Vaginal Film Research Articles

Fused Deposition Modeling-Based 3D Printing as a Versatile Technology to Manufacture Vaginal Films Incorporating Metronidazole

Fused Deposition Modeling-Based 3D Printing as a Versatile Technology to Manufacture Vaginal Films Incorporating Metronidazole

Preparation and in- vitro Evaluation of Bioadhesive Vaginal Film of Tinidazole

Bioadhesive vaginal film is becoming a more effective and convenient dosage form compared to suppositories and gel for vaginal application as a method for the treatment of vaginal infections. This study aimed to prepare and characterize bioadhesive films of tinidazole to be used for vaginal delivery over a prolonged period to treat local infections. Fourteen formulas of tinidazole films were prepared by solvent evaporation method. Each film was composed of 10 mg tinidazole with different ratios and concentrations of a polymeric combination of polyvinyl alcohol/ polyvinyl pyrrolidone (PVA/PVP) or polyvinyl alcohol/ hydroxypropyl methylcellulose (PVA/HPMC) for formulas A1-A7 and B1-B7, respectively. The prepared films were evaluated for their physicochemical characteristics, content uniformity, swelling, mucoadhesive strength, mucoadhesive time, and drug release. All the prepared films were transparent, had a uniform thickness (0.1-0.15 mm), and exhibited sufficient flexibility with drug content uniformity. The mucoadhesive strength of films was in the range of 28 ± 0.2 to 75 ± 0.01 g. Films containing PVA/HPMC showed higher swelling and lower mucoadhesive strength than those containing PVA/PVP polymeric combination. The in vitro drug release study showed no significant differences (p > 0.05) among films containing PVA/PVP or PVA/HPMC polymeric combinations. Formulas A3 and B4 were considered as the optimal bioadhesive films containing 3% of PVA: PVP (4:1) and 4% of PVA: HPMC (2:1), respectively as they showed complete flexibility, acceptable mucoadhesive strength and time (43 ± 0.1, 45 ± 0.23 g and 30 ± 0.02, 34 ± 0.01 min, respectively) and prolonged drug release rate. In conclusion, films of formulas A3 and B4 possess the potential as a delivery system for tinidazole for the treatment of vaginal infections at the site of application.

A crayfish chitosan-based bioactive film to treat vaginal infections: A sustainable approach

Polymicrobial communities are seen to be a sign of health, but they can turn detrimental when an excess of pathogenic species leads to recurring vaginal infections. This microbiological imbalance may decrease women's fertility, increasing also the risk of infection by Human Papillomavirus (HPV) and/or other sexually transmitted infections (STIs). There is a worldwide need for smart/sustainable solutions to tackle these types of infections. Hereupon, we investigated, as a potential solution, the use of crayfish chitosan-based membrane as a mucoadhesive, antimicrobial, biocompatible and biodegradable material. Chitosan was chemically extracted with a process yield of ca. 63 % and a degree of deacetylation of ca. 65 %. Further chitosan was characterized by FTIR, DSC, XRD and zeta potential. Antimicrobial and antioxidant activities were tested by microbicide concentration and ABTS methods. The extracted chitosan was confirmed to be antioxidant and antimicrobial against Escherichia coli, Candida albicans, Staphylococcus aureus (methicillin resistant and susceptible strains). Vaginal films using chitosan extracted from crayfish shells were produced by solvent casting, and the biological profile was tested in simulated vaginal fluid as a proof of concept. The main data showed that the vaginal films prepared were active against several microorganisms responsible for vaginal infections, demonstrating their potential in the field.

PROSPECTS FOR THE USE OF CONTRACEPTIVE VAGINAL PATCH ZB-06

With the high frequency of unplanned pregnancies in many countries, there is an urgent need for more affordable and effective contraceptives. In recent years, scientists around the world have been actively developing new methods of barrier contraception. This method is very simple and convenient due to the fact that it has no systemic effect, side effects are minimized, and a woman can use it when she needs it. In order to fill the gap in this niche, scientists have developed the ZB-06 vaginal contraceptive film containing the HC4-N human contraceptive antibody (HPA). Purpose. Study literature sources on the use of contraceptive vaginal film ZB-06. Materials and methods. Materials from PubMed and PubMedCentral resources of the US National Library of Medicine, Google Scholar, Elsevier Clinical Key and Elsevier Science Direct were used to analyze the literature. For the analysis of scientific literature, a qualitative method based on content analysis was used, namely, the definition of units of analysis - headings, annotations and keywords of articles; calculation of the frequency and percentage distribution of analysis units by analysis categories using the Excel program; interpretation and generalization of analysis results. Results. This review presents summarized research results that demonstrate that the ZB-06 contraceptive film has a number of advantages and disadvantages. This method of contraception provides effective levels of mucosal antisperm antibodies for at least 3 hours after use. Conclusion. Contraceptive vaginal film ZB-06 is an innovative, non-hormonal, topically applied vaginal film (containing HC4-N PPA), which in phase 1 of the study showed a high level of effectiveness and met the safety requirements for contraceptives.

Development of biopolymer films loaded with fluconazole and thymol for resistant vaginal candidiasis

Vulvovaginal candidiasis (VVC) is an opportunistic infection caused by a fungus of the Candida genus, affecting approximately 75 % of women during their lifetime. Fungal resistance cases and adverse effects have been the main challenges of oral therapies. In this study, the topical application of thin films containing fluconazole (FLU) and thymol (THY) was proposed to overcome these problems. Vaginal films based only on chitosan (CH) or combining this biopolymer with pectin (PEC) or hydroxypropylmethylcellulose acetate succinate (HPMCAS) were developed by the solvent casting method. In addition to a higher swelling index, CH/HPMCAS films showed to be more plastic and flexible than systems prepared with CH/PEC or only chitosan. Biopolymers and FLU were found in an amorphous state, contributing to explaining the rapid gel formation after contact with vaginal fluid. High permeability rates of FLU were also found after its immobilization into thin films. The presence of THY in polymer films increased the distribution of FLU in vaginal tissues and resulted in improved anti-Candida activity. A significant activity against the resistant C. glabrata was achieved, reducing the required FLU dose by 50 %. These results suggest that the developed polymer films represent a promising alternative for the treatment of resistant vulvovaginal candidiasis, encouraging further studies in this context.

3D-printed short nanofibers/hydrogel-based vaginal films as a novel system for the delivery of anti-HIV microbicide drugs

Acquired immunodeficiency syndrome (AIDS) is a global epidemic that affects the lives of millions of young women, particularly those who live in poverty-stricken regions and engage in unsafe sexual behaviors, forcing the development of unique pre-exposure anti-HIV prophylaxis tools. Using a combination of antiretroviral medications with various antiviral mechanisms significantly improves the prognosis for HIV patients. The integration of 3D printing technology, short nanofiber technology, and hydrogel into a single system known as “3D-printed nanocomposites” is an emerging approach that is gaining traction in tissue engineering, regenerative medicine, and biomedical applications. Based on these foundations, the current study aims to develop, for the first time, a 3D-printed short nanofiber/film for the vaginal delivery of ritonavir and efavirenz in a fixed-dose combination. To identify an optimal 3D-printable short nanofibers/hydrogel formulation, multiple formulations, and fragmentation methods were investigated. Following that, the generated vaginal films were evaluated using several physicochemical characterizations, mechanical properties measurements, and in vitro release studies. The findings revealed that only cryocutting is effective for polycaprolactone nanofiber fragmentation. The 3D-printed short nanofibers-loaded films had an ultimate tensile strength of 6.75 ± 1.27 MPa and elongation at break of 262.67 ± 44.32 MPa, suggesting their reliability for handling and vaginal application. Furthermore, the in vitro release study demonstrated that rapid EFZ release occurred during the first 45 min, whereas RIT release lasted more than 72 h, indicating that the complex drug release profile was met. In summary, the study emphasizes that 3D printing of short nanofiber-based films is likely to be an effective platform for localized vaginal drug delivery, particularly anti-HIV therapies.

Tenofovir vaginal film as a potential MPT product against HIV-1 and HSV-2 acquisition: formulation development and preclinical assessment in non-human primates.

Tenofovir (TFV) is an adenosine nucleotide analog with activity against HIV and HSV-2. Secondary analyses of clinical trials evaluating TFV gel as pre-exposure prophylaxis (PrEP) for HIV have shown that gel formulations of TFV provide significant protection against both HIV and HSV-2 acquisition in women who had evidence of use. An alternate quick-dissolving polymeric thin film, to deliver TFV (20 and 40 mg) has been developed as a potential multipurpose technology (MPT) platform. Film formulation was developed based on excipient compatibility, stability, and ability to incorporate TFV doses. Placebo, low dose (20 mg), and high dose (40 mg) films were utilized in these studies. The developed film platform efficiently incorporated the high dose of TFV (40 mg/film), released more than 50% of drug in 15 min with no in vitro toxicity. Pharmacological activity was confirmed in an ex vivo HIV-1 challenge study, which showed a reduction in HIV-1 infection with TFV films. Films were stable at both doses for at least 2 years. These films were found to be safe in macaques with repeated exposure for 2 weeks as evidenced by minimal perturbation to tissues, microbiome, neutrophil influx, and pH. Macaque sized TFV film (11.2 mg) evaluated in a pigtail macaque model showed higher vaginal tissue concentrations of TFV and active TFV diphosphate compared to a 15 mg TFV loaded gel. These studies confirm that TFV films are stable, safe and efficiently deliver the drug in cervicovaginal compartments supporting their further clinical development.

LALAPG variant of the Human Contraception Antibody (HCA) reduces Fc-mediated effector functions while maintaining sperm agglutination activity.

High rates of unintended pregnancies worldwide indicate a need for more accessible and acceptable methods of contraception. We have developed a monoclonal antibody, the Human Contraception Antibody (HCA), for use by women in vaginal films and rings for contraception. The divalent F(ab')2 region of HCA binds to an abundant male reproductive tract-specific antigen, CD52g, and potently agglutinates sperm. Certain other antibody activities mediated by the Fc region such as mucus trapping, complement-dependent cytotoxicity (CDC) and antibody-dependent cellular phagocytosis (ADCP) could have beneficial or negative effects. The purpose of this study was to document HCA Fc effector functions and determine whether an engineered variant of HCA with a modified Fc region, HCA-LALAPG, retains desirable contraceptive activity while minimizing Fc-mediated effects. Fab and Fc functions were compared between HCA and HCA-LALAPG. Fab activity was assessed using sperm agglutination and modified swim-up ("sperm escape") assays. Fc functions were assessed by CDC (sperm immobilization), ADCP, and cervical mucus penetration assays. HCA and HCA-LALAPG showed equivalent activity in assays of Fab function. In the assays of Fc function, HCA supported strong CDC, ADCP, and sperm trapping in cervical mucus whereas HCA-LALAPG demonstrated little to no activity. HCA and the HCA-LALAPG variant were both highly effective in the sperm agglutination assays but differed in Fc mediated functions. Use of the HCA-LALAPG variant for contraception in women could reduce antibody-mediated inflammation and antigen presentation but may have reduced contraceptive efficacy due to much weaker sperm trapping in mucus and complement-dependent sperm immobilization activity.

Women Want Choices: Opinions from the Share.Learn.Shape Global Internet Survey About Multipurpose Prevention Technology (MPT) Products in Development

Women need multipurpose prevention technologies (MPTs) to simultaneously prevent sexually transmitted infections (STIs), including HIV, with or without contraception. User feedback early in product development is critical for maximizing uptake and continuation. Our global online survey (April 2017–December 2018) explored women’s opinions about MPT formulations in development (e.g., fast-dissolving vaginal inserts, vaginal films, intravaginal rings, injectables, implants), preferences for long-acting or “on-demand” methods, and interest in a contraceptive MPT versus products for HIV/STI prevention alone. Of the 630 women in our final analysis (mean 30 years old; range 18–49), 68% were monogamous, 79% completed secondary education, 58% had ≥ 1 child, 56% were from sub-Saharan Africa and 82% preferred a cMPT versus HIV/STI prevention alone. There were no clear preferences for any specific product or product type (long-acting, on-demand, daily). No single product will appeal everyone, however, adding contraception is likely to increase uptake of HIV/STI prevention methods for most women.

ZB-06, a vaginal film containing an engineered human contraceptive antibody (HC4-N), demonstrates safety and efficacy in a phase 1 postcoital test and safety study

With an unplanned pregnancy rate of 50% or more in many countries, there is an urgent need for contraceptives that are more accessible and acceptable. To meet the growing demand for new contraceptives, ZabBio developed ZB-06, a vaginal film containing HC4-N, a human contraceptive antibody that inactivates sperm. This study aimed to assess the potential contraceptive activity of the ZB-06 film using a surrogate assessment for contraceptive efficacy, the postcoital test. We also assessed clinical safety of film use among healthy heterosexual couples. Serum, cervical mucus, and vaginal fluid HC4-N antibody concentrations and sperm agglutination potency were determined after single film use. Changes in the concentration of soluble proinflammatory cytokines and vaginal Nugent score after film use were measured as subclinical safety endpoints. This was a phase 1, first-in-woman, open-label, proof-of-concept, postcoital test and safety study. A total of 20 healthy women were enrolled in the study, and 8 heterosexual couples completed all study visits. The product was safe for both female participants and their male sexual partners. The postcoital test performed on ovulatory cervical mucus at baseline (no product use) revealed a mean of 25.9 (±30.6) progressively motile sperm per high-power field. After use of a single ZB-06 film before intercourse, this number dropped to 0.04 (±0.06) progressively motile sperm per high-power field (P<.0001). At the follow-up postcoital test visit approximately 1 month later (no product use), a mean of 47.4 (±37.4) progressively motile sperm per high-power field was observed, indicating contraceptive reversibility. A single dose of the ZB-06 film applied before intercourse was safe and met efficacy surrogate benchmarks of excluding progressively motile sperm from ovulatory cervical mucus. These data indicate that ZB-06 is a viable contraceptive candidate warranting further development and testing.

Disulfiram 3D printed film produced via hot-melt extrusion techniques as a potential anticervical cancer candidate

Cervical cancer is known globally as one of the most common health problems in women. Indeed, one of the most convenient approaches for its treatment is an appropriate bioadhesive vaginal film. This approach provides a local treatment modality, which inevitably decreases dosing frequency and improves patient compliance. Recently, disulfiram (DSF) has been investigated and demonstrated to possess anticervical cancer activity; therefore, it is employed in this work. The current study aimed to produce a novel, personalized three-dimensional (3D) printed DSF extended-release film using the hot-melt extrusion (HME) and 3D printing technologies. The optimization of the formulation composition and the HME and 3D printing processing temperatures was an important factor for overcoming the DSF heat-sensitivity issue. In addition, the 3D printing speed was specifically the most crucial parameter for alleviating heat-sensitivity concerns, which led to the production of films (F1 and F2) with an acceptable DSF content and good mechanical properties. The bioadhesion film study using sheep cervical tissue indicated a reasonable adhesive peak force (N) of 0.24 ± 0.08 for F1 and 0.40 ± 0.09 for F2, while the work of adhesion (N.mm) for F1 and F2 was 0.28 ± 0.14 and 0.54 ± 0.14, respectively. Moreover, the cumulative in vitro release data indicated that the printed films released DSF for up to 24 h. HME-coupled 3D printing successfully produced a patient-centric and personalized DSF extended-release vaginal film with a reduced dose and longer dosing interval.

Advanced Solid Formulations For Vulvovaginal Candidiasis.

Vulvovaginal candidiasis (VVC) is an opportunistic and endogenous infection caused by a fungus of the Candida genus, which can cause pruritus, dysuria, vulvar edema, fissures and maceration of the vulva. The treatment of vaginal candidiasis is carried out mainly by antifungal agents of azole and polyene classes; however, fungal resistance cases have been often observed. For this reason, new therapeutic agents such as essential oils, probiotics and antimicrobial peptides are being investigated, which can be combined with conventional drugs. Local administration of antimicrobials has also been considered to allow greater control of drug delivery and reduce or avoid undesirable systemic adverse effects. Conventional dosage forms such as creams and ointments result in reduced residence time in the mucosa and non-sustained and variable drug delivery. Therefore, advanced solid formulations such as intravaginal rings, vaginal films, sponges and nanofibers have been purposed. In these systems, polymers in different ratios are combined aiming to achieve a specific drug release profile and high mucoadhesion. Overall, a more porous matrix structure leads to a higher rate of drug release and mucoadhesion. The advantages, limitations and technological aspects of each dosage form are discussed in detail in this review.

Review of the current state of research in the field of film creation

A review of Russian and foreign literature on the current state of research in the field of creating ocular, oral, and vaginal films was carried out. The films development prospect for the prevention and treatment of various pathologies is shown.

Layer-by-layer vaginal films for acyclovir controlled release to prevent genital herpes

Genital herpes is one of the most common sexually transmitted infections worldwide. It mainly affects women, as the rate of sexual transmission from male-to-female is higher than from female-to-male. The application of vaginal antivirals drugs could reduce the prevalence of genital herpes and prevent future infections. Layer-by-layer vaginal films were prepared by the solvent evaporation method using iota-carrageenan, hydroxypropyl methylcellulose and the polymethacrylates Eudragit® RS PO and Eudragit® S100, for the controlled release of acyclovir. The films were characterized by texture analysis and Raman spectroscopy. Swelling, mucoadhesion, and drug release studies were conducted in simulated vaginal fluid. The results show that Layer-by-Layer films exhibited adequate mechanical properties. The structuring of the layer-by-layer films allowed the controlled release of acyclovir and produced a prolonged mucoadhesion residence time of up to 192 h. The films formed in layer 2 by the combination of Eudragit® RS PO and S100 showed a controlled release of acyclovir for eight days, and adequate mechanical properties. These promising formulations for the prevention of genital herpes deserve further evaluation.

Bictegravir nanomicelles and anionic pullulan loaded vaginal film: Dual mechanistic pre-exposure prophylaxis (PrEP) for HIV

Locally delivered pre-exposure prophylaxis (PrEP) has proven to be a promising strategy to combat Human immunodeficiency virus (HIV) transmission but several findings encountered toxicities or proved to be marginally effective in clinical settings. Therefore, innovative, multifunctional, and safer alternatives are being progressively investigated. Herein, we explored negatively charged carbohydrate, anionic pullulan (AP) as a rapidly soluble film-former and novel anti-HIV agent. Additionally, Bictegravir (BCT), an HIV integrase inhibitor was co-delivered in the form of nanomicelles for sustained antiviral activity. BCT-loaded PLGA-PEG polymeric nanomicelles (BN) were incorporated into PVA/pullulan-based film matrix comprising of 2 % w/v AP (BN-AP film). In cell-based assays, biocompatibility and TEER values for BN-AP films were similar to control while the commercial vaginal contraceptive film (VCF®) showed severe cytotoxicity and drastically reduced the tight junction integrity. Rapid disintegration of BN-AP film with >85 % drug release was observed in simulated vaginal and seminal fluid. Most importantly, AP and BN-AP film significantly inhibited HIV-1 replication with IC50 at as low as 91 μg/mL and 0.708 nM, respectively. Therefore, this study entails successful development of BN-AP film that functioned as an effective, biocompatible dual-acting PrEP formulation.

Optimized hydration dynamics in mucoadhesive xanthan-based trilayer vaginal films for the controlled release of tenofovir

Karaya gum, pectin and xanthan gum have been tested as candidates for manufacturing mucoadhesive trilayer films containing ethylcellulose and chitosan for the vaginal administration of the antiviral Tenofovir (TFV). The swelling profile correlated with the amount of mobile dipoles determined by impedance spectroscopy allows the determination of the hydration dynamics of these films. The fast water penetration has been demonstrated to favor the formation of polyelectrolyte complexes (PEC) via hydrogen or ionic bonds which would favor a controlled release. The incorporation of an inorganic drug release regulator induces the weakness of the polymeric chains thus enhancing the ionic mobility via the formation of low molecular weight PECs in films manufactured with karaya gum. Due to the different mechanical properties of the individual components, pectin-based films failed for a potential pharmaceutical formulation. However, mucoadhesive trilayer films produced with xanthan gum have demonstrated a moderate swelling, improved wettability and a controlled release of TFV.

Hexavalent sperm-binding IgG antibody released from vaginal film for development of potent on-demand nonhormonal female contraception

Nonhormonal products for on-demand contraception are a global health technology gap; this unmet need motivated us to pursue the use of sperm-binding monoclonal antibodies to enable effective on-demand contraception. Here, using the cGMP-compliant Nicotiana-expression system, we produced an ultrapotent sperm-binding IgG antibody possessing 6 Fab arms per molecule that bind a well-established contraceptive antigen target, CD52g. We term this hexavalent antibody "Fab-IgG-Fab" (FIF). The Nicotiana-produced FIF had at least 10-fold greater sperm-agglutination potency and kinetics than the parent IgG, while preserving Fc-mediated trapping of individual spermatozoa in mucus. We formulated the Nicotiana-produced FIF into a polyvinyl alcohol-based water-soluble contraceptive film and evaluated its potency in reducing progressively motile sperm in the sheep vagina. Two minutes after vaginal instillation of human semen, no progressively motile sperm were recovered from the vaginas of sheep receiving FIF Film. Our work supports the potential of multivalent contraceptive antibodies to provide safe, effective, on-demand nonhormonal contraception.

The use of objective adherence measures targeting four placebo microbicide delivery forms in the Quatro Clinical Crossover Study

AbstractBackgroundAdherence to topical microbicides for HIV prevention has been a challenge for women using them and those developing novel products. The Quatro Clinical Crossover Study investigated user preference and acceptability of four different placebo‐based vaginal delivery forms among young African women. The objective of this sub‐study was to test the ability of objective adherence measures in assessing placebo product usage.MethodsA total of two hundred women from Zimbabwe and South Africa used placebo vaginal gel, insert, and film once per week, with or without sex, for 1 month and an intravaginal ring continuously for one month (Months 1–4). Women then chose their preferred product and used it with sex each week during Month 5. Women self‐collected vaginal swabs after using the gel, insert and film. Collected vaginal swabs and used intravaginal rings were analysed for placebo‐based adherence measures using spectroscopy and excipient‐based analyses to determine product use. Vaginal insertion and semen exposure was determined using previously developed and published adherence biomarkers. Intravaginal rings were extracted for residual excipient (glycerin) and penetrated bioanalytes.ResultsBoth methodologies showed that women used gel the most during Months 1–4 (75% by excipient methods, 85% by spectroscopy). The methodologies also determined that nearly all swabs from both sites were vaginally inserted, and 51–86% had detectable placebo product. Semen was detected in more swabs collected during Month 5 from women in Zimbabwe than the swabs from women in South Africa, and most of those swabs had placebo product present as well. The majority of women used the ring for the required four weeks. Sixty‐eight per cent of women who used the ring for the required 4 weeks increased to 78% during Month 5.ConclusionThis sub‐study demonstrated how these objective placebo‐based measures of adherence determined product use of various microbicide delivery forms.

Development and optimization of a new tioconazole vaginal mucoadhesive film using an experimental design strategy. Physicochemical and biological characterization

A new tioconazole (TCZ) mucoadhesive film, based on a biodegradable chitosan/ hydroxypropyl methylcellulose (CH/HPMC) blend, was developed for treatment of vaginal candidiasis. The formulation was optimized through an I-optimal design (minimizing the integral of the prediction variance across the factor space), where the impact of the proportion of the ingredients and processing variables on the quality of the final product was evaluated. Both, the thickness of the film and the swelling index, which affect patients’ comfort and compliance, were considered. Mechanical testing, such as load at break, elongation at break, and mucoadhesive strength were also included as dependent variables.The optimal mucoadhesive film formulation, which should be obtained at a drying temperature of 30 °C, was found to include the combination of CH and HPMC (forming polymers) at 0.25:0.75 ratio, a mixture of polyethylene glycol 400 and propylene glycol as plasticizers (0.07:0.93, 5% w/w), and TCZ loaded at 15 % w/w.The optimal preparation was subjected to exhaustive characterization studies, which revealed that the drug was entrapped in the polymeric matrix in an amorphous state and that the film exhibited a smooth and uniform surface, demonstrating excellent component compatibility. In vitro tests showed that the formulation has an excellent time to kill value (3 min) and lacks cytotoxicity, suggesting that it should be highly effective and safe.

Development and validation of HPLC method for the quantification of clotrimazole in a gelatin film formulation

BackgroundClotrimazole is used to treat topical vaginal yeast infections. Vaginal gelatin film formulations of clotrimazole were prepared, and the present study aims to develop an HPLC method for quantifying clotrimazole in the film formulation.ResultsThe chromatographic separation of components was achieved on a Phenomenex Luna C18(2) (150 × 4.6 mm, 5 μm) stationary phase with Phenomenex Security Guard Cartridge C18 (4 × 3 mm) using acetonitrile and water (70:30% v/v) as mobile phase. The flow rate was 1.0 ml/min and the absorbance was monitored at 210 nm. Clotrimazole was eluted at 5.6 min. The procedures and capabilities of the method were evaluated against the criteria for system suitability, specificity, linearity, precision, accuracy, and robustness as defined by the ICH guidelines. The method showed good linearity (R2 = 0.999) in the range of 10–50 μg/ml and an average recovery of 101.05%.ConclusionThe method could be applied for the quantification of clotrimazole in the gelatin film formulation.