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Hamdy Abdelkader,Heba A. Hazzah,Magda A. EL-Massik,Ossama Y. Abdallah 한국약제학회 2013 Journal of Pharmaceutical Investigation Vol.43 No.4
Pellets are one of multiparticulate pharmaceutical forms and can offer numerous technical and biopharmaceutical advantages compared with single dose unit formulations, e.g. tablets and capsules. This study aimed at formulation of controlled-release pellets of doxazosin mesylate (DM), a widely used treatment for antihypertensive and benign prostatic hyperplasia. DM was loaded onto microcrystalline cellulose CELLETS pellets using hydroalcoholic solution and alcoholic suspension layering techniques to achieve a minimum drug load of 4 mg DM/g pellets. DM-layered CELLETS were coated by Aquacoat dispersion (ready-made ethylcellulose dispersion) using a coating pan technique as a simple and widely utilized technique in pharmaceutical industry. Controlled-release DM-layered pellets showed a release profile comparable to the controlled-release commercial product Cardura XL Tablet. Also, the mechanism of DM release from Aquacoat CELLETS was mathematically modeled and imaged by scanning electron microscopy to elucidate drug release mechanisms from the prepared pellet formulations. Accelerated stability studies of the prepared pellets were performed under stress conditions of 40 C, and 75 % RH for 3 months. In conclusion, preparation of controlledrelease DM-layered CELLETS is feasible using a simple and conventional coating pan technology.
Formulation and evaluation of taste-masked paracetamol-lipid sachets and chewable tablets
Wessam M. El-Refaie,Magda A. EL-Massik,Ossama Y. Abdallah,Nawal M. Khalafallah 한국약제학회 2014 Journal of Pharmaceutical Investigation Vol.44 No.6
The use of lipids as taste-masking excipients inparacetamol sachets and chewable tablets without compromisingdrug release was investigated. Twelve paracetamolgranule formulations were prepared by meltgranulation, using Precirol (glyceryl palmitostearate),cetyl alcohol and stearic acid, at different paracetamol-lipidratios. Based on efficient taste-masking results coupledwith minimum retardation of drug release, paracetamol-Precirol (1:1), paracetamol-cetyl alcohol (1:2) and paracetamol-stearic acid (1:2) granules were selected forpreparation of chewable tablets and sachets. Formulationswere evaluated for the effect of storage, at 40 C and 75 %RH for 6 months, on their performance. Results inferredthat paracetamol sachets, after reconstitution in 100 mlwater, showed efficient taste-masking compared to controlsachets (without lipids). The sachets released more than90 % of their drug content in 30 min, when tested in900 ml of phosphate buffered saline, pH 5.8. Chewabletablets exhibited comparable taste-masking effect to areference product, Tylenol 80 mg chewable tablets, andyielded similar drug dissolution profiles (similarity factorf2[50). Differential scanning calorimetry indicated theabsence of interaction between paracetamol and lipids. Scanning electron micrographs supported the obtainedresults. Upon storage at 40 C and 75 % RH for 6 months,all the prepared sachets and chewable tablets were found tobe stable except cetyl alcohol-based tablets that showeddecrease in the efficiency of taste masking with increase inrelease rate. In conclusion, selected lipids, Precirol, cetylalcohol and stearic acid, could be efficiently used in formulationof taste masked paracetamol sachets and chewabletablets without adversely delaying drug release.