Solid oral drug products

Chapter 1146 Packaging Practice—Repackaging a Single, Solid, Oral Drug Product into a Unit Dose Container... 

Zhang, H. and Yu, L. X., Dissolution testing for solid oral drug products theoretical consideration, Am. Pharm. Rev., 5, 26-31, September 2004. 

A combination of these approaches has utility for better characterizing the dissolution profile of low-dose solid oral drug products. 

REGULATORY CONSIDERATIONS IN THE DEVELOPMENT OF LOW-DOSE SOLID ORAL DRUG PRODUCTS... 

The slowest step in a kinetic process is the rate-limiting step. Except for controlled release products, disintegration of a solid oral drug product is usually... 

Biopharmaceutic classification (BCS) system Immediate release solid oral drug products Drug must be a highly soluble and highly permeable substance that is in a rapidly dissolving dosage form... 

Rapidly dissolving products An immediate-release solid oral drug product is considered rapidly dissolving when not less than 80% of the label amount of the drug substance dissolves within 15 minutes in each of the following media (1) pH 1.2, (2) pH 4.0, and (3) pH 6.8. 

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