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,.
Microsponge, a novel drug delivery system, is designed to deliver a pharmaceutically active ingredient efficiently at the minimum dose. Microsponge plays an important role in enhancing drug stability, reducing side effects, and modifying drug release profiles. It is mostly used for transdermal delivery. Recent studies also explored their use for oral administration. This study aimed to explore the potential use of the microsponge technique in improving the aqueous solubility and dissolution profile of pentoxifylline (PTX). In this study, microsponges were prepared by a quasi-emulsion solvent diffusion method by varying concentrations of carriers. Nine different ratios of the PTX:Eudragit E-100 with varying amounts of dichloromethane were used. All formulated microsponges were evaluated for %production yield, compatibility of drug excipient, encapsulation efficiency, in vitro drug release, and in vivo bioavailability, as well as recorded by scanning electron microscopy (SEM) and differential scanning calorimetry(DSC). Our data suggested that the aqueous solubility of PTX microsponges was four times greater than that of pure drug. The in vitro drug release of selected microsponges (M8) was found to be 70%; furthermore, the in vivo study suggested that the selected formulation significantly enhanced drug concentration in the plasma (9,219 ng/mL in 12 hours) in comparison to pure drug PTX (2,476 ng/mL in 12 hours). SEM showed that the prepared microsponges were spherical with porous nature. Fourier-transform infrared spectroscopy and DSC studies confirmed an absence of incompatibility among drugs and selected excipients. The pH of the selected gel was found to be 6.8, which was compatible with those of skin and oral formulations also. All above data suggested a highly successful and beneficial use of the microsponge technique in enhancing aqueous solubility, dissolution profile, and oral bioavailability of PTX. Microsponge-based delivery of PTX may represent an alternative strategy to improve the bioavailability of the drug.
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