Current Issue : July - September Volume : 2013 Issue Number : 3 Articles : 9 Articles
In the current study, triple layer matrix tablets were formulated by using HPMC K100, K15, E 50, and Eudragit L 100 as barrier layers. The main motto of the study is to increase the mean dissolution time and decrease the dissolution efficiency. Triple layer tablets have been focused to promote zero order release unlike mono layer tablets. As mono layer tablets experience prolonged drug release with initial burst release, Triple layer matrix tablets have come into existence to overcome the burst release problems of conventional tablets. FTIR studies revealed that there is no interaction between the excipients and drug used in this triple layer tablet formulations. The triple layer tablets were evaluated by physiochemical parameters like thickness, hardness, friability and disintegration time. Differences in dissolution characteristics of formulations F1 to F5 were observed. The two barrier layers present at up and bottom of tablet will restrict the release of drug from the tablet allowing prolonged and slow release of drug. Eventually, atenolol triple layer tablets can be suitable for sustained release of drug over prolong period of time....
Ionizable but water insoluble or poorly soluble drug like Rosuvastatin Calcium shows poor bioavailability. Self (Micro) Emulsifying Drug Delivery System can improve bioavailability of drug. Aim of this research work is to develop self –micro emulsifying drug delivery system (SMEDDS) of Rosuvastatin Calcium. Capmul-PG8, Acconon-MC8, Tween-80 and Propylene glycol were used for development of formulation with highest efficiency. Ternary graph revealed that minimum of 65% of surfactant is required to get best desirable results. Optimized formulation shown average globule diameter of 162 nm, measured by Malvern Zetasizer. Ex-vivo study as a surrogate of in-vivo study was performed by non-everted chick ileum sac absorption model. Self-emulsifying formulation shows 30% drug diffusion/cm2 area of ileum as compare to 6% of powdered drug....
Fast dissolving tablets are designed to dissolve or disintegrate rapidly in the saliva generally in less than 60 seconds. Prepared tablets were evaluated for their physicochemical properties. Powder blend were evaluated for various parameters like angle of repose, bulk density, tapped density, compressibility index, Hausner’s ratio. Directly compressed tablets were analyzed for the uniformity of drug content, thickness, hardness, weight variation, friability and in-vitro dissolution study. F6 formulation showed maximum drug release of 99.087%. The release of F8, F7, F4 was 95.986%, 97.484%, 93.867% respectively and for marketed preparation, it was 80.497%. The stability studies of the optimized formulation F6 tablets revealed that there was no significant change in the physical parameters when stored at temperature and humidity conditions of 45±2°C/75±5 % RH and at room temperature....
Mouth dissolving tablets (MDT) have the unique property of rapid disintegrating and releasing drug as soon as they come in contact with saliva obviating the requirement of water during administration. The purpose of present investigation work deals with enhancing the solubility of Felodipine, an anti-hypertensive drug and formulating into mouth dissolving tablets. The employed solubility enhancement techniques are solid dispersions and complexation. The polymers used are Beta–cyclodextrins (β-CD), Micro crystalline cellulose (MCC), and Hydroxypropylmethylcellulose (HPMC). Drug and polymer interactions were investigated by using FT-IR and DSC. The prepared Felodipine complexes and solid dispersions were evaluated for bulk density, angle of repose, percentage compressibility and drug content and were formulated into tablets. The prepared tablets were evaluated for hardness, friability, in-vitro dissolution time, wetting time and in-vitro drug release. Among the designed formulations, F4 containing 1:6 ratio of Felodipine and β–CD emerged as best formulation over all due to better disintegration and drug release....
Pellets as a multiparticulate system gain much attraction in various drug delivery system approaches. In case of sustained release or controlled release formulations, pellets give promising results weather in capsule form or as pelltab (pellets compressed into tablet). For this study purpose, pellets were prepared by extrusion-spheronization technique and estimated by UV spectrophotometer (in bulk and in formulations). Different batches were formulated by applying 22 full factorial design using guar gum as release controlling polymer. Batch G3 and G4 possessed good ability to release drug completely from the formulation within 12 hrs. Other parameters were found with good acceptability. From the result of the present study, its clear that guar gum can be used as drug release controlling polymer to formulate extended release or sustained release or controlled release formulations as it found to be significant factor to control the drug release from pellets....
The aim of this study was to increase the solubility and dissolution rate of Ebastine, a poorly water soluble anti-histaminic drug. Ebastine form an inclusion complex with HP-β-Cyclodextrin. The solubility of Ebastine with HP-β-Cylodextrin in aqueous solution was determined. The apparent stability constant was calculated from the Bs solubility diagram and found to be 5.69 M-1. The solid complexes of Ebastine with Hydroxypropyl-β-Cyclodextrin were prepared by physical method, solvent evaporation and neutralization method in 1:1 and 1:2 molar ratios. In order to confirm solid complex formation, DSC and X-RD studies were used. The dissolution rate of Ebastine in 1:2 molar ratios in pH 1.2 from the inclusion complexes was much more than the Ebastine alone....
Risk management is nothing but the identification, assessment, and prioritization of risks. Risks may be associated with uncertainty in financial markets, project failures, legal liabilities, credit risk, accidents, natural causes and disasters as well as deliberate attacks from an adversary. The strategies to manage risk includes transferring the risk to another party, avoiding the risk, reducing the negative effect of the risk and accepting some or all of the consequences of a particular risk. Various aspects of risk management standards have come under denigration for having no measurable or remarkable perfection on risk even though the confidence in estimates and decisions increase. The ICH-Q9 guideline with reference to Quality Risk Management in the pharmaceutical field (active substances and medicinal products) was adopted by the European Union and PIC/S in Annex. 20 of the EU and PIC/S GMP Guides. It is regularly being applied by drug manufacturers in particular as regards sections 1.5 and 1.6 of part I of the aforesaid....
The objective of this study was to formulate and evaluate the drug-polymer interaction of Abacavir sulphate using two polymers with different characteristics as Cellulose acetate phthalate or Ethyl cellulose. Microspheres were prepared by the emulsion solvent evaporation. The effect of drug-polymer interaction was studied for each of microspheres. Important parameters in the evaluation of a microencapsulation technique are encapsulation efficiency, yield production, particle size, surface characteristics of microspheres, scanning electronic microscopy (SEM), powder X-ray diffraction analysis (XRD) and differential scanning calorimetry (DSC). The in-vitro release studies are performed in buffer (pH 7.4). Microspheres containing cellulose acetate phthalate and Ethyl cellulose showed 82-89% and 77-86% of entrapment efficiency, respectively. The thermogram X-ray and DSC showed stable character of Abacavir sulphate in the microspheres and revealed an absence of drug polymer interaction. The prepared microspheres were spherical in shape and had a size range of 407-410 μm for Cellulose acetate phthalate microspheres and 407- 417 μm for Ethyl cellulose microspheres. The results suggest that Abacavir sulfate was successfully and efficiently encapsulated; the release rates of matrix microspheres are related to the type of polymer, only when formulation (FAEC3) used to get prolonged drug release with increasing the polymers content in the microspheres. Data obtained from in-vitro release for microspheres were fitted to various kinetic models and the high correlation was obtained in the First order model....
The purpose of this research was to mask the intensely bitter taste of Racecadotril and to formulate oral-disintegrating tablet (ODT) of the taste-masked drug. Taste masking was done by complexing Racecadotril with aminoalkyl methacrylate copolymer (Eudragit E - 100) using solvent deposition method and acetone as a solvent for pH-sensitive polymer and was tested for drug content and in vitro taste in simulated salivary fluid (SSF) of pH 6.8. The complex with drug-polymer ratio of 1: 0.5 that did not release drug in SSF was considered taste-masked and selected for formulation of ODTs. The properties of tablets such as tensile strength, wetting time, water absorption ratio, in vitro disintegration time, and disintegration in the oral cavity were investigated to elucidate the wetting and disintegration characteristics of tablets. Tablets of batch F4 containing Croscarmellose sodium and Crospovidone in ratio 8:4 showed faster disintegration, within 8 seconds. Good correlation between in vitro disintegration behavior and in oral cavity was recognized. Taste evaluation of ODT in human volunteers revealed considerable taste masking. Racecadotril ODT also revealed rapid drug release in acetate buffer pH 4.5 with 1% SLS. Thus, results conclusively demonstrated successful masking of taste and rapid disintegration of the formulated tablets in the oral cavity....
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