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Divakar R. Jaiswar,Purnima D. Amin,Durgesh Jha 한국약제학회 2016 Journal of Pharmaceutical Investigation Vol.46 No.7
In the present study aim was to prepare stable solid solution azithromycin dihydrate (AZI) by hot melt extrusion technology (HME). Soluplus and Kollidon VA 64 were selected among polymers based on Hansen solubility parameter calculation in order to prepare amorphous of AZI. Further physicochemical properties of extrudates were characterized by DSC, FTIR, XRD, SEM and contact angle measurement. DSC revealed single broad endothermic peak in extrudates indicated miscibility of AZI into polymeric carriers, which formed monophasic solid system termed as solid solution. XRD confirmed amorphous nature of AZI in extrudates. DSC and XRD suggested molecular dispersion of AZI in polymeric carriers. Amorphous AZI exhibited statistically significant high solubility (P\0.0001) in water in comparison with pure AZI. Solid solution batch AZI 03 showed significant enhancement in solubility (P = 0.0004) in pH 6. The dissolution in dissolution medium pH 6 and water resulted in statistically significant differences (P\0.05) in the percentage amorphous AZI dissolved compared to the percentage AZI dissolved over the period of 60 min. Solid solution formulation showed better wettability than that of pure AZI. Amorphization and increased wettability attributed to solubility and dissolution rate enhancement. Assay and amorphous solid solution characteristics of AZI were found to be stable under accelerated storage condition as per ICH guideline for a period of six months. Therefore, hot melt extrusion technology was suitable method to prepare stable solid solution and dissolution rate enhancement for poorly soluble active like AZI.
Avinash B. Gangurde,Ritesh A. Fule,Sharadchandra D. Javeer,Rahul K. Patole,Jaywant N. Pawar,Purnima D. Amin 한국약제학회 2015 Journal of Pharmaceutical Investigation Vol.45 No.2
Choline bitartrate (CBT) is a water solubleessential nutrient belongs to vitamin-B family. It is moisturesensitive in nature and marketed formulation has stabilityrelated problems during storage which curtails itseffectiveness. Waxes such as hydrogenated soya bean oil(HSO) reported to be an excellent coating carrier to reducemoisture sensitivity or hygroscopic nature of drug candidates. However, literature dictates HSO applications hasbeen explored mostly using non-aqueous methods or hotmelt techniques of formulation development. In this work,microparticles of choline bitartrate with aqueous coatingdispersion of HSO as primary carrier was successfullydeveloped using fluidized bed coating technique. Aqueousdispersion of HSO was prepared using selected binder in ahomogenizer and formed aqueous dispersion was thensprayed through 0.8 mm gun in fluidized bed processor. The microparticles were evaluated for parameters like flowproperties, morphological characteristics, drug content,encapsulation efficiency and drug release behaviour. Thesolid state characterization of optimized microparticlebased formulation was done by differential scanning calorimetry,X-ray diffractometry, infrared spectroscopy andscanning electron microscopy. The results showed thatmicroencapsulation of choline bitartrate were successfullydone by aqueous wax coating dispersion without using anyorganic solvent or hot melt techniques. Discolouration,fishy odour and drug content variation was not observedafter 6 months stability studies. Choice of proper carrier todrug ratio and selective formulation technique are criticalparameters for dispensing CBT microparticle based formulationwhich might significantly enhance itseffectiveness.
Preparation and evaluation of carbamazepine loaded fibrous electrospun mats of starch
Tarique Ali Meer,Mirza Shehzad Baig,Purnima D. Amin 한국약제학회 2015 Journal of Pharmaceutical Investigation Vol.45 No.3
The preset work deals with preparation of fibrous electrospun mats of starch (FEMOS) carrier, from naı¨ve starch, through a process of electrospinning. The developed FEMOS was explored for the solubility enhancement of poorly water soluble drug carbamazepine. Solid state characterization was performed with respect to Fourier transform infra-red spectroscopy, X-ray diffraction, scanning electron microscopy, contact angle determination, dissolution kinetics, and differential scanning calorimetry. Rapid release profiles were observed when the carbamazepine was loaded on FEMOS. This effect may be due to high surface area, improved wettability and reduced crystallinity of the loaded drug on FEMOS. The developed formulation was found to have a similar in vivo performance as compared to marketed formulation TegretolⓇ.