Formulation And Evaluation Of Ufasomal Topical Gel Containing Selected .

1y ago
8 Views
2 Downloads
2.01 MB
11 Pages
Last View : 18d ago
Last Download : 3m ago
Upload by : Shaun Edmunds
Transcription

Sree Lakshmi V et al /J. Pharm. Sci. & Res. Vol. 13(1), 2021, 38-48Formulation and Evaluation of Ufasomal Topical GelContaining Selected Non Steroidal Anti Inflammatory Drug(NSAIDs)Sree Lakshmi V *, Deepa Manohar R, Mathan S, Shaiju S DharanDepartment of Pharmaceutics, Ezhuthachan College of Pharmaceutical Sciences, Marayamuttom, Neyyattinkara,Trivandrum – 695124, Kerala, India.AbstractAimVesicular structures are systems, which can be expected to prolong the duration of the drug in systemic circulation, andreduce the toxicity by selective uptaking. The aim of the study is to formulate and evaluate ufasomal topical gel containingetodolac by lipid film hydration method. Ufasomes enhance the drug retention properties of drugs within the cell of the skinmembrane for long period of time.MethodsTopical ufasomal gel was prepared by lipid film hydration method using oleic acid as the major component. The topicalufasomal gel formulations of all batches were evaluated for physical appearance, percentage yield, drug content, entrapmentefficiency, viscosity and in vitro drug diffusion study.ResultsThe results of FTIR analysis indicated that the characteristic peaks of the drug, etodolac are unaltered and hence it wasconcluded that the drug and excipients were compatible. The data of in vitro drug release were fitted in kinetic models.Stability studies were carried out after 30 days on all the gel formulations and were found to have good stability.ConclusionThe study indicates that the topical ufasomal gel of etodolac can effectively improve the permeation of the drug through skinwith reduced toxicity due to the presence of fatty acid in the formulation which acts as a permeation enhancer. Also, theformulation can be used for targeting of the drugs at a site using surfactants which act by decreasing the rigidity andincreasing the fluidity of the vesicles.Keywords: Etodolac; Fatty acid vesicles; Oleic acid; Transdermal drug delivery system; Ufasome.INTRODUCTIONProper drug selection and effective drug delivery isrequired for a therapeutic outcome in an optimal range.The controlled drug delivery technology has progressedimmensely over the last six decades in the pharmaceuticalindustry. Lack of patient compliance is the major problemassociated with conventional drug delivery systems.In the past few decades, considerable attention has beenpaid to the development of novel drug delivery system.The basic goal of novel drug delivery system is to deliverthe drug in therapeutic amount at the appropriate site inthe body and to maintain the desired drug concentrationover a specified term of treatment[1].Vesicular drug delivery systems are particularly importantfor targeted drug delivery because of their ability tolocalize the activity of drug at the site of action therebylowering its concentration at the other sites in body andsimultaneously minimizing the undesirable side effects.Fatty acid vesicles have high penetration through thehydrophobic layer like skin, so they can be effectivelyused as carrier systems for various drugs.Ufasomes are unsaturated fatty acid vesicles. They aresuspensions of closed lipid bilayers that are composed offatty acids, and their ionized species (soap). They havebeen developed to enhance penetration of drug into viableskin through stratum corneum. This carrier system appearsto be promising for the efficient and targeted delivery ofdrugs[2].NSAIDs taken orally are transported to all parts of thebody through blood and thus high blood concentrations areneeded to achieve effective tissue concentrations at theparticular site of action. These high concentrations in thebody can lead to a number of adverse events that can beunpleasant or potentially serious (for example, dyspepsia,gastrointestinal bleeding). Topical NSAIDs arerecommended for direct application to the painful site toprovide local pain-relieving effect without the systemicadverse effects associated with oral NSAIDs.Ufasomes are vesicles of long chain unsaturated fattyacids obtained as a result of mechanical agitation ofevaporated film in the presence of buffer solution. Thefatty acid vesicles are colloidal suspension consisting offatty acids and their ionized species. It provides anefficient method for delivery to the site of infection,leading to reduced drug toxicity with less adverse effects.Fig 1: Structure of ufasome38

Sree Lakshmi V et al /J. Pharm. Sci. & Res. Vol. 13(1), 2021, 38-48In liposomes, phospholipids are used as the majorcomponent. Natural phospholipids are chemicallyheterogeneous and pure synthetic phospholipids are notyet available in reasonable quantities. The readyavailability of fatty acids is the major advantage ofufasomes over liposomes. The fatty acid vesicles can beformed not only from unsaturated fatty acids such as oleicacid, linoleic acid, but also from saturated fatty acid suchas octanoic acid and decanoic acid.Ufasome is the new approach to enhance drug permeationthrough the skin. Unsaturated fatty acids like linoleic acidand oleic acids are used as natural permeation enhancers inthe preparation of ufasomes. Surfactant is also used incombination with fatty acid which enhances the flexibilityof skin and improves the passage of drug via skinmembrane. Ufasomes enhance the drug retentionproperties of drugs within the cell of the skin membranefor a long period of time[4].MATERIALS AND METHODSThe drug Etodolac was obtained from Balaji Enterprises,Gujarat, India. Oleic acid, Tween 80, Methanol, Carbopol940, Triethanolamine were obtained from Yarrow ChemProducts, Mumbai, India.Formulation of ufasomesUfasomes were prepared by lipid film hydration methodusing rotary vacuum evaporator. Optimized concentrationof oleic acid, tween 80 and etodolac was dissolved inmethanol in a round bottom flask followed by evaporationof the solvent under vacuum using a rotary vacuumevaporator (600 mmHg, 100 rpm). For complete removalof any possible traces of methanol and also to prevent theformation of emulsion due to the residual organic solventthe completely dried film in rota evaporator was leftovernight which was then hydrated at ambient temperaturefor 1 h with phosphate buffer (pH 7.4). The preparedvesicles were then sonicated to form the uniform sizevesicular dispersion.Formulation of carbopol gel1% w/v of carbopol 940 was dispersed into purified waterwith the help of a vortex shaker and allowed to hydrate for4-5 h. The pH value of the gel was adjusted to 7.4 usingtriethanolamine. During preparation of the gel, to avoidany air entrapment, the solution was agitated slowly.Incorporation of Ufasomes in the gel base.Under gentle mechanical mixing for 5 min, drug gel wasprepared by using an equivalent amount of etodolacvesicular dispersion into the previously made carbopol gelin a 2 : 1 ratio.Evaluation of UfasomesShape and Surface MorphologyMorphological parameters including sphericity andaggregation of selected Etodolac loaded ufasomaldispersion were examined using Scanning ElectronMicroscopy (SEM). Prior to imaging, samples weredispersed in methanol and the mixture was drop castedonto a piece of silicon wafer and fixed with double sidedconductive tape. Further, samples were air dried andcoated with gold using a gold sputter. High resolutionimages of the ufosomes were visualized under highvacuum at an accelerated voltage of 20 keV.Drug Entrapment EfficiencyThe entrapment efficiency of the drug was determined byusing centrifugation at 4500 rpm for 3 h at roomtemperature. The supernatant was separated and the drugamount was calculated by using supernatant and whichcarried out by detection of entrapment efficiency at 223.5nm with UV spectroscopy. The amount of entrapmentdrug is determined as a percentage was estimated from thefollowing equation:𝐀𝐦𝐨𝐮𝐧𝐭 𝐨𝐟 𝐝𝐫𝐮𝐠 𝐞𝐧𝐭𝐫𝐚𝐩𝐩𝐞𝐝Entrapment efficiency (%) *𝐓𝐨𝐭𝐚𝐥 𝐚𝐦𝐨𝐮𝐧𝐭 𝐨𝐟 𝐝𝐫𝐮𝐠100Where: A Amount of drug added initially;B Amount of drug determined in the filtrate byspectrophotometricallyA-B Represents the amount of drug entrapped inthe formulation.Evaluation of Ufasomal GelPhysical EvaluationThe prepared ufasomal gels were examined for theirphysical properties by visual inspection of color, clarityand phase separation.Percentage YieldThe empty container was weighed in which the gelformulation was stored then again the container wasweighed with gel formulation. Then subtracted the emptycontainer weighed with the container with gel formulationthen it gives the practical yield. Then the percentage yieldwas calculated by the formula.𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐚𝐥 𝐲𝐢𝐞𝐥𝐝Percentage yield * 100𝐓𝐡𝐞𝐨𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐲𝐢𝐞𝐥𝐝Drug ContentWeighed 10 gm of gel formulation was transferred in 250ml of volumetric flask containing 20 ml of alcohol andstirred for 30 min. The volume was made up to 100 ml andfiltered. 1 ml of above solution was further diluted to 10ml with alcohol and again 1 ml of the above solution wasfurther diluted to 10 ml with alcohol. The absorbance ofthe solution was measured spectrophotometrically at 223.5nm. Drug content was calculated by the ���𝐞𝟏Drug content Dilution factor 𝐒𝐥𝐨𝐩𝐞𝟏𝟎𝟎𝟎Determination of pHWeighed 50 gm of gel formulation was transferred into abeaker and pH measurement of the gel was carried outusing a digital pH meter by dipping the glass electrodecompletely into the gel system to cover the electrode.SpreadabilityTwo sets of glass slides of standard dimensions weretaken. The gel formulation was placed over one of theslides. The other slide was placed on the top of the gel,such that the gel was sandwiched between the two slidesin an area occupied by a distance of 7.5 cm along theslides. 100 g weight of gel was placed on the upper slidesso that the gel between the two slides was presseduniformly to form a thin layer. The weight was removedand the excess of gel adhering to the slides was scrappedoff. The two slides in position were fixed to a stand39

Sree Lakshmi V et al /J. Pharm. Sci. & Res. Vol. 13(1), 2021, 38-48without slightest disturbance and in such a way that onlyupper slides to slip off freely by the force of weight tied onit. A 20 g weight was tied to the upper slide carefully. Thetime taken for the upper slide to travel the distance of 7.5cm and separated away from the lower slide under theinfluence of the weight was noted. Spreadability wascalculated by using the following formula:S m l/twhere, S - spreadabilitym - weight tied to upper slides (20 g)l - length of the glass slide (7.5 cm)t - time taken in secHomogeneity and GrittinessA small quantity of ufasomal gel was pressed between thethumb and the index finger. The consistency of theufasomal gel was noticed (whether homogenous or not), ifthere was any coarse particles appeared on fingers. Also,the homogeneity could be detected when a small quantityof the ufasomal gel was rubbed on the back of the hand.The grittiness of the prepared ufasomal gel was alsoobserved in the same manner.Viscosity MeasurementViscosity of gel was determined using Brookfieldviscometer (S-62, model LVDV-E) at room temperaturewith a spindle speed of viscometer rotated at 12 rpm.In Vitro Drug ReleaseIn vitro drug release studies were performed on a Franzdiffusion cell by applying cellophane membrane. 50 mlvolume of receptor zone was maintained with phosphatebuffer of pH 7.4. 1 g of gel formulation was spread ondonor compartment. The temperature of receptor cell wasmaintained at 37º C. Equal volumes of the sample weretaken at 15, 30, 60, 120, 180, 240, 300 and 360 minutesand maintained with equal volume of fresh phosphatebuffer solution. Each sample was determined byspectrophotometrically at 223.5 nm and % cumulativedrug release was calculated.Kinetic Study Dissolution profile modelingThere are several linear and non-linear kinetic models todescribe release mechanisms and to compare test andreference dissolution profiles which are as follows: Zero order kineticsDrug dissolution from pharmaceutical dosage forms thatdo not disaggregate and release the drug slowly (assumingthat area does not change and no equilibrium conditionsare obtained) can be represented by the followingequation:W0-W K0tWhere W0 is the initial amount of drug in thepharmaceutical dosage form at time t and k isproportionality constant.Dividing this equation by W0 and simplifying:Ft k0tWhere Ft 1- (Wt/W0) and Ft represents the fraction ofdrug dissolved in time t and k0 the apparent dissolutionrate constant or zero order release constant. First order kineticsThis type of model to analyze the drug dissolution studywas first proposed by Gibaldi and Feldman and later byWagner. The relation expressing this model:𝐤𝟏𝐭Log Qt Log Q0 𝟐.𝟑𝟎𝟑Where, Qt amount of drug released in time t, Q0 is initialamount of drug in the solution and K1 first order releaserate constant. Korsmeyer peppas modelKorsmeyer developed a simple, semi empirical model,relating exponentially the drug release to the elapsed time(t).𝑸𝒕 Ktn𝑸𝒂Where ‘K’ is a constant incorporating structural andgeometric characteristic of the drug dosage form and ‘n’ isthe release exponent.The release exponent can be obtained from the slope andthe constant (K) obtained from the intercept of thegraphical relation between logarithmic versions of left sideof the equation versus log t. Higuchi modelQt KHt1/2Where Qt the amount of drug released at time ‘t’KH Higuchi release rateThis is the most widely used model to describe drugrelease from pharmaceutical matrices. A linearrelationship between the square roots of time versusconcentrations indicates that the drug release follows strictfickian diffusion.Storage Stability StudiesThe stability studies of gel formulation were determined at40 2 C, 30 2 C and 5 2 C in glass container for 30 days.The gel formulations were checked in the change inphysical appearance and drug content was analyzed byapplying a spectrophotometrically at 223.5 nm andphosphate buffer used as blank.RESULTS AND DISCUSSIONDrug - Excipient Compatibility StudiesThe FTIR studies were carried out for pure drug, drugpolymer mixture and drug excipient mixtures. Spectrumof drug and excipients in figure 2, 3, 4, 5, 6, 7 and 8showed the prominent peaks with respect to functionalgroups. The spectrum of physical mixture of drug withpolymer and drug with excipients concluded that there isno significant interaction between the drug, polymer andexcipients. In the spectrum of drugs polymer mixture, thecharacteristic peak of drug was not altered.40

Sree Lakshmi V et al /J. Pharm. Sci. & Res. Vol. 13(1), 2021, 0125010007505001/cmFig 2: FTIR spectrum of .91603040003750ETO g 3: FTIR spectrum of Etodolac and Oleic 153.431540003750ETO g 4: FTIR spectrum of Etodolac and Tween 3734.19703801.7080302040003750ETO N3500325030002750250022502000175015001250Fig 5: FTIR spectrum of Etodolac and Methanol10007505001/cm41

Sree Lakshmi V et al /J. Pharm. Sci. & Res. Vol. 13(1), 2021, .11837.11788.89748.3845-1540003750ETO 01/cmFig 6: FTIR spectrum of Etodolac and Carbopol 06052.54537.540003750ETO ig 7: FTIR spectrum of Etodolac and X37503500325030002750250022502000175015001250Fig 8: FTIR spectrum of drug and excipients10007505001/cmFormulation DevelopmentFig 9: Ufasomal dispersion of EtodolacFig 10: Ufasomal gel of Etodolac42

Evaluation of UfasomesShape and Surface MorphologyThe external and internal morphology of ufasomaldispersion were studied by SEM. SEM photograph ofufasomal dispersion is shown in the Fig 11 and 12, inwhich the prepared ufasomal dispersion were sphericalwith roughly smooth surface.Entrapment efficiency(%)Sree Lakshmi V et al /J. Pharm. Sci. & Res. Vol. 13(1), 2021, 38-4885Entrapment efficiency of ufasomes80757065F1F2F3F4F5F6Formulation CodeFig 13: Entrapment efficiency of ufasomesEvaluation Of Ufasomal GelPhysical EvaluationThe physical evaluation of ufasomal gel was evaluated andthe results were tabulated in Table b. From the analysis ofthe results, the physical appearance of the ufasomal gelswere found to be clear, white and translucent.Sl.No.Fig 11: SEM image of ufasomal dispersion123456FormulationColour Clarity ntTable b: Physical evaluation of ufasomal gelPercentage YieldThe percentage yield of all ufasomal formulations wereperformed. The values obtained were in the range of87.52% and 99.53% were summarized in Table c. Theresults were depicted as a graph in Fig 14. The percentageyield was found to be higher in F4 which was 99.53%.Fig 12: SEM image of ufasomal dispersionDrug Entrapment EfficiencyDrug entrapment effieciency of different formulations wascalculated and the percentage entrapment of etodolacloaded ufasomes was found in the range of 74.33% and83.57% as given in Table a. The results were depicted as agraph in Fig 13. The entrapment efficiency was found tobe higher in F4 formulation which is 83.57 %.Sl.FormulationPerecentage yield (%)(* SD)No.Code1F193.33 0.232F299.46 0.113F393.32 0.154F499.53 0.075F594.6 0.136F687.52 0.31*Average of 6 determinants, SD Standard deviationPercentage yield (%)Table c: Percentage yield of ufasomal gel formulationsFormulationEntrapment EfficiencySl. No.Code(%)(* SD)1F174.33 0.162F276.54 0.183F378.19 0.194F483.57 0.135F580.44 0.056F681.44 0.11*Average of 6 determinants, SD Standard deviationTable a: Entrapment efficiency of ufasomePercentage yield of ufasomal gel100806040200F1F2F3F4F5F6Formulation CodeFig 14: Percentage yield of ufasomal gel43

Sree Lakshmi V et al /J. Pharm. Sci. & Res. Vol. 13(1), 2021, 38-48Drug ContentThe drug content of different formulations was determinedby UV spectroscopic method at a wavelength of 223.5 nm.The values obtained were in the range of 84.39% and99.32% as given in the Table d. The drug content wasfound to be higher in F4 which was 99.32%.Percentage drugcontent (%) (* SD)1F184.39 0.192F298.44 0.243F387.11 0.224F499.32 0.095F591.52 0.116F695.48 0.33*Average of 6 determinants, SD Standard deviationTable d: Percentage drug content of ufasomal gelformulationDetermination of pHThe pH values of all the formulations were determined asper the procedure. The values were in the range of 7.22and 7.42 and is summarized in Table e.Sl. No.Formulation CodeSl. No.Formulation CodepH (* SD)1F17.22 0.022F27.35 0.103F37.32 0.094F47.22 0.015F57.42 0.166F67.28 0.06*Average of 6 determinants, SD Standard deviationTable e: pH of ufasomal gel formulationsSpreadabilityThe spreadability of all the formulations were determinedas per the procedure. The values were in the range of19.64 and 28.33 and is summarized in Table f. Theformulation F4 is found to have highest spreadabilitywhich is 28.33g/cm/sec. This indicates that theformulation F4 will easily spread on the skin which willenhance the absorption of the drug through stratumcorneum.summarized in Table g. All the formulation of ufasomalgel was found to be homogenous without any grittiness.Sl.SpreadabilityFormulation CodeNo.(g/cm/sec) (* SD)1F123.80 1.682F222.61 1.693F319.64 1.254F428.33 2.355F520.53 1.266F626.66 2.36*Average of 6 determinants, SD Standard deviationTable f: Spreadability of ufasomal gel F4HomogenousNo5F5HomogenousNo6F6HomogenousNoTable g: Homogeneity and grittiness of ufasomal gelformulationsViscosity MeasurementThe viscosity of all the ufasomal gel formulations wasfound using Brookfield viscometer. The results weresummarized in the Table h.Sl.Formulation CodeViscosity (cps) (* SD)No.1F11886.33 0.472F21885.66 0.943F31891 0.814F41873 0.815F51880.66 0.946F61891.33 1.24*Average of 6 determinants, SD Standard deviationTable h: Viscosities of ufasomal gel formulationsThe viscosity of all batches of etodolac ufasomal gel wastested. The viscosity of all the formulations were evaluatedusing Brookfield programmable DV-E viscometer byusing spindle no: 62. Viscosity of various formulated gelswere found in the range of 1873 to1891 centipoises.Homogeneity and GrittinessThe homogeneity and grittiness of all the formulationswere determined as per the procedure. The values areIn Vitro Drug ReleasePercentage of drug release (%)(* SD)Time(min)F1F2F3F4F5000000158.4 0.1612.26 1.534.96 0.3814 0.989.66 0.793013.32 0.6725.33 1.0216.26 1.3721.2 1.2115.6 0.986026.2 0.5534.86 2.3623.06 2.1735.53 0.9722.16 0.6612038.45 0.9046.13 2.6343.53 2.2957.13 1.9345.01 1.3918047.06 1.3057.04 2.2755.60 1.1564.86 1.0562.86 2.1224055.40 2.9369.36 1.3559.13 2.3673.56 1.6773.86 2.2630061.56 0.8175.68 0.8865.80 0.8686.26 2.4183.76 1.3736065.68 0.8782.8 2.4068.86 2.0091.01 1.6986.1 2.22*Average of 6 determinants, SD Standard deviationTable i: In vitro drug release study of etodolac ufasomal gel.F608.56 0.6117.6 0.7835.26 1.5845.13 1.4754.73 1.0664.1 1.7467.13 1.3477.73 1.5844

Sree Lakshmi V et al /J. Pharm. Sci. & Res. Vol. 13(1), 2021, 38-48Percentage drug release (%)The in vitro drug release of the ufasomal gel was carriedout using franz diffusion cell apparatus with phosphatebuffer 7.4 for 6 h. The results obtained were tabulated inTable i. The plot of percentage cumulative drug release v/s9080706050403020100time (min) was plotted and depicted as shown in Fig 15and 16. In vitro drug release study was conducted on theformulations for 6 h and the highest drug release of91.01% was observed with formulation F4.F1-F3F1F2F30100200Time (min)300400Fig 15: In vitro drug release of formulation F1-F3Percentage drug release(%)100F4-F68060F440F520F600100200300400Time (min)Fig 16: In vitro drug release of formulation F4-F6Kinetic ModellingTime (min)cum %drugreleased% 413.748.99FormulationF4Zero orderR2 values0.926Squareroot timelog Cum% drugremaininglogtimelog Cum% le j: Pharmacokinetic values of the study% c modelsKorsmeyer-peppasFirst ordermodel0.9140.970Table k: R2 values of kinetic modelCube Rootof % 32.2472.563Higuchi model0.99045

Sree Lakshmi V et al /J. Pharm. Sci. & Res. Vol. 13(1), 2021, 38-48Cumulative % drug releasedZero Order kinetics150Zero Orderkinetics100y 0.2489x 12.25R² 0.9269500-22610141822Linear (ZeroOrder kinetics)26Time (Hrs)Fig 17: Zero order plotLog Cumulative % drugremainingFirst Order Kinetics3.0002.0001.000y -0.0022x 1.85R² 0.91450.000-2 2 6 10 14 18 22 26First OrderKineticsLinear (FirstOrder Kinetics)Time (Hrs)Fig 18: First order plotLog cumulative % drugreleasedKorsmeyer Peppas3.000KorsmeyerPeppas2.0001.000y 0.8137xR² 0.97010.0000.000 1.000 2.000 3.000Log TimeLinear (KorsmeyerPeppas)Linear (KorsmeyerPeppas)Fig 19: Korsemeyer peppas plotCumulative % drug releasedHiguchi100806040y 0.402xR² 0.99020HiguchiLinear (Higuchi)Log. (Higuchi)00.000 1.000 2.000 3.000 4.000 5.000Linear (Higuchi)SQRT of TimeFig 20: Higuchi plot46

Sree Lakshmi V et al /J. Pharm. Sci. & Res. Vol. 13(1), 2021, 38-48The diffusion profile of optimized formulation F4 wasfitted to zero order, first order, Korsmeyer – peppas modeland Higuchi model to ascertain the kinetic modelling ofthe drug release mechanism shown in Fig 17 to 20. Thecorrelation coefficient (R2) for the formulation usingdifferent kinetics equation is listed in Table k. It was foundthat the in vitro drug release of the optimized batch F4 wasbest explained by Higuchi plot as the plot show highestlinearity (R2 0.990). The R2 value was used to evaluatethe accuracy of fit. The formulation F4 provide best fit tothe Higuchi model.Storage Stability StudiesThe stability study of the optimized formulation (F4) wascarried out for 30 days at 40 2 C, 30 2 C and 5 2 C inglass container. After prolonged storage, the ufasomal gelof formulation F4 were evaluated for various parameterslike physical appearance, pH, drug content and percentagedrug release.DrugIn vitro drugcontentrelease (%)(* SD)(* SD)Clear and7.22 99.32 091.01 1.69colourless0.010.09Clear and7.20 99.24 3090.92 0.09colourless0.150.02*Average of 6 determinants, SD Standard deviationTable l: Stability study at 5 2 CDaysPhysicalappearancepH(* SD)DrugIn vitro drugcontentrelease (%)(* SD)(* SD)Clear and7.22 99.32 091.01 1.69colourless0.010.09Clear and7.24 99.24 3090.98 0.08colourless0.150.07*Average of 6 determinants, SD Standard deviationTable m: Stability study at 30 2 CDaysPhysicalappearancepH(* SD)DrugIn vitro drugcontentrelease(* SD)(%)(* SD)Clear and7.22 99.32 091.01 1.69colourless0.010.09Clear and7.24 99.31 3090.85 0.42colourless0.120.45*Average of 6 determinants, SD Standard deviationTable n: Stability study at 40 2 CDaysPhysicalappearancepH(* SD)Formulation F4 after 30 days of storage shows there is nomajor change in the formulation after the storage as initial.The study shows no major difference before and after thestorage and all are in the satisfactory range. Thereforeformulation remains stable for sufficient time after thestorage of 30 days.CONCLUSIONSIn the present study, an attempt was made to preparetopical ufasomal gel of etodolac. The ufasomal gel wasprepared using lipid film hydration method usingdifferent concentration of the penetration enhancer, oleicacid and surfactant, tween 80. Formulation F4 containsthe optimized fatty acid and surfactant concentrationbased on entrapment efficiency, drug content and drugrelease kinetics. Hence, formulation F4 was selected asthe best formulation. From the studies conducted, thefollowing conclusions were drawn. As per terizations of the formulations were performed andsatisfactory results were obtained. Also, the in vitro drugrelease of ufasomal gel was found to be the highest in theformulation F4 which is 91.01% 1.69 which proves itsability to enhance the bioavailability through its longerresidence time and increased permeation of the drugthrough skin.AcknowledgementsI express my deep gratitude to Prof. (Dr.) Shaiju S Dharan(Principal, Ezhuthachan College of PharmaceuticalSciences) for his kind considerations on number ofoccasions throughout my project work. I am also thankfulto Mrs. Deepa Manohar R (Asst. Professor, EzhuthachanCollege of Pharmaceutical Sciences) for her guidance,encouragement and suggestions rendered for thesuccessful completion of my project work. I am alsoindebted to Dr. Mathan S (Head, Department ofPharmaceutics), Prof. Janeera Beevi S (Head, Departmentof Pharmaceutical Chemistry), Dr. Merlin N. J (Director ofPG Studies) for their guidance and support. I express mysincere gratitude to Ezhuthachan College ofPharmaceutical Sciences, KUHS, Thiruvananthapuram,India, for the constant support throughout.REFERENCESKaur J, Jaiswal S. Recent advances in topical drug delivery .2016;6(7):6353-69.2.Patel SA. Review on ufasomes and vesicular drug delivery system.An International Journal of Pharmacy Research. 2013;9(1):32-43.3.Derry S, Moore RA. Topical NSAIDs for acute musculoskeletalpain in adults. Cochrane Database of Systematic Reviews. 2015:16.4.Jain S, Mahajan SC. Lipid Based Vesicular Drug Delivery Systems.Advances in Pharmaceutics. 2014:1-14.5.Patel DM, Jani RH. Ufasomes: a vesicular drug delivery.Systematic Reviews in Pharmacy. 2011;2(2):72-7.6.Nair AJ, George A. Ufasome: a potential phospholipid carrier as anovel pharmaceutical formulation. Int. Res. J. pharm.2014;5(4):250-3.7.Kaur LP, Guleri TK. Topical gel: a recent approach for novel drugdelivery. Asian Journal of Biomedical and PharmaceuticalSciences. 2013;3(17):1-5.8.Verma S, Singh S. Topical gels as drug delivery systems: a review.Int. J. Pharm. Sci. Rev. Res. 2013;23(2):374-82.9.Rastogi V, Yadav P. Transdermal drug delivery system: anoverview. Asian Journal of Pharmaceutics. 2012;6(3):161-70.10. Pawar PM, Solanki KP. Recent advancements in transdermal drugdelivery system. International Journal of Pharmaceutical andClinical Research. 2018;10(3):65-73.11. Kumar L, Verma S. Fatty acid vesicles acting as expanding horizonfor transdermal delivery. Artificial Cells, Nanomedicine andBiotechnology. 2019:1-9.12. Madhavi N, Sudhakar B. Design by optimization and comparativeevaluation of vesicular gels of etodolac for transdermal delivery.Drug Development and Industrial Pharmacy. 2019:1-20.1.47

Sree Lakshmi V et al /J. Pharm. Sci. & Res. Vol. 13(1), 2021, 38

Physical Evaluation . The prepared ufasomal gels were examined for their physical properties by visual inspection of color, clarity and phase separation. Percentage Yield. The empty container was weighed in which the gel formulation was stored then again the container was weighed with gel formulation.

Related Documents:

Evaluation of Formulation. WHAT DO WE MEAN BY: ‘PSYCHOLOGICAL FORMULATION’? Some definitions: Formulation is a provisional explanation or hypothesis of how an individual comes to present with a certain disorder or circumstance at a particular-point in time. (Weerasekera, 1996) A formulation is a tool used by clinicians to relate theory to practice . It is the lynchpin that .

Formulation Development and Evaluation of Enteric Coated Tablets of Rabeprazole Sodium B.Rama*, Shalem Raju Talluri, Grace Rathnam Department of Pharmaceutics, C. L. Baid Metha College Of Pharmacy, Chennai Abstract: Rabeprazole sodium is highly acid-labile and presents many formulation challenges and to protect it from acidic environment of the stomach an enteric coated tablet formulation is .

Formulation and evaluation of almotriptan chewable tablets 1V. Anil kumar*, K.L. Deepthi*, 1R. Kalyani, 1B. Padmasri, 2D.Prasanth . in the formulation of a chewable tablet is to obtain a complete profile of the active drug. This usually leads to the most efficient formulation of a stable and quality product as the drug usually dictates the choice of fillers, carriers, sweeteners, flavor .

Ravindran et al. / Formulation and Evaluation IJPCR, Volume 8, Issue 9: September 2016 Page 1306 Tween 80 Figure 1: Fruits of Dimocarpus longan. Formulation 1 Formulation 2 Figure 2: Formulated antioxidant creams The added to a free radical Chemicals 2,2 -Diphenyl-1-picryl hydrazyl (DPPH) was obtained from Sigma Aldrich Co, St Louis, USA .

uniformity of films, surface pH, disintegration time and in-vitro dissolution studies. The formulation F5 has disintegration time of 56 seconds and is more promising and showed drug release of 99.89%; hence formulation F5 was selected as best formulation. Keywords: Oral Films, Metoprolol Succinate, Solvent Casting Method. INTRODUCTION

mixed. Since formulation containing antimicrobial agents as active moiety, it is likely to protect from microbial growth 8, 9. To determine the activity of formulation is subject to study the prepared formulation with standard method called standard cup plate method and the inhibition zone diameters were measured with the help of zone reader.

Citation: Arunadevi Birajdar., et al. "Formulation and Evaluation of Antimicrobial Hair Gel from Abrus Precatorius". Medicon Pharmaceutical Sciences 1.3 (2021): 02-13. Formulation and Evaluation of Antimicrobial Hair Gel from Abrus Precatorius 03 Figure 1: Alopecia. Many herbal products have been praised for their hair growth-promoting activities [10].

Un additif alimentaire est défini comme ‘’ n’importe quelle substance habituellement non consommée comme un aliment en soi et non employée comme un ingrédient caractéristique de l’aliment, qu’il ait un une valeur nutritionnelle ou non, dont l’addition intentionnelle à l’aliment pour un but technologique dans la fabrication, le traitement, la préparation, l’emballage, le .