Purpose: Gliclazide has been found to form inclusion complexes with β-cyclodextrin (β-CD) in
O ral dissolving drug delivery system offers a solution for those patients having difficulty in swallowing tablets/capsules, etc. Zingiber officinale, has been used for medicinal purpose since antiquity to treat motion sickness, pregnancy, and cancer-chemotherapy-induced vomiting, mild stomach upset, cough, chronic bronchial problems, and low-grade infections of all kinds and anorexia condition. This work investigates the possibility of developing Zingiber officinale oral dissolving films allowing fast, reproducible dissolution in oral cavity; thus bypassing first pass metabolism. The oral dissolving films were prepared by solvent-casting method. Prepared films were evaluated for film-forming properties, physico-mechanical properties, palatability, microbial limit test, accelerated stability studies, and clinical efficacy test. The different polymers such as hydroxypropyl methylcellulose 5cps, maltodextrin, pullulan, and polyvinyl alcohol were explored individually and in combination with each other for the formation of film. Among all polymers, maltodextrin and HPMC 5 cps alone and in combination showed excellent film-forming properties as well as very good physico-mechanical properties. The films resulted into excellent palatability along with least disintegrating time. But at accelerated stability studies, only HPMC 5 cps was found to be stable when compared with other formulations. So, it was concluded that HPMC 5 cps is the best film forming as well as stable polymer with respect to Zingiber officinale oral dissolving film. Optimized content for mobile and hand-held devicesHTML pages have been optimized of mobile and other hand-held devices (such as iPad, Kindle, iPod) for faster browsing speed. Click on [Mobile Full text] from Table of Contents page. This is simple HTML version for faster download on mobiles (if viewed on desktop, it will be automatically redirected to full HTML version)
The present study was undertaken to examine the effect of pH and concentration of hydroxypropyl-β-cyclodextrin on the solubility of carvedilol as it shows pH-dependent solubility. The equilibrium solubility of carvedilol in a series of solutions of varying pH (from 1.2 to 11) was determined and compared with the equilibrium solubility of carvedilol in the presence of 20% hydroxypropyl-β-cyclodextrin at same pH values. It was observed that solubility of protonated form is more than neutral molecule. Hydroxypropyl-β-cyclodextrin resulted in increased solubility at all the pH. But inclusion in the cavity of hydroxypropyl-β-cyclodextrin might depend upon charge state of the molecule. So it can be concluded that solubility of carvedilol, can be increased either by the addition of hydroxypropyl-β-cyclodextrin or by adding pH lowering agents. But both these methods if are to be used together, pH should be selected carefully.
In the present study, an attempt was made to prepare immediate-release enteric-coated pellets of aceclofenac, a poorly soluble nonsteroidal anti-inflammatory drug that has a gastrointestinal intolerance as its serious side effect. Formulation of enteric-coated pellets with improved solubility of aceclofenac could address both of these problems. To achieve these goals, pellets were prepared by extrusion-spheronization method using pelletizing agents that can contribute to the faster disintegration and thereby improve the solubility of the drug. Different disintegrants like beta-cyclodextrin, kollidon CL, Ac-Di-Sol, and sodium starch glycolate were tried in order to further improve disintegration time. The pellets were characterized for drug content, particle size distribution, flow properties, infrared spectroscopy, surface morphology, disintegration rate, and dissolution profile. The formulations, which showed best disintegration and dissolution profiles, were coated with Eudragit L100-55, an enteric-coated polymer which does not dissolve at gastric pH but dissolves at intestinal pH, releasing the drug immediately in the dissolution medium. The optimized enteric-coated formulation containing 20% kappa-carrageenan, lactose, and sodium starch glycolate as a disintegrant did inhibit the release of the drug for 2 h in 0.1 N HCl, whereas 87% of the drug was released within 45 min. The improvement was substantial when it was compared with solubility of pure drug under the same conditions. Thus, dissolution profiles suggested that combination of kappa-carrageenan and sodium starch glycolate resulted into fast-disintegrating, immediate-release pellets, overcoming the bioavailability problem of the poorly soluble drug, aceclofenac, and enteric coating of these pellets avoids the exposure of aceclofenac to ulcer-prone areas of the gastrointestinal tract.
Objective: In the present work attempt has been made to stabilize optimized nanosuspensions of glimepiride by solidification using a novel Oral Thin Film (OTF) formulation.Methods: Nanosuspensions were characterized for particle size, zeta potential as well as in vitro dissolution profile. As nanosuspensions are prone to destabilization by Ostwald's ripening or agglomeration/aggregation, OTF formulation as a novel approach for stabilization through solidification of optimized nanosuspension was attempted. OTF formulation method is a simple, easy and scalable method for the preparation of solid oral dosage form. Prepared formulations were evaluated for physicochemical parameters like folding endurance, disintegration time, tensile strength, in vitro drug release, in vivo bioavailability and stability. Results:The mean particle size of the nanoparticles in OTF was found to be 57.2 nm. It was observed from the results of in vivo bioavailability studies that high plasma drug concentrations(Cmax) were achieved for nanosuspension loaded OTF (NSOTF) i.e. 4900 ng/ml as compared to marketed oral formulation (Cmax-2900 ng/ml). Results of the stability studies indicated that nanosize of the particles was retained even after 3 mo of the study. Conclusion:Therefore it can be concluded that OTF formulation has a potential for stabilization of nanosuspensions.
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