Abstract
FORMULATION DEVELOPMENT AND EVALUATION OF MICROPARTICLES OF PARACETAMOL USING NATURAL POLYMER

Dinesh P. Patil*, Dr. S.R. Tambe, Dr. J.V. Musale, Mahfoozur Rahman, P.P. Nahar and S.D. Pawar

ABSTRACT

The present work focused on the formulation and Development of microparticles of paracetamol using natural polymers. Microprticels was prepared using different concentration of natural polymers like prosopis seed gum and gaur gum. ionotropic gelation method was used to prepare the paracetamol microparticels. one of the important method of separation and purification of Prosopis seed gum (mucilage) was use and easy Prepare of paracetamol loaded microparticles Prosopis seed gum was showed superior sustained release properties when compared to the guar gum. The formulations F1-F4 (using prosopis seed gum) showed more sustained release effect as compared to formulations F5-F8 (using guar gum). Methods: Microparticles prepared by ionotropic gelation method. Materials used in this study were obtained from the different sources. Paracetamol was purchased from Research-lab fine chem industries.(Mumbai, India). Guar gum was purchased from Balaji drug. (Ahmedabad, India). Sodium alginate was purchased from Vishal-chem. (Mumbai, India). Prosopis seeds were collected from fields of Malegaon and Isolation of polymer was carried out in laboretories of K.B.H.S.S Trust’s Institute of Pharmacy, Malegaon, District- Nashik, India. All other chemicals and reagents used were either analytical or pharmaceutical grades. 1. Authentication of plant The collected plant was authenticated by Botanical survey of India, Western Regional Centre, Pune, Maharashtra, Wide voucher number BSI/WRC/TECH/2011/ABGPROJ3 2. Separation and purification of Prosopis seed gum (mucilage) Seeds were separated from the plant Prosopis juliflora. Then seeds were immersed in 100 ml of hot water at 80–900C for 1 h and allowed to soaked for 12 hours. During this period the seeds swelled. After that seeds were removed from water and gum (i.e. endosperm) was separated manually from these swollen seeds. Separated gum was added to 100 ml distilled water and stirred for 6 hrs to form uniform slurry after this, slurry was added to equal volume of acetone. This leads to precipitation of pure gum then dried in oven at temperature less than 500c. 3. Preparation of paracetamol loaded microparticles The weighed amount of sodium alginate was dissolved in 50 ml water. After that weighed amount of prosopis seed gum was added to above solution and heated to 60˚C with stirring by mechanical stirrer for 1hr to form uniform slurry. After cooling, weighed amount of Paracetamol was dispersed in to polymeric solution and stirred for 30 min. After complete mixing, this solution was added drop wise from the distance 2.5 cm using syringe fitted with needle (23G) into 50 ml calcium chloride solution (5%) as cross linking agent. Microparticles were left for curing for specified time (15 min) and after curing; microparticles were collected by filtration and allowed to dry at room temperature for 24 hrs. Four batches (F1-F4) of microparticles were prepared by varying concentration of prosopis seed gum (1.5-3%). Same procedure was followed for preparation of microparticles using guar gum (F5-F8).[8] The dried microparticles were weighed and stored for further evaluations. Prepared Paracetamol microparticles were evaluated for size, sphericity, % yield, % entrapment efficiency, % swelling index and % drug release for 8 hrs. 4. In vitro Dissolution studies In vitro dissolution studies were performed for all the formulation using USP dissolution test apparatus I (basket type). An accurately weighed sample of microparticles containing equivalent paracetamol drug (500 mg) were placed in basket. A muslin cloth was tied over the basket to prevent the slippage of microparticles from the basket. The dissolution study performed using 900ml of 0.1N HCl for 2 hrs. after 2hrs 0.1N HCl was replaced by 900 ml of 6.8 pH phosphate buffer solution and maintained at a temperature of 37ºC ± 0.5ºC and the rotation of basket at a speed of 100 rpm. 5ml aliquots of the samples were withdrawn at half hr interval and the volumes were replaced with an equivalent amount of plain dissolution medium kept at 37ºC. The collected samples were diluted to suitable concentration with dissolution medium analyzed at λmax 243 nm using a LABINDIA 3000+ UV-visible double beam spectrophotometer against blank. The dissolution study performed in replicates and results expressed were the mean of six experiments.[15] Conclusion: Prosopis seed gum showed better sustained release effect than guar gum and it was evident that promising sustained release microparticles of paracetamol may be prepared by ionotropic gelation method using Prosopis seed gum with small concentration of sodium alginate.

Keywords: Paracetamol, Prosopis seed gum, Guar gum, Ionotropic gelation method.


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