Film Batch Research Articles

Systematic characterization of new EBT4 radiochromic films in clinical x-ray beams

Objective. We aim to characterize kinetics of radiation-induced optical density in newly released EBT4 radiochromic films exposed to clinical x-rays. Several film models and batches were evaluated for the film sensitivity, optical signal increasing with time, relative film noise, and minimum detectable limits (MDL).Approach. Radiochromic film pieces from a single batch of EBT3 and three batches of EBT4 were exposed to doses of 77.38 cGy, 386.92 cGy, and 773.84 cGy using a 6 MV x-ray beam. The films were scanned with a flatbed scanner at specific time intervals up to 120 h. The time-series net optical density of red, green and blue colors was corrected for response of the scanner with time and studied to establish the saturation characteristics of film polymerization process. Dose-response from 3.86 cGy to 1935 cGy was also determined for each color. MDL of the films was quantitatively defined as the dose that would double the net optical density of red color above the standard deviation of the residual signal at zero dose. The relative noise characteristics of EBT3 versus EBT4 were studied as a function of time, dose and scanner resolution.Main Results. For doses ≥ 100 cGy, analysis revealed a stability of optical density beyond 48 h post-exposure for EBT3 and EBT4 films. EBT3 films attained 80%-90% of their net optical density at 48 h within minutes of irradiation, compared to 72%-88% for EBT4 films. The rate of growth was slowest for blue color, fastest for red, while green was in between the two. The MDL for EBT4 averaged 15 cGy for three batches, whereas EBT3 films reliably detected doses as low as 8.5 cGy.Significance. Several batches of the new EBT4 film showed slightly lower response compared to its predecessor over 3.86 cGy to 1935 Gy range. For all practical purposes, the post-irradiation growth of polymers ceases between 48 to 60 h for both EBT films. Overall, the EBT4 film exhibited noise characteristics similar to EBT3, except for lower doses where the noise was observed to be higher than its predecessor.

Optimization and Characterization of Mucoadhesive Buccal Films using Mimosa Seed-based Natural Polymer for Controlled Drug Release: A Sustainable Approach

Background: The present study attempted to develop cost-effective, biocompatible and biodegradable mucoadhesive buccal films exploring and using Mimosa pudica seed polymer, marking its potential as a sustainable drug delivery in pharmaceutical development. Methods: The extracted polymer was characterized for solubility, viscosity, loss on drying, pH, swelling index, starch, and mucilage ingredients. Compatibility between the polymer, drug, and excipients was assessed using FTIR analysis. Buccal film trial batches were formulated using the film casting technique and were optimized using the 23 full factorial design. Optimized formulation was characterized for drug release, permeability, mucoadhesive study, similarity, and difference factor along with histological and stability study. Results: The polymer’s pH, loss on drying, swelling index, and viscosity were 6.2, 6.8%, 81.77%, and 50,000 cP respectively. FTIR studies showed the compatibility between natural polymer, the model drug metoprolol succinate, and the excipients used. The early trial batches of polymeric films showed an extended drug release comparable to the standard polymers with a good permeability flux of 0.4048 ± 0.081 mcg*cm-2*h-1. The optimized film provided a controlled release of 52.31 ± 0.035% for more than 8 h following zero order kinetics. Mucoadhesive strength was found to be 32.25 ± 0.29 g. The similarity factor f2 (90.2) and difference factor f1 (8.197) indicated no significant difference compared to the standard formulation. Histological study demonstrated the non-irritant nature of the films and stability was established from the stability studies. Conclusion: Thus, a sustainable approach using natural polymeric buccal films was found promising for mucoadhesion and controlled release.

An Analysis of Changes in the Harmfulness of the Bottle Packaging Process Depending on the Type of Heat-Shrinkable Film.

This article shows an analysis of selected stages of a machine's life cycle environmental impact in the specific case of machines that package bottles in thermo-shrinkable film. As part of this analysis, laboratory tests were carried out to compare the performance properties of polyethylene films (with and without recycled material). Then, a life cycle assessment (LCA) was carried out within the specified system boundaries using the SimaPro program. Using the ReCiPe 2016 method, differences in the impact of the mass bottle packaging process on the categories human health, ecosystems and resources were determined depending on the shrink film used in the process. These tests showed that the tested batch of film with the addition of recyclates has similar functional properties to traditional ones and can therefore be used in the mass packaging process. The environmental analysis showed that changing the type of film to film with the addition of recyclates results in an almost 70% reduction in the potential negative impact of the process in terms of damage to health and ecosystems, and by 85% in terms of resources.

Molybdenum-Doped ZnO Thin Films Obtained by Spray Pyrolysis.

A batch of ZnO thin films, pure and doped with molybdenum (up to 2 mol %), were prepared using the spray pyrolysis technique on glass and silicon substrates. The effect of molybdenum concentration on the morphology, structure and optical properties of the films was investigated. X-ray diffraction (XRD) results show a wurtzite polycrystalline crystal structure. The average crystallite size increases from 30 to 80 nm with increasing molybdenum content. Scanning electron microscopy (SEM) images demonstrate a smooth and homogeneous surface with densely spaced nanocrystalline grains. The number of nuclei increases, growing over the entire surface of the substrate with uniform grains, when the molybdenum concentration is increased to 2 mol %. The estimated root mean square (RMS) roughness values for the undoped and doped with 1 mol % and 2 mol % of ZnO thin films, defined by atomic force microscopy (AFM), are 6.12, 23.54 and 23.83 nm, respectively. The increase in Mo concentration contributes to the increase in film transmittance.

Technology Transfer and Process Validation of Metformin Hydrochloride Immediate Release Tablet

Metformin Hydrochloride, inhibits the mitochondrial respiratory chain in the liver, leading to activation of AMPK, enhancing insulin sensitivity (via effects on fat metabolism) and lowering cAMP, thus reducing the expression of gluconeogenic enzymes. Metformin improves blood sugar levels by lowering the amount of glucose (sugar) that we absorb from our diet. It also helps stop the production of new glucose and improves insulin sensitivity. Metformin Hydrochloride is videly used in the form of sustained release formulation of Tablets. The study aimed to formulate and validate novel process for the Metformin Hydrochloride in immediate release pharmaceutical solid dosage forms. The wet granulation method used for formulation of Metformin Hydrochloride Immediate Release Tablets. Metformin Hydrochloride 500 mg, 850 mg, 1000 mg film coated tablets was prepared using FBE granulation technology on lab scale size. This study was carried out through a systematic plan; critical parameters were optimized to engender a stable & robust manufacturing process. The result of all three batches & its critical steps clearly shows consistency & reproducibility of parameters and all results. Hence the manufacturing method of Metformin Hydrochloride 500 mg, 850 mg, 1000 mg Film Coated tablets are validated at above parameters & equipments. Three validation batches of commercial scale batch size were taken successfully and monitored the in-process critical parameters for commercial batches. Metformin Hydrochloride tablets were manufactured within specified Limits for meeting all quality attributes and loaded for stability study. The overall successful three consecutive validation batches of Metformin Hydrochloride film coated tablets (500, 850 & 1000 mg) verifies the international technology transfer success.

Comprehensive evaluation and new recommendations in the use of Gafchromic EBT3 film.

Gafchromic film's unique properties of tissue-equivalence, dose-rate independence, and high spatial resolution make it an attractive choice for many dosimetric applications. However, complicated calibration processes and film handling limits its routine use. We evaluated the performance of Gafchromic EBT3 film after irradiation under a variety of measurement conditions to identify aspects of film handling and analysis for simplified but robust film dosimetry. The short- (from 5min to 100h) and long-term (months) film response was evaluated for clinically relevant doses of up to 50Gy for accuracy in dose determination and relative dose distributions. The dependence of film response on film-read delay, film batch, scanner type, and beam energy was determined. Scanning the film within a 4-h window and using a standard 24-h calibration curve introduced a maximum error of 2% over a dose range of 1-40Gy, with lower doses showing higher uncertainty in dose determination. Relative dose measurements demonstrated <1mm difference in electron beam parameters such as depth of 50% of the maximum dose value (R50 ), independent of when the film was scanned after irradiation or the type of calibration curve used (batch-specific or time-specific calibration curve) if the same default scanner was used. Analysis of films exposed over a 5-year period showed that using the red channel led to the lowest variation in the measured net optical density values for different film batches, with doses >10Gy having the lowest coefficient of variation (<1.7%). Using scanners of similar design produced netOD values within 3% after exposure to doses of 1-40Gy. This is the first comprehensive evaluation of the temporal and batch dependence of Gafchromic EBT3 film evaluated on consolidated data over 8years. The relative dosimetric measurements were insensitive to the type of calibration applied (batch- or time-specific) and in-depth time-dependent dosimetric signal behaviors can be established for film scanned outside of the recommended 16-24h post-irradiation window. We generated guidelines based on our findings to simplify film handling and analysis and provide tabulated dose- and time-dependent correction factors to achieve this without reducing the accuracy of dose determination.

Physical wedge as a tool for radiochromic film calibration

Reliable calibration is one of the major challenges in using radiochromic films (RCF) for radiation dosimetry. In this study the feasibility of using dose gradients produced by a physical wedge (PW) for RCF calibration was investigated. The aim was to establish an efficient and reproducible method for calibrating RCF using a PW. Film strips were used to capture the wedge dose profile for five different exposures and the acquired scans were processed to generate corresponding net optical density wedge profiles. The proposed method was compared to the benchmark calibration, following the guidelines for precise calibration using uniform dose fields. The results of the benchmark comparison presented in this paper showed that using a single film strip for measuring wedge dose profile is sufficient for estimating a reliable calibration curve within the recorded dose range. Furthermore, the PW calibration can be extrapolated or extended by using multiple gradients for the optimal coverage of the desired calibration dose range. The method outlined in this paper can be readily replicated using the equipment and expertise commonly found in a radiotherapy center. Once the dose profile and central axis attenuation coefficient of the PW are determined, they can serve as a reference for a variety of calibrations using different types and batches of film. This investigation demonstrated that the calibration curves obtained with the presented PW calibration method are within the bounds of the measurement uncertainty evaluated for the conventional uniform dose field calibration method.

Feasibility study of an inexpensive densitometry system for radiochromic film dosimetry

A readout system for radiochromic film dosimetry was developed based on the graphical system design approach, a broadband light-emitting diode, and a webcam. This digitizer works in transmission mode as the flatbed scanner used in dosimetry tasks, and the current clinical protocols were used to compare findings from both devices. Square samples of 3 cm were cut from an EBT3 film batch and irradiated to doses up to 50 Gy, sampling 100 pixels from each film image for noise, optical density, and uncertainty analysis. The imaging prototype has up to 2.2 times the optical density of the scanner, with a maximum of 1.7 corresponding to the red image channel. For both digitizers, the best noise rejection is in the green channel, ≈51 dB. The lowest uncertainty is in the scanner, with 1 % on average. Future efforts must focus on noise reduction to enhance image quality.

Development of formulation for taste masking of lamivudine as oral dosage forms and their evaluation

The purpose of the research is to figure out how to produce Lamivudine Film in a way that makes them taste; less unpleasant and dissolve quickly in the mouth. According to the results of Carr's index and Hausner's ratio, the flow properties of both model medications are quite subpar. According to the results of solubility tests, lamivudine dissolves quite successfully in 0.1 N HCl buffer. All of the evaluations described above were carried out with an all-fruit flavouring. The most recent round of testing consisted of using flavours such as strawberry and peppermint. Because of its delicious flavour, the strawberry flavour was voted the winner in this competition. Every batch of Film was analysed to determine if there were any differences in characteristics such as weight, hardness, thickness, and so on. The appearance of each batch of Films was evaluated and determined to be satisfactory across the board. Studies of in vitro dissolution were carried out on the best formulation, and the results revealed that one hundred percent of the drug was dissolved in 0.1N HCl after ten minutes had passed.

A Oral Fast Dissolving Films Containing Lyophilized Labetalol HCL with Hydroxy Propyl β-Cyclodextrin/ Soluplus: Formulation Development, In Vitro Evaluation

Introduction: Labetalol HCL is an antihypertensive drug used to treat high blood pressure in the long term management of angina. Labetalol HCL is readily absorbed after oral administration. Labetalol HCl undergoes considerable hepatic first-pass metabolism due to its lipid-soluble nature. &#x0D; Objective: The drug has an absolute bioavailability of approximately 25%. To overcome extensive hepatic first-pass metabolism the oral fast-dissolving film for labetalol HCL need to be developed. Lyophilized inclusion complexes of Labetalol HCL were developed with the hydrophilic carrier as Soluplus a Polyvinyl acetate polyethene glycol graft copolymer and Hydroxy Propyl β-cyclodextrin.&#x0D; Experimental: Lyophilized inclusion complexes of labetalol: Soluplus and labetalol HCL: HP-β-CD were prepared with 1:0.5 weight ratios. The prepared lyophilized inclusion complexes were evaluated for solubility estimation, drug content, and In-vitro dissolution study. &#x0D; Results: The prepared inclusion complexes were characterized by Fourier transforms infrared spectroscopy and differential scanning calorimetry. Characterization of the lyophilized complex showed changed crystallinity of labetalol HCL. The fast dissolving oral film of labetalol HCL was prepared by solvent casting method by adding film-forming polymer as HPMC K 4M/ PVA in different proportions and Propylene Glycol was used as a plasticizer. The prepared batches of films were evaluated for weight variation, tensile strength, folding, endurance, disintegration time, surface pH, and drug content uniformity. All formulations prepared among F5 and F 7 showed a better result as compared to other formulations. &#x0D; Conclusion: The study confirms the use of a lyophilized product containing Soluplus is best as that of HP-βCD for the preparation of fast dissolving film with HPMC/ PVA as film forming agent and propylene glycol as plasticizer respectively to improve dissolution rate and oral bioavailability of Labetalol HCl.

Evaluation of the transferability of an image analysis approach of X-ray micro-computed tomography images for the application with a new validation concept for in silico tools

It is possible to validate in silico tools for predicting quality attributes such as dissolution by using processed X-ray micro-computed tomography (XμCT) images of real pharmaceutical formulations as virtual matrices. Different batches of oral films were produced and imaged with XμCT. Over 30 million virtual matrices were evaluated and assessed. The highest performing image processing pathways were used for visual verification. The goal of this work was to assess the transferability of the concept of XμCT image based virtual matrices from tablets to oral films and to evaluate issues and limitations of the transferred concept to test feasibility. In principle, the images were suitable for usage in the validation concept but air bubbles in the oral films caused artefacts in the XμCT images which were identified by confocal Raman microscopy. The final processed images represented the raw images including the artefacts. Therefore, the virtual matrices based on films with air bubbles did not represent the real oral films and could not be used for the in silico calculations. The images of oral films without air bubbles were appropriate.

Eudragit® L100/chitosan composite thin bilayer films for intravaginal pH-responsive release of Tenofovir

The high rate of HIV new infections and AIDS-related deaths each year make prevention tools still necessary today. Different dosage forms – including films – for vaginal administration of antiretroviral drugs have been developed for this purpose. Six batches of Tenofovir-loaded films were formulated based on Eudragit® L100 (EL100) and chitosan, containing triethyl citrate and glycerol. In all the cases films structured in two layers – the upper layer mainly attributed to EL100 and the lower layer to chitosan – were revealed by SEM. A higher content in EL100 and plasticizers improves the mechanical properties and control over drug release in the vaginal medium without affecting mucoadhesion. The EL100-based layer acts as a structuring agent that controls Tenofovir release for days in the vaginal medium while it occurs in a few hours in the presence of seminal fluid. Bilayer films with the highest tested content of EL100 and plasticizers would be the most suitable as vaginal microbicides as they are easier to administer due to their excellent mechanical properties and they offer more comfortable posology and enhanced protection against HIV during intercourse due to their pH-responsive release of Tenofovir.

DOSE MAPPING OF GAMMA IRRADIATION CHAMBER (GIC)

The use of gamma rays to irradiate blood products have been demonstrated to reduce the probability of post-transfusion graft versus host disease. The aim of this study is to investigate the accuracy of a new batch of Gafchromic EBT-XD films to map the homogeneity of gamma radiation dose delivered to the blood bags and identify the lowest and highest levels of radiation exposure to the blood. The Gammacell 3000 Elan Gamma irradiation chamber (GIC) @ Blood Irradiator with Cesium-137 source was used. During the gamma irradiation at an exposure of 8 minutes 51 seconds to deliver a central dose of 25 Gy to the film, the EBT-XD films were placed at the centre of a blood-equivalent phantom. The doses then were measured using dose mapping analysis of Gafchromic EBT-XD film. The responses of EBT-XD films were compared with EBT3 films and GS 300 Dose Mapping Report 2021 prepared by Best Theratronics Dosimetry Laboratory, Canada. Results showed the value of doses obtained from the mapping using EBT-XD were reliable compared with the doses measured in EBT3 film as they were in the range of the acceptable dose ranges for blood irradiation procedures. The mapping with EBT-XD film yielded a minimum dosage of 18 Gy and a maximum exposure of 32 Gy at 8 minutes 51 seconds of irradiation. In conclusion, EBT-XD offered excellent dosimetric characteristics and has a the potential to dose map the blood irradiator.

Определение основных показателей качества и оценка лекарственных пленок, содержащих янтарную кислоту и цетилпиридиния хлорид

The main quality indicators and criteria for their acceptance for a medicinal film containing succinic acid and CPC were determined in accordance with the requirements of the current regulatory documentation. The quality of the pilot batches of the medicinal film was assessed in accordance with the developed quality indicators. As a result of the research, a draft regulatory documentation for the studied dosage form was developed – "Medicinal gum film containing succinic acid and cetylpyridinium chloride".

Rozrachunek z rokiem 1948 i jego następstwami w jugosłowiańskim i postjugosłowiańskim filmie fabularnym

The Yugoslav-Soviet political conflict began in 1948 and lasted for several years, constituting the second phase of the communist revolution in Yugoslavia. The es­sence of this phase is the de-Stalinization of the country and the emancipation of Titoism as an autonomous form of communism. The aforementioned phenom­ena are reflected in over a dozen feature films. The first ones were created at the turn of the 1940s and 50s. Though devised as propaganda materials, these works are artistically ingenious anti-Stalinist satires. Another batch of films appeared at the turn of the 1960s and 70s: their authors focus primarily on the victims of the de-Stalinization process. Films shot in the 1980s offer a look at 1948 and its aftermath in a broader time perspective, while at the same time emphasizing the problems of how political events influenced family ties. In the few films about de-Stalinization made after the fall of communism in Yugoslavia and the dissolu­tion of the state, a strong theme of the relationship between politics and religion can be observed.

Stereolithography-assisted fabrication of 3D printed polymeric film for topical berberine delivery: in-vitro, ex-vivo and in-vivo investigations.

3D printed polymeric film intended for topical delivery of berberine (BBR) was developed using stereolithography (SLA) to enhance its local concentrations. PEGDMA was utilized as photopolymerizing resin, with PEG 400 as an inert component to facilitate BBR solubilization and permeation. Three batches of topical films were printed by varying resin and PEG 400 compositions. In-vitro physicochemical characterizations of the 3D printed films were performed using several analytical techniques including ex-vivo drug permeation studies. In-vivo skin irritation studies were also conducted to assess the skin irritation potential. Films were 3D printed according to design specifications with minimal variations. Microscopic analysis confirmed 3D architecture, while thermal and X-ray diffraction studies revealed amorphous BBR entrapment. Drug permeation study showed effective ex-vivo diffusion up to 344.32 ± 61.20 µg/cm2 after 24.0 h possessing a higher ratio of PEG 400. In-vivo skin irritation studies have suggested the non-irritant nature of printed films. Results indicated the suitability of SLA 3D printing for topical application in the treatment of skin diseases. The presence of PEG 400 in the printed 3D films facilitated BBR diffusion, resulting in an improved flux in ex-vivo model and non-irritant properties in vivo.

Calibration of Gafchromic XR-RV3 film under interventional radiology conditions

Abstract Introduction: The purpose of the study was the calibration of Gafchromic films in clinical interventional radiology conditions and the assessment of the influence of dose range, the shape of the fitting curve, and its practical application. The aim of the work was to show how practically perform calibration in a wide range of doses. Material and methods: Gafchromic XR–RV3 films were included in the study. The calibration was performed for A and B film series separately. Doses from the range of 0 – 8 Gy were used. Film dosimeters were read out in reflective mode with a commercial flatbed scanner. Results: Among various degrees of a polynomial function, the best fit, which fulfilled the chosen criterion of 95% agreement between measured and reconstructed doses and simple equation criterion, was observed for third-degree polynomial. The fitting curve where the dose is the function of optical density (logMPV) was demonstrated to be more precise than the fitting curve based on MPV only. To minimize the difference between dose absorbed by the film and dose reconstructed from the fitting curve below 5% it is necessary to divide the calibration range of 0 – 8 Gy into two subranges for use in interventional radiology. This difference was set at a maximum level of 3.8% and 1.9% for the lowand high-dose range, respectively. Each series of films may have a slightly different calibration curve, especially for the low dose range. A deviation of up to 36% between two batches of Gafchromic film was observed. Conclusions: For the third-degree polynomial fitting function (one of the recommended in the literature) calibration should be done into low and high dose ranges and for each batch separately. A systematic error higher than 20% could be introduced when the fitting curve from one film batch is applied to the other film batch.

The Effect of Acid Modification of Porcine Mucin on Its Drug Release and Skin Permeation Properties in Insulin Transdermal Films

Background: The transdermal delivery of insulin involving the use of polymers has been extensively reported. More recently, the use of mucoadhesive or bioadhesive polymers as an insulin base in its formulation is gaining attention possibly due to the penetration enhancing properties of the polymers.&#x0D; Objectives: This study aimed at determining the effect of acid-modified porcine mucin powder on the release and permeation of insulin in transdermal films.&#x0D; Methods: Various batches of insulin films were prepared by solvent casting method using polysorbate 80 as an emulsifying agent and acid-treated and untreated mucin powders as a base. The films were evaluated for their physical properties, folding endurance, moisture content and uptake, drug content, bioadhesion, in vitro release, ex vivo permeation, and in vivo glucose-lowering activity.&#x0D; Results: The prepared insulin films had a weight range of 0.21-0.27 g, folding endurance of 101-103, moisture content and uptake of 13.73%-18.57% and 11.70%-22.30%, respectively, and drug content of 96%-101%. The bioadhesion of the films prepared with acid-treated mucin was within the range of 0.088-0.186 Nm-1 as against 0.055 Nm-1 of the films prepared with untreated mucin. The in vitro release profiles showed a release of 95% insulin from films prepared with untreated mucin within 2 h while the films made with acid-treated mucin gave a release of about 60%-73% over the same period, indicating a slower release. Animals that received acid-treated mucin-base insulin films showed delayed but sustained blood-glucose-lowering up to 70% and for films prepared with untreated mucin 55% within 12 h. &#x0D; Conclusion: Insulin transdermal films prepared with acid-modified mucin powder gave superior bioadhesive strength values. They also showed improved drug permeation enhancing ability and achieving up to 70% blood glucose lowering in diabetic rats.

Evaluation of Transdermal Formulations of Metoclopramide Prepared Using Arachis Oil and Liquid Paraffin as Permeation Enhancers

Background: The study aimed to evaluate the effect of arachis oil and liquid paraffin on metoclopramide release from transdermal films.&#x0D; Objectives: Batches of metoclopramide films were prepared with hydroxypropyl methyl cellulose (HPMC), arachis oil or liquid paraffin and Tween 80 as plasticizer. The films were evaluated for their physiochemical properties, in vitro and ex vivo drug release and drug release kinetics. Drug-excipient interactions were investigated using Differential Scanning Calorimetry (DSC) and Fourier Transform Infrared (FTIR) spectroscopy.&#x0D; Methods: The transdermal films had a weight range of 0.22-0.24 g, folding endurance of 300-306, percentage moisture content and uptake of 2%-10% and 19%-110%, respectively and drug content of 98%-104%. There was similar condition in vitro release profile for the films but their ex vivo profiles exhibited variable drug release with the P3 (30% arachis oil) giving the highest drug (almost 100%) release. &#x0D; Results: The release kinetics of metoclopramide followed the first order and Korsemeyer-Peppas models more closely as seen in their correlation coefficients (R2) of 0.9832 and 0.9560, respectively. Drug-excipient compatibility studies showed no interactions between excipients and metoclopramide.&#x0D; Conclusion: The formulated transdermal films showed controlled drug release over a period of 12 h. Arachis oil and liquid paraffin showed similar permeation enhancing ability. These enhanced permeation properties of the films could be helpful in the development of alternative route for metoclopramide administration in the management of emesis with improved patient acceptance.

Film Forming, Antimicrobial and Growth Promoting Wound Healing Spray Formulation

Background: Bacterial infections at wound site are one of the major causes for delayed healing. The aim of this study was to develop topical film forming spray having Combination of Simvastatin and Mupirocin which can avoid such infections and provide enhanced wound healing. Methods: Film forming spray formulation having Simvastatin and Mupirocin was formulated using Eudragit E100as film forming agent and Glycerol and Polyethylene glycol (PEG-400) as plasticizers. The effect of these excipients on the formulation was assessed by applying factorial design. Optimized formulation was evaluated for swelling index, spray angle, spray pattern, invitro drug release, evaporation time, average weight per dose, antimicrobial efficacy and in-vivo wound healing was assessed and compared with marketed formulation by excision wound healing model. Results: The optimized batch of topical film forming spray having combination of Simvastatin and Mupirocin was selected based on the results of swelling index and in-vitro drug release at respective drugs. Both the drugs gave more than 80% of drug release within 2 hrs and showed satisfactory physicochemical and mechanical properties along with potent antimicrobial efficacy against S. aureus and E. coli. Developed formulation showed comparative wound healing activity as that of marketed conventional formulation. Conclusion: Topical film forming spray was successfully developed using combination of Simvastatin and Mupirocin Calcium. Antimicrobial activity and results of animal studies indicated safety and efficacy of formulation.