The aim of present work was to characterize Clarithromycin (CLT), Polyvinyl pyrrolidone K30 (PVP K30) and Hydroxypropyl β-cyclodextrin (HPB) ternary system so as to check the effect of complexation on solubility of CLT. Physical mixtures of a drug and polymers in several weight ratios (1:1, 1:2) were prepared to check the effect of individual polymers on solubility of CLT. Spray drying method was accustomed investigate the combined effect of PVP K30 and HPB on Drug release (DR), Dissolution efficiency (DE) and mean dissolution time (MDT) of CLT. For the preparation and optimization of ternary system the Design of experiment (DoE) was used . Drug polymer interactions were analyzed with Fourier transform infrared spectroscopy (FTIR), Differential scanning calorimetry (DSC), X-ray diffraction (XRD) and particle size analysis. Results of solubility study suggested that there was significant increase in solubility of CLT with increase within the concentration of PVP K30 and HPB (*p<0.05). This may be thanks to the solubilizing effect of PVP K30 and sophisticated formation of CLT with HPB. Various combinations of PVP K30 and HPB prepared using DoE approach by spray drying method showed greater solubility of CLT than its physical mixtures (*p<0.05). Results of FTIR, DSC, XRD and particle size analysis revealed the interaction between CLT, PVP K30 and HPB. This suggested formation of amorphous ternary system with mean particle diameter within the range of 312±1.35 nm. Combine use of PVP K30 and HPB with DoE approach was an efficient tool for formulating ternary system of CLT. Keywords: Clarithromycin, Spray drying, polyvinyl pyrrolidone K30, Hydroxypropyl β-cyclodextrin, Design of experiments, Ternary system.
The manufacturing process of the tablet is a very complex process; it can be affected by the several process parameters or variables. The aim of this study was to understand and optimize the process parameters such as mixing, granulation, lubrication and tablets compression processes using quality by design (QbD) approach for a model Anti- Hyperlipidemic drug Fluvastatin sodium. During the processes there are several parameters which may influence or affect product quality. So the main objective of present work was to identify various process parameters and optimize this parameter, for the formulation of good quality product which needs to optimize Blending time, Roller force, Compression force and machine speed. A scale up batch was taken to evaluate and optimize the parameters. Critical quality attributes (CQA) such as flow behavior, granules parameters, Blend uniformity, tablet appearance, effect on tablet quality like physical appearance (surface, weight etc.) and tablet dissolution time as well as drug release. The test results of following parameters at various in-process phases are complies with the specified limits and finished product sample results were found to be within specified limits. This study results assures the manufacturing process is reproducible, robust and will yield consistent product, which meets specification. Keywords: Process Parameters, Quality by Design, Fluvastatin, Granulation, Blending, Compression etc,.
Background: Microsponge is a class of dosage form containing porous nature containing drug that is targeted to achieve sustained action for prolong period. Microsponge based delivery system results in drug localization on skin surface and in epidermis without moving in systemic circulation to higher extent. Methods: Present study aims to formulate the microsponge containing celecoxib by quasi emulsification solvent diffusion method. Prepared formulations were evaluated for particle size, % entrapment efficiency, production yield, surface morphology, etc. Results: Formulation F1 and E2 were considered as optimized formulation having drug loading 91±4.2 % and 91±3.1 % respectively. FTIR spectroscopy analysis indicated the chemically stable, crystalline nature of the drug in these microsponges. Small change in crystallinity of pure drug was observed in XRD study. SEM study shows good microsponge surface appearance with pores on surfaces. Average particle size of optimized microsponge formulation F1 is found to be 48 µm while E2 formulation gave microsponges with particle size of 33.7 µm. As the RPM was increased the microsponge's size was also decreased and formed microsponges were spherical and is having uniform nature. Conclusion: Finally it can be concluded that chemically stable, uniform and porous microspheres were formed using Eudragit L-100 and Ethyl cellulose.
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