Disintegration refers to the dissolution or fragmentation of oral solid preparations under specified conditions, except for insoluble coating materials or broken capsule shells, which should all pass through the screen (if a small amount cannot pass through the screen, but has been softened or light floating on the surface and no hard core can be considered as conforming to the regulations).
Disintegration is one of the quality inspection items for solid drugs. After oral administration of solid preparations, they need to disintegrate before they can be absorbed by the body for therapeutic purposes.
Our Services
Alfa Chemistry is an industry-leading pharmaceutical service company. We are committed to providing one-stop service from research and development to application for generic drug customers, which can effectively help shorten the product development cycle and accelerate entry into the market.
Disintegration is mainly used for the examination of easily soluble drugs, and the degree of dissolution is usually checked for poorly soluble drugs. For products for which dissolution determination has been carried out, disintegration determination can be omitted. Disintegration is an important indicator for drug performance evaluation, and generic drugs should have similar disintegration to RLD. Alfa Chemistry's technology platform not only includes dissolution method establishment and validation services, but also provides disintegration testing services to help generic drug manufacturers conduct rational and efficient formulation process research.
Disintegration of solid preparations is a prerequisite for drug dissolution and absorption by the body. Disintegration, as a measure of the disintegration rate of a drug in the human body, is generally measured by the disintegration time limit. Testing methods for disintegration time limits are described in the EP, USP, ChP and other national pharmacopeia. The usual test is to immerse the tablet or capsule in a defined volume of simulated gastric juice to determine the time required for its disintegration into an invisible residue, as assessed by trapping material on a screen.
Significance of determination of disintegration degree
The main factors affecting the disintegration of solid preparations are the nature of raw materials, composition of prescription, production technology, variety and dosage of disintegrant, etc. The significance of measuring the degree of disintegration of solid preparations includes:
- Prescription for screening preparations
- Guide the process development and optimization of formulation
- Control the intrinsic quality of solid preparations
- To evaluate the in vivo bioavailability of oral solid formulations
Our method for determining disintegration
Our automated disintegrator accurately determines the disintegration of generic drugs and RLD, thus helping to control the quality of the product.
The automatic disintegrator we used consists of a reciprocating drive system, a water bath, a heater/circulator, and no other accessories. The principle of our test follows the pharmacopoeia standards of various countries, and has a fully programmable operation mode to test three batches of samples at the same time. Working with our technology platform, you will quickly get reliable, complete and highly reproducible data.
What products do we test
Tablets
- Oral tablets
- Film-coated tablets
- Sugar coated tablets
- Enteric-coated tablets
- Colonic localization enteric-coated tablets
- Lozenge
- Sublingual tablet
- Effervescent tablets
Capsules
- Hard capsule
- Soft capsule
- Enteric-coated capsules
