Dosage forms study factors

A rational way to develop approaches that will increase the stability of fast-degrading drugs in pharmaceutical dosage forms is thorough study of the factors that can affect such stability. In this section, the factors that can affect decomposition rates are discussed it will be seen that under certain conditions of pH, solvent, presence of additives, and so on, the stability of a drug may be drastically affected. Equations that may allow prediction of these effects on reaction rates are discussed. 

Smell, taste, texture, and aftertaste, therefore, are important factors in the development of pediatric dosage forms. In a study of six brands of OTC chewable vitamins, flavor type and intensity, soft texture, and short aftertaste were critical factors in product preference. The flavor and texture attributes of the bestselling product were significantly different from the other brands [97]. 

Biopharmaceutics is the study of factors influencing the extent and rate of absorption and release of a drug from its various physicochemical properties and dosage forms and the therapeutic response obtained after its administration. 

Not every drug product is susceptible to degradation by all of these factors not all drug products are fight sensitive. Not all tablets are subject to loss of quality caused by absorption of moisture. Sensitivity to oxygen is most commonly found with liquid-based dosage forms. Laboratory studies can be used to determine which of these factors actually have an influence on a particular drug product. 

When requesting a BCS-based waiver for in vivo BA/BE studies for IR solid oral dosage forms, applicants should note that the following factors can affect their request or the documentation of their request ... 

Stability of the polymers at usual storage conditions depends on their molecular structure. Several studies have documented that methacrylic acid copolymers are the most stable polymers as bulk and finished dosage form (Figure 3) [24], The limiting factor of stability of the polymers is their ester function, which tends to... 

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