Current Issue : July - September Volume : 2016 Issue Number : 3 Articles : 5 Articles
This review focused on the existing circumstances of quality by design (QbD) implementation in pharmaceutical industry and regulatory bodies. QbD is a systematic approach to improve the quality of product by optimizing the process using defines variables, experimental designs, statistical principles and gives predicted reliable results. Hence this was an attempt which overview the adoption and execution of QbD principles in the development of pharmaceutical product. This review stands on comprehensive search of most relevant industry and regulatory articles, publications and web resources. The main focus of this work was on the essentials, challenges and current scenario for QbD application in all pharmaceutical organizations. It was observed that perceptions towards QbD approach immensely vary among pharma industries and also in the regulatory authorities. Current situation of QbD implementation demands more collaborative work, discussions and interactions. This could help to improve the performance of QbD approach in pharma industry. It also evaluates the QbD adoption challenges of biological products, new drug and abbreviated drug products with some examples. It outlines the understanding and application challenges of QbD approach in organizations and reveals the recent investigations and achievements in this exciting area....
Formulating ezetimibe in oral solid preparation has challenged oral hyperlipidemia therapy with ezetimibe. The present work was about formulating a solid self-microemulsifying formulation of ezetimibe and evaluating its in-vitro preparation. The solubility of ezetimibe was determined in various vehicles. Ezetimibe was dispersed with a surfactant used for the self-microemulsifying drug delivery system (SMEDDS), Tween 20, cremophor, peceol and mixture was solidified with maltodextrin. Solid-SMEDDS is prepared using maltodextrin as solid carrier and characterized for drug content, spray dried process yield and flow property which was 91.4%, 56% respectively with good flow property. Saturation solubility of solid SMEDDS shows 93 folds increased solubility. Dissolution studied in 0.1 N HCl and phosphate buffer 7.4 provide higher drug release 82.32% within 15 min compared with marketed formulation. Solid state characterization of solid-SMEDDS shows that the drug is in amorphous form. For improved patient compliance and onset of action oral dispersible tablet was prepared and evaluated. The present research shows that S-SMEDDS is an ideal and promising approach to enhance the solubility and its oral dispersible tablet increase patient compliance. The optimized formulation was then subjected to stability and was found to be stable over three months. It has been found that dissolution profile of ezetimibe from SMEDDS was much improved than ezetimibe....
Solid-self-emulsifying drug delivery system (S-SEDDS) of paclitaxel (Ptx) was developed by the spray drying method with the\npurpose of improving the low bioavailability (BA) of Ptx. 10% oil (ethyl oleate), 80% surfactant mixture (Tween 80 : Carbitol, 90 : 10,\nw/w), and 10% cosolvent (PEG 400) were chosen according to their solubilizing capacity.Themean droplet size, zeta potential, and\nencapsulation efficiency of the prepared S-SEDDS were 16.9 �± 1.53 nm, 12.5 �± 1.66mV, and 56.2 �± 8.1%, respectively. In the S-SEDDS,\nPtx presents in the form of molecular dispersion in the emulsions or is distributed in an amorphous state or crystalline with very\nsmall size. The prepared S-SEDDS formulation showed 70 and 75% dissolution in 60 and 30 min in dissolution medium pH 1.2\nand 6.8, respectively. Significant increase (...
Solubility is an important physicochemical factor which affects absorption of drug and low dissolution rate in aqueous G.I.T fluid often leads to insufficient bioavailability. In the present work, an attempt was made to improve the solubility and dissolution rate of a poorly soluble drug valsartan (BCS class II) by solid dispersion method using soluplus polymer as a solubilizing agent. The formulation was prepared using drug: polymer ratios 1:1, 1:2 and 1:3 by melt extrusion method. The solubility study was carried out to find out best solubility ratio. The VAL: Soluplus ratio 1:3 shows maximum solubility in pH 1.2, pH 6.8 and pH 7.4 phosphate buffer. I.e. VAL possesses pH dependent solubility. The pure drug valsartan and prepared solid dispersion (1:3) were characterized by scanning electron microscopy (SEM), differential scanning calorimeter (DSC), fourier transform infrared spectroscopy (FT-IR), X-ray diffraction analysis (XRD), % drug content and in-vitro dissolution studies. The drug content of pure drug VAL in the polymer matrix of soluplus was obtained 53.16%. The in-vitro drug release study of solid dispersion shows improvement in drug release (i.e. 57.35%) as compared to pure drug valsartan (42.68%) within 120 min in phosphate buffer pH 6.8. The improvement in solubility and dissolution behavior of drug valsartan was due to amphiphilic structure of soluplus formed micelles in aqueous solution....
Background: Due to antibiotic treatment of humans and animals, the prevalence of bacterial resistances increases\nworldwide. Especially in livestock farming, large quantities of faeces contaminated with antibiotics pose a risk of the\ncarryover of the active ingredient to the environment. Accordingly, the aim of the present study was the evaluation\nof the benefit of different oral dosage forms (powder, pellets, granula) in pigs concerning the environmental pollution\nof sulfadiazine. Two subtherapeutic dosages were evaluated in powder mixtures to gain information about their\npotential to pollute the pig barn. Furthermore, a new group of pigs was kept in the stable after powder feeding\nof another pig group to determine the possible absorption of environmentally distributed antibiotics.\nPigs were orally treated with three dosage forms. Simultaneously, sedimentation and airborne dust were collected and\nplasma and urine levels were determined.\nResults: All formulations result in comparable plasma and urine levels, but massive differences in environmental\npollution (powder > pellets, granula). Pigs housing in a contaminated barn exhibit traces of sulfadiazine in plasma\nand urine.\nConclusion: Using pharmaceutical formulations like pellets or granula, the environmental pollution of sulfonamides\ncan significantly be diminished due to massive dust reduction during feeding....
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