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Universidade Federal De Santa Catarina Centro De Ciências Da Saúde Programa De Pós-graduação Em Farmácia
| Content Provider | Semantic Scholar |
|---|---|
| Author | Tagliari, Monika Piazzon |
| Copyright Year | 2008 |
| Abstract | DEVELOPMENT AND QUALITY EVALUATION OF PHARMACEUTICAL SUSPENSIONS CONTAINING HYDROCHLOROTHIAZIDE. EVALUATION OF PEDIATRIC PATIENTS AT PEDIATRIC HOSPITAL JOANA DE GUSMÃO Hydrochlorothiazide (HCTZ) is a thiazide diuretic used in pediatric patients to treat hypertension and edematous diseases, although there isn’t a liquid pharmaceutical form commercially available. By this way, the aim of the present study was to develop and to do the quality control of pharmaceutical suspensions and to evaluate pediatric patients from the Pediatric Hospital Joana de Gusmão (HIJG) that received the suspension. It was carried out the physical-chemical characterization of HCTZ and polymers, in accordance with official literature, which proved their identity. The quantitative assay of HCTZ (raw material) obtained through chromatographic method was 99.8 % ± 0.6 % (n = 6), which indicates the purity of the sample. The water used to prepare the formulations was considered adequate after physical-chemical and microbiological characterizations. The suspensions containing 0.4 and 0.6 % of CMC-Na (F1 e F2) and 0.6 and 0.8 % of HPMC (F3 e F4) were prepared and analyzed like zeta potential, particle size, sedimentation volume, and redispersibility. The found values showed differences, depending of which polymer was used. The formulation F2 showed the best results, with zeta potential of -22.6 ± 1.6 mV, particle size of 44.1 μm ± 4.9, sedimentation volume of 0.11 mL ± 1.8 after 24 h and redispersion time of 13.3 s ± 2.3, which resulted in flocculated particles forming a loosely polymer network system. The formulations’ pH was corrected to 3.3, and they presented cloudy because of suspense particles, without odors and with characteristic acid flavor. In the viscosity analyze, all the formulations showed pseudoplastic and non-Newtonian behavior. Formulations F1 and F2 presented apparent viscosity (300 s e 25 °C) of 161.6 mPa.s ± 1.5 e 322 mPa.s ± 2.5, while formulations F3 and F4 presented values of 230.3 mPa.s ± 0.57 e 441.6 mPa.s ± 2.8, respectively. The flow behavior index was dependent of polymer concentration. The developed methodology for quantitative assay by CLAE was specific, linear, accurate, precise and robust in tested conditions. The quantitative assay of formulations F1, F2, F3 and F4 resulted in a range of drug content of 99.8 – 100.7 %. In the microbiologic characterization, all the formulations presented number of microorganisms < 10 UFC/mL and absence of pathogenic species. The challenge test was used to evaluate the preservative efficacy in the formulations F2 and F4. After 28 days, the challenged suspensions showed reduction of 90 % of all the pathogenic microorganisms tested. The accelerated stability studies showed that the formulations presented chemical degradation and fall of initial apparent viscosity with increase of temperature. The calculated shelf-life for F1, F2, F3 e F4 was 190, 188, 185 and 124 days, respectively, stored at ambient temperature at 25 °C. To evaluate the diuretic action of the HCTZ suspensions in rats, it was tested the formulations F2 and F4. The formulations containing HCTZ and the control solutions were administered to the animals in doses of 10 mg/kg and 10 ml/kg, respectively. The animals were kept in metabolic cages, and the urine was collected at the end of 8 h. It was observed an increase in urinary volume and electrolytes excretion (Na, K, Cl) in the animals that received treatment in comparison with control groups. The formulation F2 showed the best diuretic action in rats. This was used at clinical assay with pediatric patients from HIJG, where it was evaluated the diuretic effect and blood pressure. The dose of HCTZ administered was dependent of medical prescription. The evolution of treatment/efficacy was satisfactory, reaching normal pressure levels in relation with height, weight, age and sex, and an increase in patients’ diuresis. The formulation F2 was chosen in this study because of it was more stable and its clinical effectiveness was proved. |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | https://repositorio.ufsc.br/xmlui/bitstream/handle/123456789/91315/249942.pdf;jsessionid=8EB6D050253E2753CD0ABC495D29907D?sequence=1 |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
