Formulation And Characterization Of Palm Oil Esters Based Nano-Cream For Topical Delivery Of Piroxicam: Study Of In Vitro Release And In Vivo Anti-Inflammatory And Analgesic Effects

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Date
2010-06
Authors
Muthanna F. Abdulkarim
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Publisher
Universiti Sains Malaysia
Abstract
During recent years, there has been increased interest in the use of topical vehicle systems that could assist drug permeation through the skin. The drugs of interest usually those causing or having problems when given orally, e.g., easily hydrolyzed in the gastro-intestinal tract, poor bioavailability or to cause adverse reactions. One such drug is piroxicam, a highly effective anti-inflammatory, anti-pyretic and analgesic but causes gastro-intestinal ulcers and bleeding. One of the most promising vehicle systems for trans-dermal permeation of drugs is a nano-cream, a semisolid emulsion with droplet size of 20-200 nm. The main purpose of this study is to formulate a novel nano-cream I containing piroxicam for topical delivery and to use palm oil esters (POEs) a new derrivetised palm oil as the oil phase. In the initial study, pseudotemary phase diagrams of water, POEs and non-ionic surfactant mixture of several HLB values were constructed and several promising nano-cream formulae were selected. The stability under different temperatures and other properties of the formulations including the rheological behaviour, zeta potential, droplet size and structural characteristics of the formulation and Solubility and partition coeffecient of piroxicam were studied. Based en the initial studies conducted on selected several tornllllae, a fonnula with 25:37:38 basic composition of palm oii esters: aqueous phase: surfactant mixture (80% Tween 80: 20% Span 20 HLB 13. 72) was used to prepare several nano-creams using phosphate buffer pH 4, pH 6 and pH 7.4 respectively as the external phase. The abilities of these formulae to deliver piroxicam through cellulose acetate membrane and full thickness rat skin were assessed in vitro using Frantz diffusion cell. E 15 and E 16 were identified as the promising formulae and their pharmacodynamic effects were evaluated and compared with a preparation available in market. Anti- inflammatory effect was measured by using carragennan-induced hind paw edema method where the edema volume was measured in term of paw thickness. The analgesic activity was measured as the pain threshold response. In conclusion, the 0.5% nano-creams formulated by using the POEs as the oil phase and phosphate buffer pH 6 and 7.4 as external phase were found to have suitable rheological, droplet size and stability properties. Nano-cream (pH 7.4) E 16 had shown a better in vitro transfer through cellulose acetate membrane and full thickness rat skin as compared to nano-cream (pH 6) and a product available in market. This could be due to the higher flux calculated. The E 16 nano-cream (pH 7.4) showed the best anti-inflammatory and analgesic activities among the preparations tested.
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Keywords
Formulate a novel nano-cream I containing piroxicam , use palm oil esters.
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