Oral solids

Pharmaceutical Engineering Guides for New Facilities , 1998, Vol. 2, Oral Solid Dosage Forms, ISPE/FDA, February. 

The USP is continuing to seek other materials for which acceptable criteria for interchangeability can be established. These include polypropylene for dry, oral solids and ophthalmic liquid products. Additional criteria may be established for substituting replacement resins for closures. 

Various dissolution test systems have been developed and several of them now enjoy compendial status in pharmacopeias, for example the reciprocating cylinder (United States Pharmacopeia Apparatus 3), the flow-through apparatus [European Pharmacopoeia (Pharm. Eur.) 2.9.3], or the apparatus for transdermal delivery systems, such as the paddle over disc. Hydrodynamic properties of these and other apparatus have been described only sparingly. The paucity of quantitative data related to hydrodynamics of pharmacopeial dissolution testers is lamentable, since well-controllable hydrodynamics are essential to both biopharmaceutical simulations and quality control. Here, we focus the discussion on the paddle and the basket apparatus, since these are the most important and widely used for oral solid dosage forms. A brief treatise on the hydrodynamics of the flow-through apparatus completes this section. 

Part IB Specific requirements for manufacture of oral solid dosage forms (tablets and capsules)... 

Another example of an excipient-excipient interaction that can be used to our advantage is the one between xanthan gum and locust bean gum (carob gum or cer-atonia) in the presence of water. This interaction forms the basis of the identification test for Xanthan Gum NF. The interaction creates a much more viscous gel system than can be created using either component alone. This has been used in the formulation of controlled release oral solid dosage forms in the TimeRx drug delivery system (11). 

The extent of drug release from oral solid formulations is determined by the dissolution rates of drug, which is a function of aqueous solubility and particle sizes as shown in the following equation. 

The use of biodegradable polymers, especially polylactic acid (PLA), in oral solid dosage forms has been reported in the literature. PLA has been used as a matrix for phenobarbital tablets (9). Similarly, the use of polylactide as a matrix for oral dosage form of naproxen has also been reported (10). 

AAPS/FDA. Scale-Up of Oral Solid Dosage Forms. December 11-13, 1991. 

Skelly. J. P., Van Buskrik, G. A., Savello, D. R.. et al. Workshop report scale-up of immediate release oral solid dosage forms. Pharm. Res. 10 313-316, 1993. 

See Workshop Report Scale-up of Immediate Release Oral Solid Dosage Forms, Pharmiceutical Research, 10 12) 313-316, Skelly et al and Federal Register, Vol, 59, No, 183. Thursday, September 22.1994. pages 48754—59. 

Cannon, J. (2005) Oral solid dosage forms of lipid-based drug delivery systemSharm. Rey8 108-113. 

Shin, H.-J., J.-K. Park, J.-W. Kim, E.-J. Lee, and C.-K. Kim. 1996. Preparation and bioequivalence test of new oral solid dosage form of cyclosporin Aroc. Int. Symp. Controlled Release Bioact. Mater. 23 519-520. 

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