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THE PHARMA REVIEW (SEPTEMBER OCTOBER 2012)

Importance of Moisture Content for Manufacturing of Solid Drugs Formulations

Anuja Ramesh Mahadik

Introduction:
 
Moisture plays a key role in physical and chemical stability of solid dosage formulation. Care during manufacturing and selection of protective packaging can reduce the products exposure to moisture; however it is preferable to select components of drugs which minimize the moisture sensitivity of the product. It becomes necessary to know the moisture content of the substance.
Water found in the matrix of the drug is generally classified as either mobile or immobile. Mobile water sometimes called unbound or free water is loosely adsorbed on the surface of the solid. Immobile water is either:
1. Hydrated water in the crystalline structure
2. Linked by the hydrogen bonding
3. Sorbed (water by adsorption or absorption) or entrapped within the amorphous structure

Although the degree of the bonding may vary significantly, immobile water is generally perceived as not readily available for the chemical interaction with other species. Alternatively mobile water is readily available for chemical reactions. Thus it’s the amount of mobile water rather than the amount of total water that is critical to the stability of the drug.

 

 

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