Development of a controlled-released formulation of chlorpheniramine maleate is described, using in vitro/in vivo correlates, according to a process that has been termed "biorelevant dissolution". The process begins with simulations using several possible input rates combined with known disposition
THEOPHYLLINE CONTROLLED-RELEASE FORMULATIONS: IN VIVO--IN VITRO CORRELATIONS
โ Scribed by Zhiling Yu; Joseph B. Schwartz; Edwin T. Sugita
- Publisher
- John Wiley and Sons
- Year
- 1996
- Tongue
- English
- Weight
- 647 KB
- Volume
- 17
- Category
- Article
- ISSN
- 0142-2782
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โฆ Synopsis
Four experimental controlled-release oral solid dosage formulations were developed and the in vitro dissolution characteristics of theophylline from these formulations were studied in USP apparatus I. Pharmacokinetic evaluation of these formulations was carried out in eight beagle dogs under fasting conditions. Theophylline in a 5% dextrose injection USP, oral solution, and Slo-Phyllina were used as controls to estimate the in vivo dissolution of these four formulations in the GI tract. The percentage cumulative amounts of drug absorbed and the percentage cumulative amounts of drug released into the GI tract from these four controlled-release formulations were obtained by numerical deconvolution methods. The in vivo and in vitro dissolution data demonstrated good correlation indicating that in vitro dissolution tests can be used to optimize the further design of controlled drug release oral solid dosage formulations for theophylline.
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## Abstract An __in vitro__โ__in vivo__ correlation (IVIVC) was established for an osmotic controlledโrelease dosage form by deconvolution using data from an immediateโrelease treatment as the characteristic response. The established IVIVC was evaluated internally (predicting data used to develop t
The bioavailability and pharmacokinetics of salicylic acid (SA) were studied after single and multiple doses of a new slow-release formulation, based on porous membrane diffusion of sodium salicylate (NaSA). A solution of NaSA and an enteric-coated tablet of NaSA were used for comparison. Dissolutio