Academic literature on the topic 'Film forming formulation'

Film-forming formulations represent a novel form of sustained release dermatic products. They are applied to the skin as a liquid or semi-solid preparation. By evaporation of the volatile solvent on the skin, the polymer contained in the formulation forms a solid film. Various film-forming formulations were tested for their water and abrasion resistance and compared with conventional semi-solid formulations. Penetration and permeation studies of the formulations indicate a potential utility as transdermal therapeutic systems. They can be used as an alternative to patch systems to administer a variety of drugs in a topical way and may provide sustained release characteristics.

Objective: The aim of the present work was to formulate and evaluate fast dissolving film containing lornoxicam.Materials and Methods: To prepare the film, hydroxypropyl methylcellulose E5 and polyvinyl alcohol (PVA) were used as film-forming polymers by solvent casting method. Glycerine was used as plasticizer, aspartame, and mannitol as sweetener. All prepared films were evaluated for its weight variation, disintegration time, thickness, drug content, pH, dissolution study, and folding endurance. The drug-excipients compatibility study was done using differential scanning calorimetry (DSC) and Fourier transform infrared (FTIR).Results: Satisfactory results obtained when PVA was used as film-forming polymer, and the drug was dispersed in the polymer solution using poloxamer 407 as a solubilizing agent. Formulation F2 is considered as the optimized formulation as it showed good folding endurance (>300), faster disintegration rate (30 s), and maximum in vitro drug release (87%) within 5 min. DSC and FTIR studies showed no interaction between drug and the polymers.Conclusion: It can be concluded from the study that the fast dissolving film can be prepared for poorly water-soluble drug lornoxicam using PVA as a suitable film-forming polymer.

The objective of the present study is to formulate and evaluate Silk based film forming spray for wound healing. On the wound surface the solution solidifies into a film which can deliver the active moiety on site of action. The spray solution was prepared by simple mixing of active extract of Centella Asiatica, Silk Protein and various film forming polymers. Silk protein form scaffold for active fibroblast movement and Asiaticosides from Centella Asiatica extract improve and fasten collagen synthesis. A clear yellowish solution was obtained. The formulations (F1-F8) had a pH range between 5.5–6.5, which was close to the pH of skin. The viscosity of formulation in range of 25–50 cps, completely dry film formed within 5 min in open environment. The Effects of polymers, plasticizers and solvents on spreadability. Surface tension and Spray angle were studied. The high content of ethanol in the formulation fastens the drying time. The results indicated that formulation (F8) showed good spreadability and less drying time. Keywords: Film forming spray, Wound healing, Silk protein, Asiaticoside, Scaffold

Objective: The present study deals with the formulation and evaluation of fast dissolving buccal films for effective treatment option in the gastroesophageal reflux disease.Methods: Esomeprazole fast dissolving buccal films are a convenient formulation of which can be taken with or without water. In the present investigation, polyvinyl alcohol and polyvinylpyrrolidone were used as film-forming agents and polyethylene glycol 400 is taken as plasticizer. Solvent evaporation method was used for the preparation of fast dissolving buccal films.Results: The films were prepared and evaluated for film thickness, folding endurance, dispersion test, drug content, and dissolution. The in vitro dissolution studies were carried out using simulated salivary fluid (pH 6.8 phosphate buffer).Conclusion: Among all the formulations, Formulation E7 was released up to 99.6% of the drug from the film within 5 min of time which exhibits faster absorption and also shows desirable characteristics of the film. The drug-excipient interaction studies WERE carried out by Fourier-transform infrared studies, differential scanning calorimetry analysis-X-diffraction studies, and scanning electron microscopic studies and the results revealed that there were no major interactions between the drugs and excipients used for the preparation of films.

This research work was aimed to develop the telmisartan fast dissolving films. Fast dissolving films allow rapid drug dissolution in the oral cavity and thereby bypass the first pass metabolism. Solid dispersions of telmisartan using natural polymers such as hupu gum (HG), guar gum (GG) and xanthan gum (XG) were prepared by kneading technique and the optimized solid dispersion was exploited in the development of rapidly dissolving film. Telmisartan films were prepared by solvent casting method using different grades of HPMC (E5, 50 cps and K4M). Six formulations (FT1-FT6) of telmisartan films were prepared and evaluated for their physical characteristics such as thickness, tensile strength, percentage elongation, weight variation, folding endurance, drug content uniformity and surface pH and gave satisfactory results. The compatibility of the drug in the formulation was confirmed by FTIR and DSC studies. The formulations were subjected to disintegration, in vitro drug release and pharmacodynamic studies on spontaneous hypertensive rats (SHR). Amongst the formulations of FT1-FT6, FT6 was found as best formulation which contains HPMC E5 and telmisartan solid dispersion with guar gum at weight ratio of 1:2 and showed excellent film forming characteristics such as disintegration time at 42 sec and percentage drug release 97.98% within 10 minutes. The optimized film formulation (FT6) showed excellent stability over 45 days when stored at 40°C/60% RH. The pharmacodynamic study in SHR proved that fast dissolving films of telmisartan produced a faster onset of action.

The present work endeavors fabrication of fast dissolving buccal film of clonidine hydrochloride by employing quality by design (QbD) based approach. The total nine formulations were prepared according to formulation by design helped by JMP software 13.2.1. The patient oriented quality target product profiles were earmarked and on that basis critical quality attributes were identified. Preliminary screening studies along with initial risk assessment eased the selection of film-forming polymer (HPMC E 15) and plasticizer (PEG 400) as CMAs for formulation of films. A 32 full factorial plan was utilized for assurance of impact, i.e., HPMC E15 (X1) and PEG 400 (X2), as independent variables (factors) on thickness (mm) (Y1), disintegration time (s) (Y2), folding endurance (Y3), and tensile strength (kg) (Y4). Furthermore, prediction profiler assists in predicting composition of best formulation encompassing desired targeted response. The optimized formulation (F6) showed fast drug dissolution (>90%) within 8 min, and solid state characterization by DSC, XRD revealed excellent film characteristics. In a nutshell, the fast dissolving buccal film for clonidine hydrochloride was successfully developed assisted by QbD approach with markedly improved biopharmaceutical performance as well as patient compliance.

Objective: This study aimed to compare the characteristics of four buccal films formulated with phthalylated cassava starch and their drug deliverypotentials.Methods: An alternative to conventional (oral) drug administration is to administer drugs in a buccal film; however, the required dosage mustbe dissolved in a film-forming polymer with suitable mechanical and mucoadhesive characteristics. Previous studies have produced excipientsby physically and chemically modifying starch, such as by completely pregelatinization and phthalylation it in an aqueous medium under alkalineconditions (pH 8–10). This produced a pregelatinized cassava starch phthalate (PCSPh) powder with a high degree of substitution (0.0541±0.0019),thus giving it different physical, chemical, and functional characteristics than unphthalated PCS.Results: PCSPh in 4.5% and 6% (w/w) concentrations was used as excipients for producing four formulations of buccal film. One film had themost suitable characteristics, with an ex vivo mucoadhesion time of 57.1±20.3 min, tensile strength of 0.84±0.02 N/mm2, and a more rapid drugrelease profile than two of the other film types produced. Our tests also revealed that the best film tended to not change physically when moistened(percentage moisture absorption was 139% and moisture loss was 65%).Conclusion: Thus, we predict that PCSPh could be adequately formulated to provide mucoadhesive buccal films with an appropriate drug release profile.

The main aim of this study was to develop Povidone Iodine loaded film-forming gel for excellent wound healing property with various formulations, and corresponding application stratification was prepared with Povidone Iodine, polyethylene glycol-400, polyethylene glycol-4000, aloe vera, and honey. Povidone Iodine is a broad spectrum antiseptic for topical application in the treatment and prevention of infection in wounds. Among the antiseptic and antimicrobial substances, Povidone-Iodine still occupies its position of lasting importance in everyday human and veterinary medicine. Povidone-iodine products display the broadest spectrum of antimicrobial effect with high clinical efficacy together with extremely low toxicity in clinical practice. The purpose served by dressing includes protecting wounds, promoting healing, and providing, retaining, or removing moisture. Wound repairing is a complex process involving an integrated response by many different cell types and growth factors to achieve rapid restoration of skin integrity and protective function after injury. In recent years, there have been tremendous advances in the design and composition of bandages and dressings, and there are numerous wound care materials. Some wound dressing types are biosynthetic dressings, composite dressings, gauze, hydrocolloid dressings, hydrogels, transparent films, etc. Povidone Iodine is completely soluble in cold and mild-warm water, ethyl alcohol, Iso propyl alcohol, Polyethylene glycol, and glycerol. The developed Povidone Iodine loaded film-forming gel was evaluated for their physical and chemical stability. The film-forming optimized gel formulation composed of povidone-iodine, polyethylene glycol-400, polyethylene glycol-4000, aloe vera, and honey and this composition provides suitable consistency, spreadability, and adhesiveness. The prepared trials were coded PGAH-01, PGAH-02, PGAH-03, PGAH-04, and PGAH-05, respectively. Among these all formulations, the PGAH-04 formulation parameters was found within the limit.

Sumatriptan succinate is a 5-HT1B/1D receptor agonist which has well established efficacy in treating migraine. The main objective of the study was to formulate Oral Fast Disintegrating Films (ODF) and Oral Fast Disintegrating Tablets (ODT) to achieve a better dissolution rate and further improving the bioavailability of the drug. ODFs were prepared by solvent casting method using film forming polymers like HPMC – E15,5cps,50cps in different ratios & prepared batches of films were evaluated for the drug content, film thickness, disintegration time and in vitro dissolution studies. Among the prepared formulation F7 containing HPMC – 50cps (drug: polymer ratios = 1:1) was found to be best formulations which releases 98.2±1.1of the drug within 17±0.02 sec. ODTs prepared by direct compression method using in different concentrations of super-disintegrants. The prepared formulation T12 (combination of disintegrants) containing CP + CCS (6%) was considered to be the best formulation, which releases up to 100±0.38% of the drug in 23±0.75 sec, respectively. Based on these results, it is suggested that ODFs have faster disintegration time and drug release than ODTs.

Salbutamol is a short-acting, selective beta-2-adrenergic receptor agonist used in treatment of asthma and COPD. In the present work, sublingual films of Salbutamol sulphate were developed with a view to enhance the patient compliance and provide quick onset of action. Salbutamol has a bioavailability of 53 - 60%. The goal of the study was to formulate sublingual films of Salbutamol sulphate to achieve a better dissolution rate and further improving the bioavailability of the drug. Sublingual films prepared by solvent casting method using film forming polymers HPMC-E5, HPMC-E15 and Maltodextrin in different ratios. The prepared batches of films were evaluated for the drug content, weight variation, film thickness, disintegration time and in vitro dissolution studies. Among all, the formulation B1 containing HPMC-E15 with a drug: polymer ratio (1:6) was found to be the best formulation which showed 98.36% of the drug release within 15 minutes and disintegration time 18 sec. This study shows the viability of developing sublingual films of salbutamol.

Ce travail de thèse a pour objectif une meilleure connaissance des formulations filmogènes développées par les Laboratoires URGO. Deux aspects ont été développés.Il a tout d’abord été recherché un système d’encapsulation afin de protéger des molécules d’intérêt dans des solutions filmogènes. Des polymersomes en phase aqueuses et en phase organique ont été développés à base de copolymères amphiphiles m-PEG-PCL synthétisés et caractérisés au laboratoire. Ces auto-assemblages des copolymères possèdent des tailles variables (40 nm à 800 nm) avec une membrane en bicouche. Leur caractérisation a été réalisée en phase aqueuse et organique par différentes techniques : DLS, NTA, microscopie biphotonique et AFM. Puis des techniques de caractérisation ont été mises au point pour évaluer une formulation filmogène à base de nitrocellulose contenant de l’urée libre ou encapsulée dans des polymersomes. Cette formulation a été suivie au cours d’essais de stabilité à 25°C et à 40°C pendant 6 mois. Il a été observé une chute de viscosité, surtout à 40°C, attribuée à une coupure des chaînes macromoléculaires de la nitrocellulose (par CES). Les films formés ont un module de Young stable dans le temps avec apparition d’un jaunissement (paramètre b en colorimétrie). La quantité d’urée reste stable dans le temps mais elle accélère les phénomènes de vieillissement. Le jaunissement est dû à la décomposition de l’huile de ricin. L’encapsulation de l’urée au sein des polymersomes n’a pas amélioré la stabilité de la formulation prouvant ainsi le rôle catalyseur de l’urée
This work aims at a better understanding of film-forming formulations developed by Laboratoires Urgo. Two parts have been developed. First, an encapsulation system to protect a model drug in film forming solutions was investigated. Polymersomes in aqueous and organic media have been developed based on amphiphilic copolymers m-PEG-PCL which were synthesized and characterized in the laboratory. Auto-assemblies of copolymers display variable sizes (40 nm to 800 nm) with a bilayer membrane. Their characterization was carried out in aqueous and organic phase by various techniques: DLS, NTA, bi-photonic microscopy and AFM. In a second part, characterization techniques have been developed to assess a film forming solution based on nitrocellulose, containing free or encapsulated urea in polymersomes. This formulation was investigated during stability studies at 25°C and 40°C up to 6 months. A drop in viscosity was observed, especially at 40°C, due to cleavage of the macromolecular chains of nitrocellulose (SEC). The formed films have a stable Young's modulus over time with an appearance of yellowing (parameter b in colorimetry). The urea quantity remains stable in time, but accelerates the aging of the solution. Yellowing is caused by the decomposition of castor oil. The encapsulation of the urea within polymersomes did not improve the stability of the formulation thus proving the catalytic role of urea

The topical application of many substances, including drugs, enzymes, moisturizers and fragrances, contributes largely to the cosmetic and pharmaceutical industries. These components are often volatile in nature and dissipate in a matter of hours. When considering the different types of slow release systems, an overwhelming variety of these systems is available. Each one of the systems is unique in a way, and is designed to perform a particular function, whether it facilitates the controlled release of an active into the body via the skin surface (transdermal delivery) or whether it reduces the rate of loss of an active from the skin surface to the surrounding environment. For the purpose of this study, a previously existing fixative formulation which is believed to reduce the rate of loss of an active component to the environment, through film formation on the skin surface, was investigated. Alternative ingredients or components were incorporated together with the original fixative formulation ingredients into an experimental design which investigates the effect of each group of the components present. 18 formulations with various concentrations of the components within the groups and specified upper and lower limits for each component were formulated. The fixative properties of the formulations were analysed through the incorporation of a fixed amount of a simple fragrance molecule, 4- methoxybenzaldehyde, into each formulation and evaporation studies were conducted in an environmental room at 28±1° C over a period of 5 hours followed by gas chromatography analysis and finally data analyses using statistical methods. The most efficient fixative formulation was established using regression analysis. The fragrance compound in this formulation was found to evaporate at a rate of 0.47 g/L per hour. The least efficient fixative formulation lead to the loss of 0.78 g/L of the fragrance component per hour. From the calculated fragrance concentrations, the rate constant for each individual fixative formulation could be calculated and response surface 8 modelling by backward regression was used in order to determine how each component contributes to the rate of loss of the fragrance compound. Since the sum of the original ingredient and its alternative was constant, each of the original ingredients was coupled directly to its alternative and no conclusion could be made about the contribution of individual components. By increasing the concentration of Hydroxypropylcellulose (HPC) 100K and its alternative HPC 140K, while keeping the effects of the other components constant, a decrease in the rate of fragrance loss was observed. The same conclusion could be made when increasing the concentrations of PEG-12 Dimethicone and its alternative cetyl dimethicone (decreases the evaporation rate). An interaction took place between HPC 100K and PEG-12 dimethicone and their alternatives. The negative effect was, however, not as strong as the combined positive effect on the rate of fragrance loss of the individual components HPC and PEG-12 dimethicone. Evidence suggested that the removal of the components polyvinylpyrrolidone and its alternative, polyurethane-32 (Baycusan® C1003), would improve the effectiveness of the fixative formulation in terms of its slow release properties. A confirmation experiment established that the exclusion of these components from the fixative formulation does improve the “slow release” properties thereof. A larger, more intricate design is required to investigate the effect of each one of the individual components and where the sum of the components (original and its alternative) is not constant.

Abstract To create an adequate computational model of oil behaviour in an aeroengine bearing chamber previous work at the Gas Turbine and Transmissions Research Centre (G2TRC) suggests it is necessary to be able to model oil shedding from bearings, breaking up into droplets/ligaments and forming thin and thick films driven by gravity and shear. Our previously published work using Fluent successfully coupled volume of fluid with the Eulerian thin film model (ETFM) and identified the challenges coupling the ETFM with the discrete phase modelling (DPM). For this latter work comparison was made to published experimental and modelling data in which a jet is injected into a duct breaking up into droplets before forming a wall film. In this paper the use of the open-source CFD code OpenFOAM is investigated for this application recognising that such an approach eliminates some of the restrictions in a commercial product. A transient solver for spray particle cloud modelling and thin liquid film transport (sprayParcelFilmFoam) has been developed and incorporated within OpenFOAM. Fully coupled DPM-ETFM is presented, capable of modelling both primary atomization and secondary breakup. In addition two new film sub-models have been implemented for film stripping and edge separation. In order to achieve accurate statistical representation of droplets, modifications to the DPM particle injector code were implemented. CFD results are validated against published high speed imaging and phase Doppler experimental data and in addition there is a comparison to computational results obtained using ANSYS Fluent. The fidelity of both the solver and the novel surface film sub-models are evaluated against average film thickness measurements along the duct centreline. With the inclusion of both film stripping and edge separation, a normalized root mean squared deviation of 5.1 % was achieved when compared to film thickness measurements, improving significantly on the results obtained with Fluent. A comparison with experimental data of particle diameters and velocities downstream of the expansion edge gives good qualitative agreement. Future work is recommended to provide a better formulation for the edge-separated droplet diameters. Analysis of film momentum source terms highlights the necessity for including both the gas and hydrostatic pressure source terms within the film momentum transport equation. This CFD investigation has successfully established a fully coupled two-way DPM-ETFM approach. This work illustrates an advance in bearing chamber modelling capability and has established a necessary foundation for future aeroengine bearing chamber film modelling.

One of the challenges in the numerical simulation of a system of particles in a fluid flow is to balance the need for an accurate representation of the flow around individual particles with the feasibility of simulating the fully-coupled dynamics of large numbers of particles. Over the past few years, several techniques have been developed for the direct numerical simulation of dispersed two-phase flows. Examples include the ALE-FEM formulation described by Hu et al. [1] and the DLM method of Patankar et al. [2]. The former uses a finite element mesh that conforms to the shape and position of each particle and evolves dynamically as the particles move, while the latter employs a fixed mesh and constraints are imposed in the volume of fluid occupied by the particle to reproduce a corresponding rigid body motion. In both the aim is to fully resolve the flow dynamics for each particle and there is a corresponding demand for high resolution of the flow. A typical approach used for gas-solid flows has been the point-force method that combines a Lagrangian tracking of individual particles with an Eulerian formulation for force feedback on the fluid flow. The latter approach has worked well for very small particles in systems of negligible void fraction but significant mass loading. The resolution level is very low and often the particles are smaller than the spacing between grid points. Its success comes from the averaging effect of large numbers of small particles and the fact that the influence of an individual particle is weak. The approach though is inaccurate for liquid-solid or bubbly flows when the individual particles are of finite size and the void fractions may easily be larger than 1%. In tracking the individual particles an equation of motion is formulated that relates the particle acceleration to the fluid forces acting on the particle, and these forces such as drag and lift are parameterized in terms of the local fluid velocity, velocity gradients and history of the fluid motion. Once flow modification is included however, it is harder to specify the local flow. The parameterizations also become more complex as effects of finite Reynolds number or wall boundaries are included. As a numerical procedure, the force-coupling method (FCM) does not require the same level of resolution as the DLM or ALE-FEM schemes and avoids the limitations of the point-force method. It gives a self-consistent scheme for simulating the dynamics of a system of small particle using a fixed numerical mesh and resolves the flow except close to the surface of each particle. Distributed, finite force-multipoles are used to represent the particles, and FCM is able to predict quite well the motion of isolated particles in shear flows and the interaction between moving particles. The method also provides insights into how the two-phase flow may be described theoretically and modeled. The idea of the force-coupling method was first introduced by Maxey et al. [3]. The basic elements of the method are given by Maxey & Patel [4] and Lomholt & Maxey [5]. In the basic version of the method, fluid is assumed to fill the whole flow domain, including the volume occupied by the particles. The presence of each particle is represented by a finite force monopole that generates a body force distribution f(x,t) on the fluid, which transmits the resultant force of the particles on the flow to the fluid. The velocity field u(x,t) is incompressible and satisfies ∇·u=0(1)ρDuDt=−∇p+μ∇2u+f(x,t),(2) where μ is the fluid viscosity and p is the pressure. The body force due to the presence of NP bubbles is f(x,t)=∑n=1NpF(n)Δ(x−Y(n)(t)),(3)Y(n)(t) is the position of the nth spherical particle and F(n)(t) is the force this exerts on the fluid. The force monopole for each particle is determined by the function Δ(x), which is specified as a Gaussian envelope Δ(x)=(2πσ2)−3/2exp(−x2/2σ2)(4) and the length scale σ is set in terms of the particle radius a as a/σ = π. The velocity of each particle V(n)(t) is found by forming a local average of the fluid velocity over the region occupied by the particle as V(n)(t)=∫u(x,t)Δ(x−Y(n)(t))d3x.(5) If mP and mF denote the mass of a particle and the mass of displaced fluid, the force of the particle acting on the fluid is F(n)=(mP−mF)(g−dV(n)dt).(6) This force is the sum of the net external force due to buoyancy of the particle and the excess inertia of the particle over the corresponding volume of displaced fluid. In addition a short-range, conservative force barrier is imposed to represent collisions between particles and prevent overlap. A similar barrier force is imposed, normal to the wall, to represent collisions between a particle and a rigid wall. With this scheme the body forces induce a fluid motion equivalent to that of the particles. The dynamics of the particles and the fluid are considered as one system where fluid drag on the particles, added-mass effects and lift forces are internal to the system. The method does not resolve flow details near to the surface of a particle, and indeed the no-slip condition is not satisfied on surface. At distances of about half a particle radius from the surface the flow though is fairly well represented. While there is no explicit boundary condition on the particle surface, the condition (5) ensures that the bubble and the surrounding fluid move together. The method has been applied to a variety of flow problems. Lomholt et al. [6] compared experimental results for the buoyant rise of particles in a vertical channel filled with liquid with results from corresponding simulations with FCM. The particle Reynolds numbers were in the range of 0 to 5 and the results agreed well. The wake-capture and the drafting, kissing and tumbling of pairs of particles, or of a group of three particles were found to match. Comparisons have made too with full direct numerical simulations performed with a spectral element code [7]. Liu et al. [8] examined the motion of particles in a channel at both low and finite Reynolds numbers, up to Re = 10. There was in general good agreement between the FCM results and the DNS for the particle motion, and the flow details were consistent away from the particle surface. There has been extensive work in the past on the sedimentation of particles in a homogeneous suspension, mainly for conditions of Stokes flow. Climent & Maxey [9] have verified that the FCM scheme reproduces many of the standard features found for Stokes suspensions. The results for finite Reynolds numbers illustrate how the structure of the suspension changes as fluid inertia is introduced, in particular limiting the growth in velocity fluctuation levels with system size. Further work has been done by Dance [10] on sedimenting suspensions in bounded containers. Recently we have been studying the dynamics of drag reduction by injecting micro-bubbles into a turbulent channel flow. This has been proven through experiments over the past 30 years to be an effective means for drag reduction but the details of the mechanisms involved have not been determined. Numerical simulations by Xu et al. [11] have shown clear evidence of drag reduction for a range of bubble sizes. A key feature is the need to maintain a concentration of bubbles in the near-wall region. In the talk, the method will be described and example results given. Specific issues relevant to gas-solid flows will be discussed.