Aim: The objective of preformulation study is to develop the elegant, stable, effective and safe dosage form by establishing kinetic profile, compatibility with other formulation excipients and physico-chemical parameters of new drug substance. This could provide important information for formulation design or support the need for molecular modification. So, in the present study preformulation studies were performed on Glimepiride (GMP) to assess its suitability for parenteral formulation. Glimepiride is the first IIIrd generation sulphonyl urea used to treat type –II diabetes mellitus.
Methods: The authenticity of GMP was established by DSC and FTIR spectra. A UV spectrophotometric method and HPLC method were employed for determination of GMP in bulk active pharmaceutical ingredient (API).
Results: The UV method was linear in the range of 3-10 μg/ml. The low % CV values of intra-day and inter-day variations revealed that the proposed method is robust. The retention time of GMP in HPLC method was found to be 1.9 min. The method was proven robust by obtaining very high regression coefficient value (0.999).
Conclusions: The results of the physicochemical study of drug revealed suitability of GMP for parenteral route. Moreover, the drug was found stable in both solid as well as liquid state at different conditions.
Although fungus being part of the commensal skin micro-structuring, various pathogenic commensals colonizes on human skin leading to superficial fungal infections. Owing to the resistance of present therapeutic treatments available, microbial resistance and serious hypoallergic reactions have been a concern to explore the phyto-therapeutic nutrients for treatment of fungal infections. One such plant essential oil-based formulation is thyme oil derived from the leaves of thymus vulgaris. The aim of present work i.e. development of thyme oil based microemulsion for treatment of fungal infections due to candida and trichophyton species. The thyme oil loaded microemulsion based gel was constructed using D-optimal design and the optimized final formulation contains 0.82% of oil, 9.22% of Smix and 89.95% of water. The optimized microemulsions was pale yellow to amber transparent microemulsion with globule size of 14.23 ± 0.3 nm, zeta potential of -0.69 mV and PDI value 0.00143 indicating a stable microemulsion. The microemulsion based gel formed had a pH of 6.03, appreciable viscosity and rheological properties. The drug release of formulation was 100.0 ± 0.22%. The % of drug permeated in skin layers was found to be 15.53 ± 0.22%. While % drug retention on the skin surface was found to be 26.32 ± 0.26% and within skin layers was found to be 58.47 ± 0.22%. The microemulsion based MBG was found to be safe on the dermis and efficacious then the marketed product and hence, promises its utilization as a safe and efficacious formulation for treatment of dermal infections.
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