Background: Solid dispersion technology, stabilizes amorphous. I need crystal form in the final drug product. Can someone suggest strategies to stabilize crystalline form(technology should not transform unit cell geometry after the manufacturing of drug product)
Dear Vijay,
Before designing a drug product with stable cryatalline form following information is to be considered
Condition required to maintain the cryatalline form. If it is very unstable, need to find out the required conditions for form transformation and the mechanism of form transformation.
Solution 1: If possible, select the manufacturing pocesses where the conditions for the form transformation is not involved.
Solution 2: If tme mechanism of form transformation understand clearly, please find out some addititive that could inhibit the process.
Regards
Srimanta
Drug stability can be equated to the capability of a particular drug formulation in a specific container to remain within a particular chemical, microbiological, therapeutically, physical & toxicological specification in a specified period of time.
For the purpose of stabilizing the crystalline form of a drug, the physicochemical degradation processes in pharmaceutical products that may contain such drug entities must be controlled or prevented.
1. Physical variables such as:
- Loss of volatile components
- Loss of water
- Absorption of water
- Crystal growth
- Polymorphic changes
- Color changes
- etc
2. Chemical variables such as:
- Hydrolysis,
- Oxidation,
- Decarboxylation,
- Photolysis.
- etc
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