Diclofenac Sodium

A simple and precise stability-indicating high performance liquid chromatography method was developed and validated for the simultaneous estimation of Tolperisone Hydrochloride and Diclofenac Sodium in commercial tablet dosage form. Separation was achieved by using C18 (250mm × 4.6 mm, 5µm) column and mobile phase comprising of potassium dihydrogen phosphate buffer (pH: 6.0): acetonitrile (70:30% v/v) at a flow rate of 1.0ml/min. The detection wavelength was 275 nm. The retention times for Tolperisone Hydrochloride and Diclofenac Sodium were 5.26min and 3.59min, respectively. Linearity of Tolperisone Hydrochloride and Diclofenac Sodium were found in range of 15-52.5µg/ml and 5-17.5µg/ml. The % recovery of Tolperisone Hydrochloride was found to be 99.58%-100.88% and 100.75%-101.33% for Diclofenac Sodium. The values of Limit of detection and limit of quantification were found to be 0.203µg/ml and 0.616µg/ml for Tolperisone Hydrochloride and 0.003µg/ml and 0.010µg/ml for Diclofenac Sodium, respectively. The linear regression coefficient for both drugs was found to be 0.999. The method was found to be robust since the retention times and areas were within the limits even after little deliberate variations in pH, flow rate, mobile phase ratio. Stress studies were conducted on the drug substance and product under the ICH prescribed stress condition viz. hydrolysis, oxidation, photolysis and thermal stress. The drugs showed sufficient decomposition under acidic hydrolysis, alkaline hydrolysis, and oxidation. The drug was found to be moderately sensitive to thermal studies and sunlight studies. This method can be successfully employed for simultaneous quantitative analysis of Tolperisone Hydrochloride and Diclofenac Sodium in pharmaceutical dosage form.

The present study investigates the anti-inflammatory activity in ethanolic extract of Canthium Parviflorum using carrageenan induced paw edema in albino rats. The medicinal values of the Canthium Parviflorum have been mentioned ancient literature as useful in disorders of inflammation. Dried leaves of Canthium Parviflorum powdered and extracted with ethanol using soxhlet apparatus. The anti-inflammatory activity was done by carrageenan induced hind paw edema method using plethys mometer. Diclofenac is used as a standard drug. The significant inhibitory activity shown by the leaf extract of Canthium Parviflorum (125, 250, and 375 mg/kg) over a period of 4h in carragenan-induced inflammation was quite similar to that exhibited by the group treated with diclofenac sodium. The highest percentage inhibition activity was found in the dose of 375 mg/kg with the mean percentage inhibition of 23.45% after 4 hours of extract administration.

Microsponges are tiny, uniform, micro-porous polymeric beads and spherical in shape. It has the interconnected voids. The particle size of it ranges between 5-300μm. The porous surface of non-collapsible structure of microsponges helps to deliver the active ingredient in controlled manner. Diclofenac Sodium is a Non-steroidal anti-inflammatory drug. The plasma half-life of Diclofenac is 1-2 hrs which increases the dosing frequency and this drug also causes the gastrointestinal irritation. Therefore the purpose of present investigation was to design suitable controlled release Diclofenac Sodium microsponges which can reduce the dosing frequency and gastric irritation. In the present work, Diclofenac Sodium loaded eudragit microsponges were prepared using quasi emulsion solvent diffusion method. Different drug: polymer ratios were used to formulate the microsponges. The compatibility of the drug with polymer was established. Surface morphology of the microsponges was examined using scanning electron microscopy. Production yield, loading efficiency, particle size analysis, and in-vitro release studies were carried out. In-vitro release study showed that the release of drug was in controlled manner and it was increased with increase in drug to polymer ratio up to certain limit.

In order to achieve rapid action and sustained release, we have fabricated dual type of mini-tablets of Diclofenac Sodium enclosed in a single capsule. 10 formulations of rapid release (IF1-10) mini tablets were prepared using sodium starch glycolate, Cross povidone and Micro crystalline cellulose. 12 formulations of sustained release (SF1-12) mini tablets were prepared by using HPMC, carbopol, Ethyl cellulose, xanthan gum and guar gum. All formulations were evaluated for pre-compression and post-compression parameters. Drug Excipient interaction was determined by FTIR, Short term stability studies were carried out at 40 0C /75 % RH for 3 months. Pre-formulation and studies conformed that all formulations showed better flow property. In vitro studies showed that all mini tablets in combination released more than 55 % within 30 min whereas marketed tablet Voveran SR 100 showed only 11 % release indicating the rapid drug release and the release was extended up to 80 % in 20th hour indicating the sustainability of the release. Natural polymers, Xanthan gum and guar gum containing formulations showed above 90 % in 12th hour indicating little rapid drug release when compared to synthetic polymers. FTIR report indicated no interaction of drug with excipients. Stability studies showed no significant loss in drug content, release profile and physical appearance. Hence it can be concluded that, the release profiles duel type mini tablets were quite promising for once a day formulation.

  Transdermal films of Diclofenac Sodium were formulated by using Hyptis suaveolens seeds mucilage as film forming agent in various concentration. According to the research articles and mucilage can be used as film forming agent. Hyptis suaveolens seeds mucilage is naturally occurring polymer containing polysaccharide which cannot be used as film forming agent before. There are tremendous researches on natural polymers in today’s world because of various advantages of natural polymer over synthetic. Therefore we can take it for further examination as film forming agent and its evaluation. Drug polymer interactions determine by using FTIR and DSC. The medicated films were evaluated for physicochemical properties and also medicated films were evaluated for area variation, drug content and percent cumulative drug release. In vitro drug release study through cellophane membrane indicates that hydrophilic polymer showed higher release. The release rate found to follow first order rate kinetic. The prepared patches will evaluated for thickness, folding endurance, tensile strength, drug contain uniformity, in-vitro permeation study. In vitro drug release study was performed by using artificial membrane.