Excipients solid drug products

Table 5 Common excipients used in solid drug products...

When the excipient matrix in a formulation is largely amorphous, similar XRPD methods can be used to determine the amount of crystalline drug substance present in a drug product. The principles were established in a study that included a number of solid dose forms [40],... 

Solids Solid dosage forms are the most common means for presenting the drug product for patient administration. Most APIs are in crystallized or powder forms. They are ground to predetermined sizes using mills or pulverizers. The APIs and excipients are then mixed using blenders or tumblers. 

A preservative is a substance that prevents or inhibits microbial growth and extends the shelf life of the drug products. In most pharmaceutical drug products, only a few compounds are typically selected as preservatives. For efficiency, a generic method should be developed for the types of preservatives that are more commonly used. For example, butylated hydroxytoluene (BHT) is an antioxidant commonly used in many solid dosage formulations to retard oxidative degradation of the excipients. 

AN EXCIPIENT LIBRARY APPROACH TO ANALYTICAL DEVELOPMENT FOR LOW-DOSE, SOLID ORAL DOSAGE FORM DRUG PRODUCTS... 

A special consideration must be given to the effect of water on a given drug product (or a formulation). Water presents a real problem for a formulation when the drug substance or the excipients are sensitive or susceptible to hydrolysis. Whether the excipients will dissolve in certain solvents or not, their interactions with the active (in solution and solid state) are very important. 

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