Formulation and Evaluation of Albendazole Emulgel

Formulation and Evaluation of Albendazole Emulgel | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Formulation and Evaluation of Albendazole Emulgel Vishal Gupta, Vikas Kumar This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6765827/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract The current study focuses on the development and assessment of an albendazole (ABZ) emulgel to enhance the efficacy and patient compliance of topical medicine distribution. Albendazole, a broad-spectrum anthelmintic/antifungal drug, has historically had a variety of issues with oral administration, such as poor absorption and systemic side effects. To overcome these limitations, an emulgel formulation was developed that provides a controlled and extended release of albendazole via the skin. The emulgel was made by adding albendazole to a suitable oil-in-water emulsion, then gelling chemicals were added to give it a semi-solid form. The produced emulgel's physical properties, pH, rheological behavior, drug content, and in vitro drug release profile were evaluated. Stability tests were also performed on the emulgel to ascertain its longevity. In vitro drug release tests revealed a sustained release profile, indicating that the albendazole emulgel formulation can provide the medication for an extended period of time. The emulgel proved to be highly stable across a variety of storage conditions, ensuring its appropriateness for usage in therapeutic settings. The emulgel's enhanced skin penetration further demonstrated how well it works to facilitate the absorption of transdermal medications. Emulgel Albendazole Topical Medicine Emulsion Gel Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Introduction Emulgels are emulsions that are mixed with a gelling agent to create gels, either water-in- oil or oil-in-water. A more stable and effective delivery system for hydrophobic or weakly water-soluble medications is emulsified gel. [ 1 ] Because they offer the benefits of topical medication delivery and the antifungal efficacy of both gels and emulsions, they have a high acceptability rate among patients. Lipophilic medications are encapsulated in direct systems (oil in water), while hydrophilic drugs are encapsulated in reverse systems (water in oil). As a result, they have lately been utilized to apply a variety of hydrophobic medications topically. It is effective against a number of fungus species, including Candida albicans and Candida tropicalalis, which cause topical More than 25% of people with this illness also have candidiasis. Fungal infections associated to Candida are a prevalent skin condition that affects around two-thirds of the population at some point in their live. [ 3 ] Because topical gel formulations are less oily and are easier to remove from the skin, they offer an effective medication delivery method. Drug absorption through the skin from topical formulation entails the drug's escape from the formulation and penetration of the skin to the intended tissue. [ 2 ] Material and Method Preparation of Albendazole Emulgel Various gelling agents and penetration enhancers were used to create different formulations as mentioned in (Table 1). The procedure for producing gel in various formulations was the sole difference in the method. In each formulation, the emulsion was prepared in the same way. Guar gum and xanthan gum were dissolved in distilled water while being constantly stirred at a moderate pace to create the gel formulations. Span 20 was dissolved in light liquid paraffin to create the emulsion's oil phase, while Tween 20 was dissolved in filtered water to create the aqueous phase. Propylene glycol was used to dissolve the preservatives, but the medication. After dissolving albendazole in ethanol, the aqueous phase was mixed with both solutions. After heating the oily and aqueous phases to 70° to 80°C, the oily phase was gradually introduced to the aqueous phase and stirred constantly until it cooled to room temperature.[4] Table 1 Composition of Different formulation batches (%w/w) Ingredient Formulation 1 Formulation 2 Albendazole 1 gm 1 gm Guar Gum - 0.75 Xanther Gum 0.75 gm - Liquid Parafine 5 gm 5 gm Span 20 1 gm 1 gm Tween 80 0.5 gm 0.5 gm Propylene Glycol 5 ml 5 ml Ethanol 2.5 ml 2.5 ml Methyl Parabene 0.1 ml 0.1 ml Propyl Parabene 0.5 ml 0.5 ml Distilled Water Q.s. Q.s. Evaluation of Emulgel PHYSICAL EVALUATION The colour and homogeneity of the produced emulgel compositions were visually examined. Phase separation, grittiness, and consistency all are up to the mark. MEASUREMENT OF pH One of the most important variables in the assessment of emulgels is pH. The balance between the drug's ionized and unionized forms is influenced by pH levels, and the two forms would exhibit distinct penetration patterns. A pH meter (Fig. 1) was used to assess each formulation's pH, which was measured at room temperature as 7.66 and 7.21 for F1 and F2, respectively. DETERMINATION OF VISCOSITY Using a Brookfield viscometer (Fig. 2), the viscosity of several Albendazole emulgel formulations was measured at 25°C. Percentage of Torque is shown in image for F1 and F2 as 64.3 and 70.3 respectively. Eventhough result of the viscometer is 25720 cP (Centi-poise) and 28120 cP for F1 and F2 respectively. SPREADABILITY 48 hours after the emulgel was prepared, its spreadability was evaluated using a glass slide device and a wooden block. (Fig. 3) Two glass plates, each measuring 10 cm by 10 cm and weighing 125 g, were sandwiched with 1 g of the created emulgel. The amount of time needed for the upper glass plate to fully separate from the fixed glass plate was noted after a 25 g weight was put in a pan. The following formula was then used to determine the spreadability: S=M.L/T Where, S=Spreadability L=Length of the glass plate used M=Weight tied to the upper slide T=Time taken to separate slide completely from each other. Spreadability was measured in terms of g.cm/sec EXTRUDABILITY The technique used to assess the gel formulation's extrudability was based on the percentage of gel that was extruded from an aluminum bendable tube after applying the weight in grams needed to extrude a minimum 0.5 cm gel ribbon in 10 seconds. Extrudability improved with more quantity produced. Each formulation's extrudability was measured three times, and the average data were shown. The following formula was then used to determine the extrudability: Extrudability=Applied weight to extrude gel from tube (in gm)/Area (in cm 2 ) DRUG CONTENT DETERMINATION An ultraviolet (UV) spectrophotometer was used to test the drug content of the formulations. (Fig. 4) Methanol was used to dilute 1 ml of the emulsion to 20 ml, and phosphate buffer 7.4 was used to get the amount up to 100 ml. To create a solution of 10 mg/ml of albendazole, 2 ml of this solution was further diluted.[5] IN VITRO DRUG RELEASE STUDY The prepared emulgel's in vitro drug release investigations were conducted in a modified diffusion cell with a dialysis membrane. After being submerged in phosphate buffer solution (PBS) at a pH of 7.4 for nine to twelve hours, the membrane was carefully clamped to one end of the dialysis cell's hollow glass tube. Subsequently, 300 mg of emulgel was applied evenly onto the dialysis membrane. (Fig. 5) The receptor compartment was filled with 100 milliliters of PBS pH 7.4, which was employed as the dissolving media. The entire assembly was kept on a magnetic stirrer, and the temperature of the cell was controlled at 37 ± 0.5°C by constantly stirring the solution on the receptor side with a magnetic bead. At appropriate intervals, the sample (10 ml) was removed and replaced with an equivalent volume of brand-new dissolving media. Stability Studies: A stability study was conducted. The emulgel formulation that worked best was maintained between 37 ± 2°C and 60 ± 2°C. After a month, the samples were examined for drug concentration, pH, homogeneity, and physical characteristics (Table 3). Table 3 Stability Studies of F1 Formulation Parameters Period of studies in months 0 month 3rd month pH 7.66 7.66 Drug Content 41.18 40.37 Homogeneity +++Homogeneous +++Homogeneous Physical appearance Off-White Off-White Result It was discovered that every created formulation of Albendazole emulgel was homogenous, thick, and off-white in color. Table 4 displays the results. Using a pH meter, one may measure pH, which ranges from 7.21 and 7.66. All of the prepared emulgel formulations had viscosity. Spreadability: Using the parallel glass slide method, the spreadability of each emulgel formulation was assessed and determined to be good. Table 5 shows the grading. Extrudability was assessed using the appropriate technique, with results displayed in Table 4. Using a UV spectrophotometer, the drug content of Albendazole emulgel formulations was determined. Table 2 displays the outcomes. A five-hour in vitro drug release investigation was conducted in a Franz diffusion cell. F1 had the highest drug release (41.18). Graph 2 displays the time in minutes. Every emulgel formulation underwent a skin irritation investigation, and none of the formulations displayed any edema or irritation. stability tests carried out in compliance with ICH regulations. After three months, the pH, physical characteristics, and medication content of all formulations were assessed; these parameters did not change. Thus, it may be said that the formulations of emulgel were stable. Table 4: Physical Examination Formulation Color Phase Sepration Grittiness Homogeneity Consistency F1 Off-White No Phase Separation - +++ +++ F2 White No Phase Separation - +++ +++ Table 5 pH, Viscosity, Spreadability and Extrudability Formulation Color Phase Sepration Grittiness Homogeneity Consistency F1 Off-White No Phase Separation - +++ +++ F2 White No Phase Separation - +++ +++ CONCLUSION Based on the foregoing findings and discussion, it can be said that the physical qualities of the Albendazole emulgel formulations made with guar gum and xanthan gum were satisfactory. As it demonstrated the maximum drug release in both types of gelling agent, the optimized batch F1 of emulgel, with liquid paraffin in its low level and the emulsifying agent in its high level, turned out to be the formula of choice. The spreadability, extrudability, drug content, and drug release of xanthan gum-based formulations were shown to be more promising. Therefore, it can be concluded that a promising topical treatment for a variety of fungal infections is liquid paraffin-based Albendazole emulgel with a 1% concentration of natural gelling ingredient. Declarations Funding: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Conflicts of interest/Competing interests: The authors state no conflict of interest. Ethics approval: Not Applicable Consent to participate: Not Applicable Written consent for publication: Not Applicable Availability of data and material: Not Applicable Code availability: Not Applicable Authors' contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission. References Aziz AY, Hasir NA, Imran NB, Hamdan MF, Mahfufah U, Wafiah N, Arjuna A, Utami RN, Permana AD. Development of hydrogel-forming microneedles for transdermal delivery of albendazole from liquid reservoir. Journal of Biomaterials Science, Polymer Edition. 2023 May 24;34(8):1101-20. Abedin S, Karimi M, Jafariazar Z, Afshar M. Formulation, in-vitro and ex-vivo evaluation of albendazole loaded ufasomal nanoformulation for topical delivery. Journal of Drug Delivery Science and Technology. 2022 Oct 1;76:103726. Meena AK, Sharma K, Kandaswamy MU, Rajagopal S, Mullangi R. Formulation development of an albendazole self-emulsifying drug delivery system (SEDDS) with enhanced systemic exposure. Acta Pharmaceutica. 2012 Dec 31;62(4):563-80. Khule PK. Formulation and evaluation of itraconazole emulgel for various fungal infections. Asian Journal of Pharmaceutics (AJP). 2019 Feb 9;13(01). Shirsand SB, Para MS, Nagendrakumar D, Kanani KM, Keerthy D. Formulation and evaluation of Ketoconazole niosomal gel drug delivery system. International journal of pharmaceutical investigation. 2012 Oct;2(4):201. Table 2 Table 2 is available in the Supplementary Files section. Graphs Graphs are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files AlbendazoleEmulgel.jpeg Table2.docx Graphs.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6765827","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":472159478,"identity":"52cdf75a-51dc-4460-aeb4-ee5c4affd242","order_by":0,"name":"Vishal 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name=\"Emphasis\"\u003eEmulgels are emulsions that are mixed with a gelling agent to create gels, either water-in- oil or oil-in-water. A more stable and effective delivery system for hydrophobic or weakly water-soluble medications is emulsified gel.\u003c/span\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eBecause they offer the benefits of topical medication delivery and the antifungal efficacy of both gels and emulsions, they have a high acceptability rate among patients. Lipophilic medications are encapsulated in direct systems (oil in water), while hydrophilic drugs are encapsulated in reverse systems (water in oil).\u003c/span\u003e\u003c/p\u003e \u003cp\u003e \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eAs a result, they have lately been utilized to apply a variety of hydrophobic medications topically. It is effective against a number of fungus species, including Candida albicans and Candida tropicalalis, which cause topical More than 25% of people with this illness also have candidiasis. Fungal infections associated to Candida are a prevalent skin condition that affects around two-thirds of the population at some point in their live.\u003c/span\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/p\u003e \u003cp\u003e \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eBecause topical gel formulations are less oily and are easier to remove from the skin, they offer an effective medication delivery method. Drug absorption through the skin\u003c/span\u003e \u003c/p\u003e \u003cp\u003e \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003efrom topical formulation entails the drug's escape from the formulation and penetration of the skin to the intended tissue.\u003c/span\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/p\u003e \u003c/div\u003e "},{"header":"Material and Method","content":"\u003cp\u003ePreparation of Albendazole Emulgel\u003c/p\u003e\n\u003cp\u003eVarious gelling agents and penetration enhancers were used to create different formulations as mentioned in (Table\u0026nbsp;1). The procedure for producing gel in various formulations was the sole difference in the method. In each formulation, the emulsion was prepared in the same way. Guar gum and xanthan gum were dissolved in distilled water while being constantly stirred at a moderate pace to create the gel formulations. Span 20 was dissolved in light liquid paraffin to create the emulsion's oil phase, while Tween 20 was dissolved in filtered water to create the aqueous phase. Propylene glycol was used to dissolve the preservatives, but the medication. After dissolving albendazole in ethanol, the aqueous phase was mixed with both solutions. After heating the oily and aqueous phases to 70° to 80°C, the oily phase was gradually introduced to the aqueous phase and stirred constantly until it cooled to room temperature.[4]\u003c/p\u003e\n\u003cdiv\u003e\n \u003ctable id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 1\u003c/div\u003e\n \u003cdiv\u003e\n \u003cp\u003eComposition of Different formulation batches (%w/w)\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\"\u003e\n \u003cp\u003eIngredient\u003c/p\u003e\n \u003c/th\u003e\u003cth align=\"left\"\u003e\n \u003cp\u003eFormulation 1\u003c/p\u003e\n \u003c/th\u003e\u003cth align=\"left\"\u003e\n \u003cp\u003eFormulation 2\u003c/p\u003e\n \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eAlbendazole\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e1 gm\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e1 gm\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eGuar Gum\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e0.75\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eXanther Gum\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e0.75 gm\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eLiquid Parafine\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e5 gm\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e5 gm\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eSpan 20\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e1 gm\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e1 gm\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eTween 80\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e0.5 gm\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e0.5 gm\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003ePropylene Glycol\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e5 ml\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e5 ml\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eEthanol\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e2.5 ml\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e2.5 ml\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eMethyl Parabene\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e0.1 ml\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e0.1 ml\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003ePropyl Parabene\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e0.5 ml\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e0.5 ml\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eDistilled Water\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eQ.s.\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eQ.s.\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003eEvaluation of Emulgel\u003c/p\u003e\n\u003ch3\u003ePHYSICAL EVALUATION\u003c/h3\u003e\n\u003cdiv\u003e\n \u003cp\u003eThe colour and homogeneity of the produced emulgel compositions were visually examined. Phase separation, grittiness, and consistency all are up to the mark.\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003eMEASUREMENT OF pH\u003c/p\u003e\n\u003cp\u003eOne of the most important variables in the assessment of emulgels is pH. The balance between the drug's ionized and unionized forms is influenced by pH levels, and the two forms would exhibit distinct penetration patterns. A pH meter (Fig.\u0026nbsp;1) was used to assess each formulation's pH, which was measured at room temperature as 7.66 and 7.21 for F1 and F2, respectively.\u003c/p\u003e\n\u003cdiv id=\"Sec3\"\u003e\n \u003ch2\u003eDETERMINATION OF VISCOSITY\u003c/h2\u003e\n \u003cdiv\u003e\n \u003cp\u003eUsing a Brookfield viscometer (Fig.\u0026nbsp;2), the viscosity of several Albendazole emulgel formulations was measured at 25°C. Percentage of Torque is shown in image for F1 and F2 as 64.3 and 70.3 respectively. Eventhough result of the viscometer is 25720 cP (Centi-poise) and 28120 cP for F1 and F2 respectively.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003ch3\u003eSPREADABILITY\u003c/h3\u003e\n\u003cdiv\u003e\n \u003cp\u003e48 hours after the emulgel was prepared, its spreadability was evaluated using a glass slide device and a wooden block. (Fig.\u0026nbsp;3) Two glass plates, each measuring 10 cm by 10 cm and weighing 125 g, were sandwiched with 1 g of the created emulgel. The amount of time needed for the upper glass plate to fully separate from the fixed glass plate was noted after a 25 g weight was put in a pan. The following formula was then used to determine the spreadability:\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003eS=M.L/T\u003c/p\u003e\n\u003cp\u003eWhere, S=Spreadability\u003c/p\u003e\n\u003cp\u003eL=Length of the glass plate used\u003c/p\u003e\n\u003cp\u003eM=Weight tied to the upper slide\u003c/p\u003e\n\u003cp\u003eT=Time taken to separate slide completely from each other.\u003c/p\u003e\n\u003cp\u003eSpreadability was measured in terms of g.cm/sec\u003c/p\u003e\n\u003ch3\u003eEXTRUDABILITY\u003c/h3\u003e\n\u003cp\u003eThe technique used to assess the gel formulation's extrudability was based on the percentage of gel that was extruded from an aluminum bendable tube after applying the weight in grams needed to extrude a minimum 0.5 cm gel ribbon in 10 seconds. Extrudability improved with more quantity produced. Each formulation's extrudability was measured three times, and the average data were shown. The following formula was then used to determine the extrudability:\u003c/p\u003e\n\u003ch3\u003eExtrudability=Applied weight to extrude gel from tube (in gm)/Area (in cm\u003csup\u003e2\u003c/sup\u003e )\u003c/h3\u003e\n\u003cdiv id=\"Sec11\"\u003e\n \u003ch2\u003eDRUG CONTENT DETERMINATION\u003c/h2\u003e\n \u003cdiv\u003e\n \u003cp\u003eAn ultraviolet (UV) spectrophotometer was used to test the drug content of the formulations. (Fig.\u0026nbsp;4) Methanol was used to dilute 1 ml of the emulsion to 20 ml, and phosphate buffer 7.4 was used to get the amount up to 100 ml. To create a solution of 10 mg/ml of albendazole, 2 ml of this solution was further diluted.[5]\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\"\u003e\n \u003ch2\u003eIN VITRO DRUG RELEASE STUDY\u003c/h2\u003e\n \u003cdiv\u003e\n \u003cp\u003eThe prepared emulgel's in vitro drug release investigations were conducted in a modified diffusion cell with a dialysis membrane. After being submerged in phosphate buffer solution (PBS) at a pH of 7.4 for nine to twelve hours, the membrane was carefully clamped to one end of the dialysis cell's hollow glass tube. Subsequently, 300 mg of emulgel was applied evenly onto the dialysis membrane. (Fig.\u0026nbsp;5)\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv\u003e\n \u003cp\u003eThe receptor compartment was filled with 100 milliliters of PBS pH 7.4, which was employed as the dissolving media. The entire assembly was kept on a magnetic stirrer, and the temperature of the cell was controlled at 37 ± 0.5°C by constantly stirring the solution on the receptor side with a magnetic bead. At appropriate intervals, the sample (10 ml) was removed and replaced with an equivalent volume of brand-new dissolving media.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv\u003e\n \u003ctable id=\"Tab2\" border=\"1\"\u003e\u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003eStability Studies:\u003c/p\u003e\n \u003cdiv\u003e\n \u003cp\u003eA stability study was conducted. The emulgel formulation that worked best was maintained between 37 ± 2°C and 60 ± 2°C. After a month, the samples were examined for drug concentration, pH, homogeneity, and physical characteristics (Table\u0026nbsp;3).\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv\u003e\n \u003ctable id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 3\u003c/div\u003e\n \u003cdiv\u003e\n \u003cp\u003eStability Studies of F1 Formulation\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\"\u003e\n \u003cp\u003eParameters\u003c/p\u003e\n \u003c/th\u003e\u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003ePeriod of studies in months\u003c/p\u003e\n \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e0 month\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e3rd month\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003epH\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e7.66\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e7.66\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eDrug Content\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e41.18\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e40.37\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eHomogeneity\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e+++Homogeneous\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e+++Homogeneous\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003ePhysical appearance\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eOff-White\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eOff-White\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\n \u003c/div\u003e\n \n"},{"header":"Result","content":"\u003cp\u003eIt was discovered that every created formulation of Albendazole emulgel was homogenous, thick, and off-white in color. Table\u0026nbsp;4 displays the results. Using a pH meter, one may measure pH, which ranges from 7.21 and 7.66.\u003c/p\u003e\u003cp\u003eAll of the prepared emulgel formulations had viscosity. Spreadability: Using the parallel glass slide method, the spreadability of each emulgel formulation was assessed and determined to be good. Table\u0026nbsp;5 shows the grading.\u003c/p\u003e\u003cp\u003eExtrudability was assessed using the appropriate technique, with results displayed in Table\u0026nbsp;4. Using a UV spectrophotometer, the drug content of Albendazole emulgel formulations was determined. Table\u0026nbsp;2 displays the outcomes. A five-hour in vitro drug release investigation was conducted in a Franz diffusion cell. F1 had the highest drug release (41.18). Graph 2 displays the time in minutes. Every emulgel formulation underwent a skin irritation investigation, and none of the formulations displayed any edema or irritation. stability tests carried out in compliance with ICH regulations. After three months, the pH, physical characteristics, and medication content of all formulations were assessed; these parameters did not change. Thus, it may be said that the formulations of emulgel were stable.\u003c/p\u003e\u003cp\u003eTable 4: Physical Examination \u0026nbsp;\u003c/p\u003e\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003eFormulation\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003eColor\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003ePhase Sepration\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003eGrittiness\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003eHomogeneity\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003eConsistency\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003eF1\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003eOff-White\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003eNo Phase Separation\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003e+++\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003e+++\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003eF2\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003eWhite\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003eNo Phase Separation\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003e+++\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\"\u003e\n \u003cp\u003e+++\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003ctable id=\"Tab5\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 5\u003c/div\u003e\n \u003cdiv\u003e\n \u003cp\u003epH, Viscosity, Spreadability and Extrudability\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\"\u003e\n \u003cp\u003eFormulation\u003c/p\u003e\n \u003c/th\u003e\u003cth align=\"left\"\u003e\n \u003cp\u003eColor\u003c/p\u003e\n \u003c/th\u003e\u003cth align=\"left\"\u003e\n \u003cp\u003ePhase Sepration\u003c/p\u003e\n \u003c/th\u003e\u003cth align=\"left\"\u003e\n \u003cp\u003eGrittiness\u003c/p\u003e\n \u003c/th\u003e\u003cth align=\"left\"\u003e\n \u003cp\u003eHomogeneity\u003c/p\u003e\n \u003c/th\u003e\u003cth align=\"left\"\u003e\n \u003cp\u003eConsistency\u003c/p\u003e\n \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eF1\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eOff-White\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eNo Phase Separation\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e+++\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e+++\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eF2\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eWhite\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003eNo Phase Separation\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e+++\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\"\u003e\n \u003cp\u003e+++\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e"},{"header":"CONCLUSION","content":"\u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003e\u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eBased on the foregoing findings and discussion, it can be said that the physical qualities of the Albendazole emulgel formulations made with guar gum and xanthan gum were satisfactory.\u003c/span\u003e\u003c/p\u003e\n \u003cp\u003e\u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eAs it demonstrated the maximum drug release in both types of gelling agent, the optimized batch F1 of emulgel, with liquid paraffin in its low level and the emulsifying agent in its high level, turned out to be the formula of choice. The spreadability, extrudability, drug content, and drug release of xanthan gum-based formulations were shown to be more promising.\u003c/span\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eTherefore, it can be concluded that a promising topical treatment for a variety of fungal infections is liquid paraffin-based Albendazole emulgel with a 1% concentration of natural gelling ingredient.\u003c/span\u003e\u003c/p\u003e"},{"header":"Declarations","content":"\u003col\u003e\n \u003cli\u003eFunding: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.\u003c/li\u003e\n \u003cli\u003eConflicts of interest/Competing interests: The authors state no conflict of interest.\u003c/li\u003e\n \u003cli\u003eEthics approval: Not Applicable\u003c/li\u003e\n \u003cli\u003eConsent to participate: Not Applicable\u003c/li\u003e\n \u003cli\u003eWritten consent for publication: Not Applicable\u003c/li\u003e\n \u003cli\u003eAvailability of data and material: Not Applicable\u003c/li\u003e\n \u003cli\u003eCode availability: Not Applicable\u003c/li\u003e\n \u003cli\u003eAuthors\u0026apos; contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.\u003c/li\u003e\n\u003c/ol\u003e\n"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eAziz AY, Hasir NA, Imran NB, Hamdan MF, Mahfufah U, Wafiah N, Arjuna A, Utami RN, Permana AD. Development of hydrogel-forming microneedles for transdermal delivery of albendazole from liquid reservoir. Journal of Biomaterials Science, Polymer Edition. 2023 May 24;34(8):1101-20.\u003c/li\u003e\n\u003cli\u003eAbedin S, Karimi M, Jafariazar Z, Afshar M. Formulation, in-vitro and ex-vivo evaluation of albendazole loaded ufasomal nanoformulation for topical delivery. Journal of Drug Delivery Science and Technology. 2022 Oct 1;76:103726.\u003c/li\u003e\n\u003cli\u003eMeena AK, Sharma K, Kandaswamy MU, Rajagopal S, Mullangi R. Formulation development of an albendazole self-emulsifying drug delivery system (SEDDS) with enhanced systemic exposure. Acta Pharmaceutica. 2012 Dec 31;62(4):563-80.\u003c/li\u003e\n\u003cli\u003eKhule PK. Formulation and evaluation of itraconazole emulgel for various fungal infections. Asian Journal of Pharmaceutics (AJP). 2019 Feb 9;13(01).\u003c/li\u003e\n\u003cli\u003eShirsand SB, Para MS, Nagendrakumar D, Kanani KM, Keerthy D. Formulation and evaluation of Ketoconazole niosomal gel drug delivery system. International journal of pharmaceutical investigation. 2012 Oct;2(4):201.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Table 2","content":"\u003cp\u003eTable 2 is available in the Supplementary Files section.\u003c/p\u003e"},{"header":"Graphs ","content":"\u003cp\u003eGraphs are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Emulgel, Albendazole, Topical Medicine, Emulsion, Gel","lastPublishedDoi":"10.21203/rs.3.rs-6765827/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6765827/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eThe current study focuses on the development and assessment of an albendazole (ABZ) emulgel to enhance the efficacy and patient compliance of topical medicine distribution. Albendazole, a broad-spectrum anthelmintic/antifungal drug, has historically had a variety of issues with oral administration, such as poor absorption and systemic side effects. To overcome these limitations, an emulgel formulation was developed that provides a controlled and extended release of albendazole via the skin.\u003c/span\u003e \u003c/p\u003e \u003cp\u003e \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eThe emulgel was made by adding albendazole to a suitable oil-in-water emulsion, then gelling chemicals were added to give it a semi-solid form. The produced emulgel's physical properties, pH, rheological behavior, drug content, and in vitro drug release profile were evaluated. Stability tests were also performed on the emulgel to ascertain its longevity.\u003c/span\u003e \u003c/p\u003e \u003cp\u003e \u003cspan type=\"SmallCaps\" class=\"SmallCaps\" name=\"Emphasis\"\u003eIn vitro drug release tests revealed a sustained release profile, indicating that the albendazole emulgel formulation can provide the medication for an extended period of time. The emulgel proved to be highly stable across a variety of storage conditions, ensuring its appropriateness for usage in therapeutic settings. The emulgel's enhanced skin penetration further demonstrated how well it works to facilitate the absorption of transdermal medications.\u003c/span\u003e \u003c/p\u003e","manuscriptTitle":"Formulation and Evaluation of Albendazole Emulgel","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-06-18 06:48:56","doi":"10.21203/rs.3.rs-6765827/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"9a1ff138-8cbc-4cd8-bce8-769182e2e249","owner":[],"postedDate":"June 18th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-07-08T05:08:43+00:00","versionOfRecord":[],"versionCreatedAt":"2025-06-18 06:48:56","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6765827","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6765827","identity":"rs-6765827","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}