantine
- 2021-01-18 14:44:11
The complete disintegration does not imply the complete dissolution of dosage unit or active pharmaceutical ingredient (API).
The disintegration test prescribes the time required for solid pharmaceutical dosage form (tablet, capsules, granules and pills) to break completely into small particles when it is immersed into medium fluid at a certain condition.
The complete disintegration does not imply the complete dissolution of dosage unit or active pharmaceutical ingredient (API). According to United States pharmacopoeia the complete Disintegration is defined as that state in which:
ü no residue of the tablet or capsule remains on the screen of the apparatus,
ü If a residue remains, it consists of fragments of insoluble coating of the tablets or of capsule shells or is a soft mass with no palpable core. If discs have been used with capsules, any residue remaining on the lower surface of the discs consists only of fragments of shells.
Condition for disintegration
I. Disintegration Media
The type and quantity of liquid medium used during the disintegration test different from one to another. It may be water, acid or buffer depending on the type of tablet or capsules to be disintegrated. For example the medium used during the analysis of uncoated tablet will be different from the medium for enteric coated tablet
Before stating the apparatus, the temperature of liquid medium must be raised up between 35 and 390C except dispersible, effervescent and soluble tablet where the medium temperature must belongs between 15 and 250C
The use of discs depends on dosage form to be tested and they are allowed only where specified.
ü Turn on disintegration apparatus
ü Raise up the temperature of liquid medium inside the beaker between 35 and 39 °C.
ü Place one dosage unit in each of the six tubes of the basket and if specified add a disc.
ü Operate the apparatus in prescribed time
ü At the end of the specified time lift the basket from the fluid and observe the dosage units
Acceptance Criteria for disintegration:
All of the dosage must disintegrate completely in specified time. If one or two dosage units fail to disintegrate repeat the test on 12 additional dosage units. The requirements of the test are met if not less than 16 of the 18 dosage units tested are disintegrated
1. International pharmacopoeia; 5.3 Disintegration test for tablets and capsules; 10th Edition, 2020.
2. British pharmacopoeia; 1. Disintegration of Tablets and Capsules, 2022
3. United States Pharmacopeia Convention. Disintegration. In United States Pharmacopeia and National Formulary (USP 43-NF 38); United States Pharmacopeia Convention: Rockville, MD, USA, 2019.
4. Council of Europe, 2.9.1. Disintegration of tablets and capsules. In European Pharmacopoeia, 10th Edition. Council of Europe: Strasbourg, France, 2021.
5. Society of Japanese Pharmacopoeia, 6.09. Disintegration test. In The Japanese Pharmacopeia, 17th Edition. Society of Japanese Pharmacopoeia: Tokyo, Japan, 2021.