AI Article Synopsis
- Hydrochlorothiazide is a diuretic used to treat high blood pressure and is classified as a Class IV drug according to the Biopharmaceutics Classification System.
- The evaluation of the drug involved quality control, thermal characterization, and compatibility studies, revealing that a specific generic version (Lab 2) was not equivalent to the brand.
- The study also found that certain excipients, like lactose and mannitol, were incompatible with HCTZ, contributing to the lack of equivalence in the generic product.
Article Abstract
Hydrochlorothiazide is a diuretic used to treat hypertension that belongs to class IV of the Biopharmaceutics Classification System. The drug was evaluated by quality control, thermal characterization tests, and pharmaceutical formulation compatibility studies. It was concluded that the generic drug, Lab 2, was not a pharmaceutical equivalent. The compounded drugs, Lab 5 and Lab 6, produced unsatisfactory but expected results, since there is no requirement for dissolution and dissolution profile testing for the commercialization of these products. In a compatibility study, lactose and mannitol were shown to be incompatible with HCTZ, which may explain the lack of equivalence of the generic pharmaceutical product, associated with other situations.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6271651 | PMC |
| http://dx.doi.org/10.3390/molecules191016824 | DOI Listing |
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