• Formulation and Characterization of Oral Suspension Containing Ibuprofen

      The present work was aimed with the objective of formulating oral suspension of ibuprofen to enhance the convenience and compliance by the elderly and pediatric patients. The suspension were prepared by incorporating the prepared ibuprofen physical mixtures so as to achieve the aimed percent drug release (using poloxomer, Poly vinyl pyrrolidone (PVP and PolyVinaylAlcohol (PVA)) in sodium carboxy methyl cellulose as dispersing medium. Particular attention was given to the selection of the suitable taste masking agents. The suspension was characterized in term of ibuprofen content, viscosity, and sedimentation volume and dissolution test. The promising suspension F8 having the optimal formula showing the greatest dissolution and satisfactory sedimentation volume and physico-mechanical properties compared with a reference marketed product. FT-IR studies revealed that there is no interaction between the drug and the polymers used in the study. Rheological studies revealed significant difference between the suspensions that the incorporation of PVP and PVA enhances the viscosity of the suspension as a result the rate of dissolution was retarded. Download
    • Formulation, Development and Characterization of Chronotherapeutic Time Released Press Coated Nizatidine Tablets

      The aim of present study was to develop and characterize pulsatile release tablets of Nizatidine, H2 antagonist, for effective treatment of Peptic ulcer. The pulsatile tablets prepared by compression coating method consisted of two different parts: a core tablet, containing the active ingredient and an erodible outer coating layer of polymer. The rapid release core tablets were prepared by using superdisintegrant along with active ingredient. Compression coating of optimized core tablets was done by using HPMC K100M and Ethyl Cellulose. The effect of formulation composition on the barrier layer comprising both polymers, excipients on the lag time of drug release was investigated. The Core tablets and press coated tablets were evaluated for weight variation test, thickness, hardness, friability, Disintegration, lag time and dissolution study. An increase in lag time was observed with the increasing concentration in each case. Formulation F4 containing HPMC K100M and Ethyl Cellulose was found to provide desired lag time, drug release profile, better integrity among all formulations and thus, compliant with the chronotherapeutic objective of Peptic Ulcer. Download
    • Formulation and Evaluation of Curcumin Loaded Gastro-Retentive Multi particulate Drug Delivery System

      To develop and optimize a multiparticulate gastro-retentive floating dosage form of Curcumin with targeted and sustained release characteristics. Curcumin give protective effect against Inflammation and Cancer but the physicochemical properties of the molecules leads to poor solubility and stability. Aqueous solubility was enhanced by complex formation with Hydroxypropyl β-Cyclodextrin (HP β-CD). This complex with enhanced solubility profile was further used to prepare multiparticulate floating pellets. Floating pellets of Curcumin HP β-CD complex were prepared by Extrusion-Spheronization technique using Hydroxypropyl methylcellulose (HPMC K100 M) as low density controlled release polymer, Ethyl cellulose as a release retardant polymer and Sodium bicarbonate as a gas generating agent. The formulations were evaluated for In vitro Drug release, Buoyancy and Surface morphology study. The investigation revealed that floating pellets of Batch B3 possessed optimum formulation characteristics. The drug release from pellets was Non fickian and sufficiently sustained for 12 hr. This study indicates that multiparticulate gastro-retentive floating dosage form of Curcumin HP β-CD complex with sustained release characteristics can be safely and effectively used to treat Gastric cancer. Download
    • Forced Degradation Study for Assay Method of Rifampicin, Isoniazid and Pyrazinamide in Combined Pharmaceutical Dosage Form

      As HPLC method is time consuming, very accurate and precise method was developed for simultaneous estimation of Rifampicin, Isoniazid and Pyrazinamide from Rifampicin, Isoniazid, Pyrazinamide and Ethambutol dosage form by UPLC. Forced degradation study was performed on this method to establish the method is stability indicating. The liquid forced degradation and solid degradation study was carried out on Acquity UPLC @BEH C18, (100 mm x 2.1 mm), 1.7 µm column using the gradient composition of mixture of phosphate buffer pH 6.8 and acetonitrile in ratio of 96:4 v/v as mobile phase A and mixture of phosphate buffer pH 6.8 and acetonitrile in ratio of 45:55 v/v used as mobile phase B at flow rate 0.25 mL/min and detection wavelength 238 nm. Download
    • Formulation and Evaluation of Multi-particulate Drug Delivery System of Pepsin Enzyme

      The aim is to develop multi-particulate drug delivery system for pepsin. Multi-particulate systems offer advantage with respect to predictable and even distribution and transportation through GI track. Multi-particulate system can be prepared by various techniques such as agitation, Powder layering, solution layering. In this study, multi-particulate systems of pepsin have been attempted using Lactose and Guar gum as principal excipients. Suitable dough of pepsin with excipients was prepared and pass through sieve # 8.The extrudets were spheronised using spheronizer. Factorial design was applied using speed (RPM) and time for spheronisation as independent variables at three levels. Formulations were evaluated for particle size, % yield, % entrapment efficiency, Disintegration time and In vitro drug release. Relationship between dependent and independent variables was established using design expert 7.0.0. Download
    • Formulation Development and in vitro Evaluation of Sustained Release Tablets of Telmisartan by Solid Dispersion Technology

      In the present work ,an attempt was made to formulate sustained release tablets of Telmisartan by solid dispersion technique for improving solubility Telmisartan using PEG 4000 and PVP K30.The Telmisartan tablets were prepared by wet granulation method using HPMC K4M as sustained release polymer in different concentrations .The prepared tablets were evaluated for various physiochemical parameters, In vitro Drug release study was carried out in phosphate Buffer PH 6.8using USP TYPE II paddle apparatus. Increase in HPMC concentrations resulted in a significant decrease in Telmisartan release .tablets containing 75 mg of HPMC K4M (f1and f4) shows 78% and 70% drug release upto 9 hr. Tablet containing 90 mg of HPMC K4M (f2and f5) shows 80 % and 81%drug release upto 9 hr. and tablet containing 105 mg HPMC K 4M (f3 and f6)shows highest drug release 91%and83% compared to other formulations. the in vitro data is fitted in to different kinetic models like zero order ,first order, korsmeyer and matrix plot. From this study, it was clarified that solid dispersion technique was one of the promising sustained release system applying for the poorly water soluble drugs. Download
    • Formulation, Development and Evaluation of Fast Dissolving Film of an Antihypertensive Drug

      Hypertension is a major cause of concern not just in the elderly but also in the youngsters. An effort was made to formulate a fast dissolving film(FDF) containing Indipamide which is used in the treatment of hypertension with a view to improve the onset of action, therapeutic efficacy, patient compliance and convenience. The major challenge in formulation of oral films of Indipamide is that it shows very less solubility in the pH range of 3–9. Various film forming agents and polyhydric alcohols were evaluated for optimizing composition of fast dissolving films. Fast dissolving films were formulated using solvent casting method. Optimized formulations were evaluated for their weight, thickness, folding endurance, appearance, tensile strength, and disintegration time and dissolution profile. Download
    • Formulation, Development and Evaluation of Orodispersible Tablets of Lansoprazole

      The purpose of the present research work was to prepare & evaluate the ODT of Lansoprazole using Indion-414 & Indion-234 by Direct Compression method. Lansoprazole is a proton pump inhibitor (PPI) which is used in the management of acid-related disorders. Primarily powder blend (Drug & Excipients) was evaluated for precompression parameters and further tablet was compressed by direct compression method. Then the formulations were evaluated for weight variation, disintegration time, hardness, friability, drug content, water absorption ratio, wetting time, in vitro disintegration and in vitro dissolution. All the formulations showed low weight variation & from that F5 batch of Lansoprazole containing Indion- 234 (3% w/w) have less DT (12 sec), wetting time 18 sec % Drug release in 60 sec is 83% as compared to Indion-414 Dt Time was 17 sec. This work help in understanding the effect of formulation processing variables especially the resin which is used as a tablet disintegrant & the cost of resin is less as compared to conventional superdisintegrants. Also it gives rapid absorption, improved bioavailability, effective therapy and patient compliance. Download
    • Formulation and Evaluation of Herbal Gel Containing Psidium Guajava Linn Leaves Extract

      Objective- In the present study an attempt was made to formulate gel containing Psidium guajava linn extracts and was evaluated for antimicrobial activity against different microorganism. Method- The plant were collected and extracted with suitable solvent. Different gels were formulated by using different concentration of extracts. The evaluation was done using Agar well diffusion method. The gel formulation was designed by using Carbopol 940, Psidium guajava linn extract, Propylene glycol 400, Methyl paraben, Propyl paraben and required amount of distilled water. Then skin pH (6.8-7) was maintained by drop wise addition of tri-ethanolamine. Result- The physiochemical parameters of formulations (pH, viscosity, spreadability etc.) were determined. The herbal gel showed that formulation containing Psidium guajava linn extract have better Antimicrobial activity. Conclusion- Our literature survey revealed that the herbal gel of leaves extract from leaves of Psidium guajava linn was not investigated in the present study. Download
    • Formulation and Evaluation of Film Coated Tablet of Rosuvastatin

      Rosuvastatin is an antilipidemic agent that competitively inhibits hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase. Hypo-lipidemic is a disorder of cholesterol level in a liver. Thus formulating Rosuvastatin into a flim coated dosage form would provide fast relief. The tablets were evaluated for the drug content, weight variation, water absorption ratio, wetting time, in vitro disintegration, hardness, friability, thickness uniformity. The tablets disintegrated in vitro within 37 to 40 seconds complete drug were released from tablet within 30 minutes. The results showed that Rosuvastatin Calcium was successfully formulated into a flim coated dosage form. Download
    • Formulation and Evaluation of BuccalFilms of Ranitidine Hydrochloride

      Buccal drug delivery system is been considered as a potential non invasive route of drug administration with several advantages viz prolonged therapeutic effect dose reduction improved bioavailability lesser side effects than conventional dosage forms etc. The present investigation involves formulation evaluation and comparison of formulated polymeric buccal patches using ranitidine HCL as model drug the formulations were prepared by solvent evaporation / casting method. The prepared buccal patches were evaluated for thickness, drug content uniformity, weight variation, folding endurance, swelling index, surface pH, surface morphology, in-vitro & ex-vitro drug release.In-vitro release studies were performed across cellophane membrane using Franz Diffusion Cell (FDC). The surface morphology of the patch was examined by Scanning Electron microscopy (SEM). Based on the physicochemical and in-vitro release study, formulation F3, F4 and F5 were chosen for further ex-vivo release studied. Ex- vivo permeation studied were carried out through buccal mucosa of pig using FDC. Drug release data were fitted to various pharmacokinetic model equations such as zero order kinetics, first order kinetics, Higuchi’s and korsmeyerPeppas model in order to find out mechanism of drug release. Download
    • Formulation and Evaluation of Orally Fast Dispersing Tablets of Terbutaline Sulphate

      The present research work was undertaken to develop mouth dissolving tablet of terbutaline sulphate with benefits to the patients. Superdisintegrants such as Crospovidone, Crosscarmellose and Sodium Starch Glycolate were used. A combination of two different diluents in various concentrations was used along with superdisintegrants. The tablets were prepared by direct compression method. The tablets were evaluated for hardness, friability, weight variation, wetting time, disintegration time and the selected formulation was compared with in vitro dissolution test. It was concluded that a mixture of diluents improves disintegrate rapidly and provide rapid onset of action as compare with conventional formulation. Download
    • Formulation Strategies to Overcome Multidrug Resistance in Cancer

      Cancer is the uncontrolled and abnormal cell death that affects millions of people. Various cytotoxic agents are used to treat cancer like taxanes and anthracyclines, but the toxicity and drug resistance against the cancerous cell will produce troublesome which hinders chemotherapy efficacy. Drug resistance is basically associated with increased expression of MDR1 gene that encodes for drug efflux pump known as P-glycoprotein which leads to Multidrug resistance; so to overcome the MDR , various therapeutic agents in combination have become the primary strategy to treat drug resistant cancer, but these combination regimens will lack uniform pharmacokinetic profile results in inconsistent drug uptake leads to poor and erratic bioavailability. Various nanoformulation strategies such as dendrimers, liposomes, Vitamin E based nanomedicines, polymeric nanoparticles, micelles and drug polymer conjugates are emerged as an effective drug delivery system for treatment of drug resistant cancer cells which overcome MDR and improves chemotherapy efficacy. Current review highlighting various formulation strategies to overcome MDR by inhibiting ATP dependent membrane efflux pumps through various mechanisms. Download
    • Formulation And Evaluation of Gastroretentive Floating Matrix Tablets of Metronidazole Using Khaya Ivorensis Gum

      This study was carried out to design and evaluate gastro-retentive floating matrix tablets (GFMTs) of metronidazole formulated using Khaya ivorensis gum. Granules were prepared by wet granulation technique using the gum at varying concentrations (2, 4, 6 and 8% w/w). Sodium bicarbonate (30%) and tartaric acid (5%) were incorporated as the gas generating agent. Formulations were either prepared alone with the Khaya ivorensis or with the addition of 1.0% w/w of acrylatemethacrylate copolymer. All granules were evaluated for micromeritic properties and compressed at an optimized compression pressure of 30 arbitrary units on the tableting machine load scale. Tablets were evaluated for hardness, friability, floating lag time, in vitro buoyancy test and drug release profiles. Release data were subjected to analysis by zero order flux, first order, Higuchi square root of time relationship and Korsmeyer equations. Results revealed that all formulated gastroretentive floating matrix granules (GFMG) were free flowing with angle of repose and Carr’s index ≤ 29.1o and ≤ 19% respectively. The floating lag time for GFMTs was ≤ 725 seconds. The in vitro buoyancy test of GFMTs formulations using the gum alone (i.e. without the incorporation of acrylatemethacrylate copolymer) were <12 h while those with acrylatemethacrylate copolymer were >12 h. All GFMG were compressible with tablet hardness between 14.1 – 45.7N while percentage friability was ≤ 0.97%. There was a significant difference in tablet hardness with increase in binder concentration (p<0.05). All formulations fitted well into Higuchi model release kinetics. Formulations KI - K3 have their exponent values <0.45, hence their release mechanism was by Fickian diffusion while for K4 and K5 their exponent values > 0.45, therefore the release mechanism for all these formulations was by non Fickian diffusion. The conclusion is that GFMTs of metronidazole have been developed using Khaya ivorensis gum which can sustain drug formulation for up to 10h. Download
    • Formulation and Evaluation of Transdermal Patches of Antihypertensive Drug

      Transdermal therapeutic system are defined as self-contained, discrete dosage forms, which when applied to the intact skin, deliver the drug(s), through the skin, at a controlled rate to the systemic circulation so that it can improve the therapeutic efficacy and safety of the drugs. Through a diffusion process the drug enters the bloodstream, directly through the skin. The main disadvantages to transdermal delivery systems stems from the fact that the skin is a very effective barrier, as a result only medications whose molecules are small enough to penetrate the skin can be delivered. The purpose of this study was to develop suitable matrix transdermal therapeutics system of atenolol with different proportions of Ethyl cellulose (EC) and Hydroxy Propyl Methyl cellulose (HPMC). Five formulations were prepared by solvent casting method. The prepared patched showed satisfactory physiochemical characteristics of weight uniformity, thickness, folding endurance, moisture lost, moisture absorption for stability of the formulation and drug content were uniform in all patches. Invitro study done by using Franz diffusion cell having cellophane membrane to determine the amount of drug present in the formulation patch. In different formulation on the basis of evaluation parameters and by optimization study formulation F4 shows satisfactory drug release pattern. Download
    • Formulation and Evaluation of Cefpodoxime Proxetil Solid Dispersion: An Approach for Dissolution Enhancement of Cephalosporin

      Cefpodoxime Proxetil is an broad spectrum, third generation cephalosporin drug used in the treatment of skin infections, upper respiratory tract and urinary tract infections. Furthermore it shows low aqueous solubility, poor dissolution and hence low oral bioavailability. In present study an attempt has been made to enhance the aqueous solubility of Cefpodoxime Proxetil and hence its availability in aqueous media. Solid dispersion (SD) of Cefpodoxime Proxetil using soluplus as carrier was prepared by solvent evaporation method. The prepared solid dispersion was characterized using FTIR, SEM, DSC and evaluated for In vitro drug release. FTIR and DSC results indicated chemical compatibility between drug and carrier. Moreover DSC thermogram of SD and pure drug suggested the change in crystallinity of Cefpodoxime Proxetil. SEM showed that the physical structure of Cefpodoxime Proxetil was modified from crystalline to amorphous. Dissolution rate of Cefpodoxime Proxetil, physical mixture and SD were found 46.3%, 65.04% and 91.04 % respectively Which concluded a significant improvement in in vitro drug release profile. Solid dispersion of Cefpodoxime Proxetil and soluplus prepared in 1:10 ratio by solvent evaporation method resulted in enhancement of aqueous solubility of Cefpodoxime Proxetil and hence improved dissolution. Download
    • Formulation and Evaluation of Rizatriptan Benzoate Orodispersible Tablets

      Oral disintegrating tablets have emerged as an alternative to the conventional oral dosage forms to improve the patient compliance. Due to problem in swallowing ability with age, the paediatric and geriatric patients complain of difficulty to take conventional solid dosage forms. The ODT’s are solid dosage forms that dissolve or disintegrate rapidly in the oral cavity. This results in solution or suspension without the need of water. The main objective of this work is to formulate and evaluate Rizatriptan Benzoate ODT’s using different concentration of super disintegrating agents like croscarmellose, Sodium Starch Glycolate (SSG), Crospovidone, Yellow potato starch. In this study uses different concentrations of diluents like Spry Dried Lactose, Avicel, Mannitol to optimize diluents concentration. After optimizing diluents concentration the study is continued by using different super disintegrating agents. Tablets were prepared by direct compression method and evaluated for hardness, thickness, friability, disintegration time, and percentage of drug release. The results indicated that formulation prepared with Crospovidone and Avicel: Mannitol (30:70) was found to be optimised which provides maximum drug release(100%) and minimum disintegration time (less than 10 second). Download
    • Formulation And Evaluation of Medicated Chewing Gum Containing Caffeine Salicylate

      Caffeine salicylate shows more CNS stimulant activity than caffeine along with mild analgesic and anti-inflammatory actions. Caffeine salicylate was synthesized in Pharmaceutical Chemistry Laboratory, Satara College of Pharmacy, Satara. Chewing gum formulation was prepared in tablet form by using direct compression method. Lecithin was used as an emulisifier and sorbitol as a softner and synthetic gum base along with other excipients. Nine different formulations were prepared by changing the concentration of emulsifier and softner. Evaluation of tablets i.e. diameter, thickness, friability, hardness, average weight, content uniformity, stickiness and dissolution study were performed. A 32 full factorial design was selected and the 2 factors were evaluated at 3 levels. The amount of sorbitol (X1) and lecithin (X2) were selected as independent variables and the dependent variables were hardness and percent drug release at 30 min (%DR30min). The data obtained was treated using Stat-Ease Design Expert 8.0.7.1 software and analyzed statistically using analysis of variance (ANOVA). Download
    • Formulation and Evaluation of Sustained Release Matrix Pellets of Antiviral Drug Lamivudine

      The objective of the study was to develop sustained release matrix pellets of Lamivudine, using various viscosity grades of hydroxyl propyl methyl cellulose as retardant polymers The pellets were prepared by extrusion spheronization technique. The pellets were evaluated for angle of repose, bulk density, compressibility index and hausners ratio and in vitro drug release studies. The pellets showed satisfactory flow properties, compressibility. The results of in vitro dissolution studies indicated that formulation F8 is the most successful formulation of the study and exhibited highest drug release in the initial hours and the total release pattern was very close to the theoretical release profile of pellets. The rate of drug release decreased with increased polymer concentration. It was found that HPMC viscosity had a significant impact on the drug release from the prepared sustained release matrix pellets. The decrease in the release rate was observed with an increase in the polymeric system.Plastizer concentration also affect the sphericity of pellets and also affect the release rate. Thus, sustained release matrix pellets of Lamivudine using polymers were successfully formulated, evaluated. Download
    • Formulation and In-Vitro Evaluation of Modified Release Delivery of Trazodone Hydrochloride Tablets

      The objective behind this study was to formulate and evaluate Modified release tablet of Trazodone hydrochloride by using different hydrophilic and hydrophobic polymers by Wet granulation technology and to study the effect of different concentrations of polymers on release rate from tablet. Tablets were prepared using carnauba wax as extra fine powder (8.5-28%), hydroxypropyl methylcellulose (HPMC) (2-14.5%), and polyvinyl pyrollidone (PVP K-30) (8.5-30%) as release retardant polymers. The FTIR and DSC analysis does not show any interaction of drug with Excipients. The formulation was optimized on the basis of acceptable pre and post compressional parameters and in-vitro drug release. The resulting formulations produced monolithic tablets with optimum hardness, consistent weight uniformity and low friability. The results of dissolution studies indicated that Batch F8 exhibited drug release of 99% at the end of 12h to provide sufficient concentration for achieving satisfactory therapeutic value for extended period of time. The drug release from Batch F8 formulation was sustained up to 12 h. Fitting in-vitro drug release data from optimized matrix formulation to first order followed by Korsmeyer’s-Peppas indicated that diffusion could be mechanism of drug release. Download
    • Formulation and Evaluation of Transdermal Patches of Duloxetine Hydrochloride

      The rationale of this study was to develop a matrix-type transdermal patches containing drug duloxetine HCl with different concentrations of hydrophobic polymeric systems (Eudragit RL-100 and RS-100) via the solvent evaporation method using 20% w/w of di-n-butyl phthalate (DBT) as plasticizer, 3% concentrations of DMSO used to increase the transdermal permeation of duloxetine HCl. The drug and polymers physicochemical compatibility were studied by means of FTIR and DSC. Formulated transdermal patches were evaluated for thickness, tensile strength, percent elongation, weight variation, drug content, flatness, folding endurance, water vapour transmission rate, percent moisture uptake, percent moisture content, percent swell-ability and ex vivo permeation studies. Ex vivo permeation studies of all preparations were done by Franz diffusion cells on human cadaver skin. From the experimental results obtained, F5 formulation has been selected as the best formulation. The in vitro permeation profiles of all formulations could be best expressed by Higuchi’s equation (R2 = 0.992 to 0.998) for the permeation of drug from a polymeric matrix, indicating the mechanism of drug release from the prepared films to be diffusion controlled. The results suggested that higher the quantity of eudragit RL 100 in the patch, the superior its strength, flexibility, drug release and skin permeation potential. Download
    • Formulation and Evaluation of Moisturizer Prepared from Natural Sources

      Moisturizers are bland oleaginous substances that are used to replace natural skin oils, to cover tiny fissures in the skin, and to provide a soothing protective film. Moisturizers are used in various diseases like Psoriasis, Menopause and in skincare during chemotherapy. The aim of this study is to formulate moisturizer using natural sources and evaluation of in vitro moisture retention. As. there is several disadvantages of chemical based moisturizer; so polymers, mineral oil, petroleum is replaced with Black sesame oil and Pure ghee as it have several benefits. Black sesame oil contains Vitamin E acts as excellent antioxidant which is useful as natural sunscreen moisturizer and Ghee has natural retinol (vitamin A) in it that helps in repairing skin. In-vitro moisture retention was compared between Black sesame oil, Pure ghee and glycerin. Both ingredients showed comparable moisture retention than the glycerin. Moisturizers are formulated using black sesame oil and pure ghee and; evaluated for various parameter. In-vitro comparison of moisture retention of natural moisturizers is done with marketed preparation and both preparations also showed moderate moisture. Download
    • Formulation And Evaluation Of Bilayer Floating Tablets Of Ciprofloxacin Hydrochloride

      The objective of the present study was to develop a bilayer floating tablet for ciprofloxacin HCL using direct compression method. Bilayer floating tablets were designed to prolong gastric retention time and increase the bioavailability of the drug. Bilayer floating tablets contains of two layers, immediate release layer and controlled release layer. Immediate release layer contains sodium starch glycolate as a super disintegrating agent and controlled layer contains HPMC K grade polymers as controlled release polymers .Sodium bicarbonate is used as a gas generating agent. The tablets were evaluated for physic-chemical properties such as Bulk density, tap density, hausner’s ratio, compressibility index, angle of repose , hardness, thickness, friability, drug content, floating lag time , floating duration and in- vitro drug release by dissolution studies. FT-IR studies revealed that there was no interaction between the drug and polymer used in the study. The formulation F8 tablets showed controlled and complete drug released over a period of 12 hrs. Download
    • Formulation and Evaluation of Topical Spray Containing Anti Acne Agent

      Objective: The objective of the present study was to formulate a novel topical spray containing Antiacne agent. Comprising drug and other non-toxic excipients (mixture of propane and butane) LPG as propellant. Study was designed to increase the absorption of drug from the human skin. Therefore clear clinical need exists for development of suitable formulation of drug that has improved permeability and absorption, with the potential transparent thin film with the once daily dosing. An optimum formulation was to be study for skin irritation study, in-vivo drug release and finally for stability study. Experimental work: The preformulation studies for drug was carried out and compatibility of drug in formulation with different excipients was checked. Solutions for topical sprays were filled in Aluminium containers fitted with continuous spray valve. Primary screening of variables like polymers, penetration enhancers and solvents were done by preparing trial batches. Final batches were prepared comprising of polymer Eudragit E100 (flim forming polymer), penetration enhancers such as IPM and PG act as plasticizer, solvent and co-solvent such as Iso Propyl alcohol and ethanol respectively. Prepared Tazarotene topical spray formulations were evaluated for different parameters. Tazarotene topical spray included determination of delivery rate, delivery amount, pressure test, drug content, minimum fill, leakage test, flammability, spray patterns, particles size, etc and as well as In-vivo Skin irritation study and In-vitro drug released, Finally, optimised formulation Was kept for stability study as per ICH guidelines. Results and discussion: Absence of physical and chemical incompatibility during compatibility study revealed that Tazarotene is compatible with container closure and excipients. Tazarotene topical spray formulation T6 was found to be the best formulation Evaluation data of different formulation for Physico-chemical test, performance test and ex-vivo diffusion studies indicated the effectiveness of IPM as penetration enhancer. T6 was further proved non irritant and stability study in accordance with ICH guidelines indicated that the optimised formulation was stable. Conclusions: A novel type of formulation comprised of Tazarotene, Eudragit E100, IPM and organic volatile and non-volatile solvents, was used to develop a new topical spray formulation. This novel topical spray formulation was transparent solution with good, early evaporation and ease of application. In addition the research results showed the resultant invisible thin film with excellent carrier and permeability enhanced effect of IPM on drug. Finally, skin irritation test proved that the spray formulation was safe to be used for topical delivery. In summary, the novel formulation of Tazarotene, Eudragit E100, IPM and other excipients may provide alternate dosage form to Tazarotene gel formulation. Download