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Rheological Studies and in Vitro Release Evaluation for Different Iraqi J Pharm Sci, Vol.20(2) 2011 Clotrimazole emulgel Preparation and Evaluation of Physical and, Rheological Properties of Clotrimazole Emulgel Yehia I. Khalil*,1 , Abeer H. Khasraghi* and Entidhar J. Mohammed* *Department of Pharmaceutics , College of Pharmacy , University of Baghdad , Baghdad , Iraq . Abstract Recently, emulgel has emerged as one of the most interesting topical preparations in the field of pharmaceutics. In this research clotrimazole was formulated as topically applied emulgel ; different formulas were prepared. The prepared emulgels were evaluated for their physical appearance , rheological behaviour , and in vitro drug release . The influence of the type of gelling agent (carbopol 934 and methyl cellulose), the concentration of both the emulsifying agent (2% and 4% w/w of mixture of span 20 and tween 20) and the oil phase (5% and 7.5% w/w of liquid paraffin) and the type of oil phase (liquid paraffin and cetyl alcohol), on the drug release from the prepared emulgels was investigated. Commercially available topical canestin® cream was used for comparison. All the prepared emulgels showed acceptable physical properties concerning colour, homogeneity, consistency, and pH value. Rheological studies revealed that all emulgels formulations exhibited a shear – thinning behaviour with thixotropy, indicating structural break down of intermolecular interaction between polymeric chains. Clotrimazole emulgels exhibited higher drug release than canestin® cream. The results of in vitro release showed that methyl cellulose – based emulgel gave better release than carbopol 934 – based one. Also it was found that the emulsifying agent concentration had the most pronounced effect on the drug release from the emulgels, followed by the oil phase concentration, which has a retardation effect, and finally the type of the gelling agent. It was suggested that the clotrimazole emulgel formulation prepared with methyl cellulose, with low concentration of oil phase (5%w/w liquid paraffin) and high concentration of emulsifying agent (4%w/w), showed an optimum formula for highest drug release (74.4% after three hours), which followed higuchi diffusion model with a diffusion-controlled mechanism. Key words: Emulgel , carbopol , methyl cellulose , clotrimazole الخﻻصة بززضا مستغزز مسجيﻻتينززً حد ززذ مستغ ززشمد مس ززيذﻻنية مستهتززة رمد مﻻعزز تلم مستى زز ً ت ززتب ثزززم مس زز ت ززيش مغ جيﻻتينً ستلدة مسك ىتشميتلصوم ، ي تم ت يش عذد مب مس يغ مستخ فة حتزل تزم تييزيم ثززم مستغز لد مسجيﻻتينيزة مستخ فزة مززب يزز مست هززش مسفيضيززلوي ، عزز ىي مﻻنغززيلبية ، وت ززشس مسززذوم ززلس مسجغززم حزززس تتزز دسمعززة تززدريش نززىا مس ىممززج مسجيﻻتينيززة )مسكلسبىبىم 434 ومستثيج عي ي ىص( وتشحيض حج مب عىممج مﻻع ﻻب )2% و 4% مب مضيج عز ل 22 و تزىيب 22( ومسطزىس مسضي زً )5% و5 5%مزب مس زشمنيب مسغزل ج( إ زلنة إسززً نزىا مسطزىس مسضي ز )مس ززشمنيب مسغزل ج و ح زىم مسغزي يج( ع ززً عزشعة ت زشس مسزذوم مززب مستغزز مسجيﻻتينززً وميلسن هززل مززض مستغ ززش مس جززلسي )حززشيم حلنغزز يب ( حلنززة مس ززيغ مست ززشة س تغزز مسجيﻻتينززً أظهززشد ل ص نيضيلويزة مي ىسزة م يزة بزلس ى ، مس جزلنظ ، مسيزىم ومﻷط مسهيزذسوجينً حتزل سزى ع م عزشعة ت زشس مسزذوم مزب حلنزة زيغ مستغ مسجيﻻتينً محثش مب مستغ ش مس جلسي ، حزس تم مس ىم ع ً ت شس من ج س ذوم س يغ مستثيج عي ي ىص ميلسنزة مزض زيغ مسكلسبىبىم 434 مي ل وجذ م تشحيض عىممج مﻻع ﻻب سه تدريش م ىظ ع ً عشعة ت شس مسذوم ي هل تشحيض مسطىس مسضي زً ، يز منه ي تج ع ً معلقة ت شس مسذوم ، وم يزشم نزىا مس لمزج مسجيﻻتينزً حززس وجزذ م نزىا مسطزىس مسضي زً مي زل يزةرش ع زً عزشعة ت زشس مسذوم يي شح بل مس يغة مسذوم ية س تغ مسجيﻻتينً مست شة بلع تلم مستثيج عي ي ىص مض مقج تشحيزض مزب مسطزىس مسضي ز )5% مزب مس شمنيب مسغل ج( و مع ً تشحيض مب عىممج مﻻع ﻻب )4%( ث مس يغة مستخ زلسة ﻹعطزل مع زً عزشعة س زشس مسزذوم )4 54%ب زذ رﻻث علعلد( حتل منهل ت ض ن شية ثيكىج ي م عشعة من شلس مسذوم ثً مسخطىة مست ذدة س شس مسذوم Introduction The array of formulations and consistency nature from solid through compositions employed for topical application semisolid to liquid. Drug substances are confounds attempts at categorization . By far seldom administered alone, but rather as part majority of commercial dermatologic drug of a formulation, in combination with one or products are formulated in an emulsion (or more adjuvant agents that serve varied and cream) base. Topical formulations apply a specialized pharmaceutical functions. Drugs wide spectrum of preparations both cosmetic are administered topically for their action at and dermatological, to their healthy or the site of application, or for systemic effects(2) diseased skin(1). These formulations range in 1 Corresponding author E- mail : [email protected] Received : 22/3/ 2011 Accepted : 16/7/2011 19 Iraqi J Pharm Sci, Vol.20(2) 2011 Clotrimazole emulgel Drug absorption through the skin is enhanced skin (15-18 ) . Many emulgels are available such if the drug substance is in solution, with a as commercial Voltaren emulgel (Novartis favorable lipid/water partition coefficient, and Pharma, Basle, Switzerland), containing nonelectrolyte. For the most part, diclofenac diethylamine.The aim of this study pharmaceutical preparations applied to the skin is to formulate emulgel containing are intended to serve some local action and, as clotrimazole using two types of gelling agent : such, are formulated to provide prolonged carpobol 934 and methyl cellulose and study local contact, with minimal systemic drug some variables that may affect the formulation absorption. Drugs applied to the skin for their such as the type of the gelling agent, local action include antiseptics, antifungal concentration of the emulsifying agent ,the agents, skin emollients, and protectants(3,4). concentration and the type of the oil phase on Stratum corneum (SC) is the outermost, and the rheological properties besides to the in least permeable, layer of the skin, it is a vitro release of the drug from the prepared formidable barrier for both water transport out emulgels and comparing all the obtained of the body and chemical inward permeation. results with a commercial available In fact, the majority of drugs do not appear to formulation (canestin® cream ) . penetrate the skin at a rate sufficiently high for therapeutic efficacy, and only the most potent Materials , Equipments and once with appropriate physicochemical characteristics is valid candidate for Methods (5) transdermal delivery . skin delivery is an Materials effective for targeting therapy for topical Clotrimazole powder , methyl paraben , dermatological disorder as in antifungal agents ( 6 ) and propyl paraben were supplied by Samara . Several antifungal agents are available on Drug Industry . Methyl cellulose , cetyl the market in different topical preparations alcohol , ptoassium dihydrogen phosphate , (e.g., creams, ointments, and powders for the and span 20 from ( BDH chemicals Ltd , Poole purpose of local dermatological therapy). One , England ). Carbopol 934 from ( J. T. BAKER of these antifungal agents is clotrimazole. , Indian). Tween 20 from (Merk – Schuncherdt Clotrimazole is 1-[(2-chlorophenyl) , Germany ) . Liquid paraffin from ( Riedel – diphenylmethyl]-1H-imidazole. It has (7,8) De Haen AG Seezle , Hannover ) . Ethanol and antifungal effect .It inhibits growth of disodium hydrogen phosphate from ( Gainland pathogenic dermatophytes .It shares with chemical company , factory RO AD , econazole, miconazole, first – choice status for Sandycroft , Deeside , Clwyd – U.K. ) . topical treatment of tinea pedis, tinea cruris, Triethanol amine and propylene glycol from and tinea corporis due to any of the a (Searle company Hopkin and Williams , forementional organisms, candidiases due to Chadwell health Essex , England ) and candida albicans . It is effective for the topical canestin® cream from Bayer Company. All treatment of vulvovaginal and oropharyngeal (8-10) other reagents were of analytical grade . candidiasis . For skin care, and the topical treatment of dermatological diseases, a wide Equipments choice of vehicles ranging from solid to Sartorius balance ( Werke- GMBH , semisolids and liquid preparations, is available type 2842 , Germany ) , electrical mixer ( to physician and patients. Within the major Janke and Kunkel , RF 16 ) , water bath ( groups of semisolid preparations, the use of Memmert , Germany ) , pH –meter (Henna transparent emugels has expanded, both in Instruments PH 211 Microprocessor , Italy ) , cosmetics and pharmaceuticals. Emulgel or USP dissolution apparatus , type 11 ( Copley gellified emulsion is stable one and better Scientific TLD , England ) , rotational vehicle for hydrophobic or water insoluble viscometer ( Fungilab , Spain ) , spectrometer ( (11) drugs . It is an emulsion either of the oil in Specord 40 , Analytikjena , Germany ) . water or water in oil type, which are gelled by mixing with a gelling agent (12). Oil in water Methods emulsions are most useful as water washable Preparation of carbopol and methyl cellulose drug bases and for general cosmetic purposes, gel while water in oil emulsions are employed Fifty grams of carpobol gel was prepared more widely for the treatment of dry skin and by dispersing one gram of carbopol powder in emollient applications (13,14) . Emulgels have a 49grams purified water with aid of moderate high patient acceptability since they possess speed stirrer ( 50 rpm ) , and then the pH was the advantages of both emulsions and gels. adjusted to 6 – 6.5 using triethanol amine (19). Therefore, they have been recently used as Also fifty grams of methyl cellulose gel was vehicles to deliver various drugs to the prepared by dispersing 3.5 grams of methyl 20 Iraqi J Pharm Sci, Vol.20(2) 2011 Clotrimazole emulgel cellulose powder in 46.5 grams of heated paraben and 0.01 gm of propyl paraben were purified water (80 °C) , and the dispersion was dissolved in 5 gm of propylene glycol and both cooled to room temperature and left overnight were mixed with aqueous phase . Both the oily to ensure hydration of the gel (20,21) .
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