To evaluate effect of moisture on emdex at different temperatures.

摘要

Emdex is manufacture by hydrolysis of starch which is available as direct compressible diluent and binder. Moisture plays negative role in pharmaceutical dosage form. Moisture affects physical property of some drugs. Initial moisture content and inherent tendency of active ingredient as well as pharmaceutical excipient to absorb moisture from surrounding environment affect physical property of tablet. The effect of moisture absorption on stability of tablets studied previously. Different drugs and excipients have different hygroscopic property. Hygroscopic nature of active ingredient and excipient should be considered in formulation because amount moisture absorbed by excipients and drugs can not affect only their own properties but also effect final dosage form. The hygroscopicity of excipients studied. For emdex as increase relative humidity during storage time moisture content will increase it affect its flow rate, bulk and tapped density. Hygroscopic materials are more sensitive to moisture uptake than non-hygroscopic materials. Moisture sensitive drug should not be combined with moisture sensitive drug. The presence of moisture in tablet dosage form is also responsible for drug degradation due to moisture sensitive active ingredient. Interrelationship among high moisture and temperature on hardness, disintegration time, dissolution in compressed tablets were studied earlier. The moisture content of the tablet at the time of compression and moisture gain from surrounding atmosphere plays a significantly important role on hardness and disintegration time. The large difference in tablet hardness between dextrose monohydrate and anhydrous dextrose at same moisture content due to different manner in which water is held and difference in mobility of water. Tablet hardness of monohydrated form was found less because the water of crystallization is locked into the crystalline structure and is not available to encourage bond formation. Whereas in anhydrous form, moisture exists in free form which is responsible for lubrication, dissolution and subsequent recrystallization of the solid on compression. Hardness of tablets depends on initial moisture level, tablets with high moisture content were found to increase in hardness upon storage. The magnitude of such increase is depending upon the physical properties of the base and the absolute moisture content. Tablets with low initial moisture content were minimally affected by storage.