Effects of Prosochit® Binder on the Dissolution and Permeation of a BCS Class IV Drug doi.org/10.26538/tjnpr/v5i6.26
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Abstract
Prosochit® (PC) is a novel excipient available in variants: Prosochit® 201, 101 and 102 having varying binding and performance-modifying properties. This study investigates the effects of the different types of Prosochit® on the dissolution and permeation of hydrochlorothiazide, a BCS class IV drug. Compatibility of Prosochit® with hydrochlorothiazide was investigated using Fourier Transform Infrared Spectroscopy (FTIR). Six batches of hydrochlorothiazide tablets were formulated by wet granulation; batches F1 to F3 containing 3% PC201, PC101 and PC102 respectively and batches F4 to F6 containing 6% PC201, PC101 and PC102 respectively. The release properties of the tablets and the intestinal permeability of the drug were studied in comparison with a marketed product. The FTIR spectra revealed no adverse interaction between Prosochit® and hydrochlorothiazide. The cumulative amount of drug released in 1 h was in the order: marketed product > F1 > F2 > F6 > F3 > F5 > F4. Even though the test tablets exhibited low dissolution rates, substantial amounts of the drug were eventually released after 1 h to enable adequate permeation of the drug. The test tablets were characterized by better permeation profiles compared to the marketed product; and batch F1 which contains 3% PC201 was characterized by a markedly high amount of drug permeated in 5 h. Of the Prosochit® types and concentrations investigated, 3% PC201 is the most suitable binder for optimizing the dissolution and permeation of hydrochlorothiazide.
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