Oral Films Research Articles

Formulation and Evaluation of Mouth Dissolving Film of Imipramine HCL

The main objective of the present study outlines a systematic approach for Design and Evaluation of Fast Dissolving Oral Films of Imipramine HCl to enhance the therapeutic efficacy and provide rapid onset of action in patients suffering from depression Because of patient may have trouble in swallowing a tablet or capsules. Mouth dissolving film is the most advanced oral solid dosage form due to its flexibility and comfort in use. Mouth dissolving films are oral solid dosage form that disintegrate and dissolve within a minute when placed in mouth without taking water or chewing. This dosage form allows the medication to bypass the first pass metabolism so bioavailability of medication may be improved. Fast dissolving Oral film of Imipramine Hydrochloride was formulated by using solvent casting method with different concentrations of HPMC-E3. Film forming property of various grades of HPMC was investigated based on preliminary characteristics of various batches of FDOFs.

Review on Fast Dissolving Oral Film

Review on Fast Dissolving Oral Film

Development and evaluation of novel famotidine-loaded fast dissolving sublingual film using the quality-by-design approach

The present study deals with the development and evaluation of a novel famotidine (FMD) loaded fast-dissolving sublingual film based on quality-by-design approach using a solvent casting technique. Initially, quality target product profile (QTPP) was set to build quality in patient-centric products. The risk assessment and risk management were performed using Ishikawa diagram and failure mode effect analysis (FMEA). A central composite design (CCD) was employed in order to assess the effect of the formulation variables such as HPMC K-15 and PEG-400 on their responses such as content uniformity, folding endurance, and thickness. The developed optimized sublingual film was characterized by Fourier-transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) for its intermolecular interactions. The morphology of the optimized film was studied by scanning electron microscopy (SEM) in which the drug particles appeared spherical. The developed film showed stability for 3 months according to the International Conference on Harmonization (ICH) Q1A (R2) guidelines. A dissolution study showed enhanced dissolution for the optimized sublingual film as compared to the buccal and oral film. The permeation study of the optimized film showed the highest permeation within 30 min. In vivo study using rabbit as model animal exhibited the improved bioavailability of the drug i.e. 2.05 folds. The drug reached systemic circulation within 15 min to improve bioavailability significantly. Thus, the fast dissolving sublingual film containing FMD potentially overcomes the biopharmaceutical challenges and can be a better alternative system for the administration of FMD for the treatment of peptic ulcers.

Overview about Oral Films in Mental Disorders.

Mental disorders are increasing worldwide, and efforts have been developed by multidisciplinary research groups to combine knowledge from different areas such as psychology, neuroscience, medicine, and biotechnology to develop strategies and products to promote the prevention of mental disorders. Excessive antipsychotic consumption is a public health problem, and innovative strategies must be devised. The development of innovative and, if possible, natural products is one of the strategies to combat this public health problem. Oral films are recent delivery systems that have been developed with several advantages that should be applied in this area. This review intends to draw attention to these new dosage forms of drugs and bioactive molecules pertinent to the field of mental health prevention and therapy and to the need for regulatory guidelines to ensure their quality and safety. This is a critical overview about strengths, weaknesses, opportunities, and threats related to oral film implementation in mental disorder treatment.

Oral film technology: a perspective on translational research and clinical studies

Oral film technology: a perspective on translational research and clinical studies

Formulate and Evaluate, Fast Dissolving thin Film of Metoprolol Succinate

Objective: Metoprolol succinate, which is used to treat cardiovascular disorders, is a strong beta-1 adrenoreceptor blocker with cardio-selective effect but is heavily metabolised in the liver during the first pass. Our goal is to minimise hypertension by creating a film of metoprolol succinate that dissolves quickly.
 Methods: Metoprolol succinate films that dissolve in the mouth were made utilising a solvent casting technique. HPMC E5 was used as the film-forming agent, PEG400 was used as the plasticizer, and honey was included as the film-modifying agent in the final formulation. HPMC E15 (X1) and honey (X2) concentrations were used as independent variables, whereas disintegration time (DT), tensile strength (TS), and % cumulative drug release (CDR) were used as dependent variables in a 32-full factorial design. Thickness, folding endurance, tensile strength, disintegration time, and drug release were among the criteria used to assess the manufactured films. Results showed that HPMC E15 and honey both positively impacted DT and TS while negatively impacting CDR.
 Results: The optimum formulation was determined to be the one with a DT of 58.0 ±1.01 seconds, an in vitro drug release of 105.32± 1.55, and a tensile strength of 73.55 ± 1.37 g/cm2.
 Conclusion: Thus, employing a solvent casting method, a fast-dissolving thin film of Metoprolol succinate was created with effective taste masking and prompt in vitro drug release.
 Keywords: Metoprolol succinate, Fast dissolving oral film, HPMC E5, Honey, Solvent casting

A review on orodispersible drug delivery system

The future of drug delivery holds great promise for orally dispersible dose formulations, which make application simple since no water requirement as compared to conventional solid dosage forms which requires significant volumes of fluids for administration. The objective for development of ODF provides a substitute for pills, syrups, and tablets in treating vomiting as well as nausea, particularly in children. On the basis of transdermal patch delivery system, a novel oral films drug delivery has been introduced. Fast dissolving films disintegrates quickly when come in contact with salivary secretion in the oral mucosa and released the drug fast approximately within 3 mins. ODFs are of different types, like sustained or controlled release, oral patches and fast dissolving films. They can be manufactured using a variety of method including solvent and semi solid casting, hot melt and solid dispersion extrusion, spray drying and rolling. Among them solvent casting method is the most employed method. ODFs comprises of active ingredient, polymer, plasticizer and additives like surfactants, sweetening and coloring agents. ODFs preparation requires hydrophilic polymer which provides quick dissolution in the oral cavity. Hydrophilic polymer act as base for ODFs formulation as they impart mouth feel and mechanical properties of the ODFs also dependent of polymer type. Oral thin-film provide fast drug dissolution precise dosage in a portable, safe, and handy manner that doesn't required water or any special equipment. This review article comprises of different methods for ODFs preparations, ODFs ingredients, ODFs benefits and drawbacks and their packaging.

A review on orodispersible drug delivery system

The future of drug delivery holds great promise for orally dispersible dose formulations, which make application simple since no water requirement as compared to conventional solid dosage forms which requires significant volumes of fluids for administration. The objective for development of ODF provides a substitute for pills, syrups, and tablets in treating vomiting as well as nausea, particularly in children. On the basis of transdermal patch delivery system, a novel oral films drug delivery has been introduced. Fast dissolving films disintegrates quickly when come in contact with salivary secretion in the oral mucosa and released the drug fast approximately within 3 mins. ODFs are of different types, like sustained or controlled release, oral patches and fast dissolving films. They can be manufactured using a variety of method including solvent and semi solid casting, hot melt and solid dispersion extrusion, spray drying and rolling. Among them solvent casting method is the most employed method. ODFs comprises of active ingredient, polymer, plasticizer and additives like surfactants, sweetening and coloring agents. ODFs preparation requires hydrophilic polymer which provides quick dissolution in the oral cavity. Hydrophilic polymer act as base for ODFs formulation as they impart mouth feel and mechanical properties of the ODFs also dependent of polymer type. Oral thin-film provide fast drug dissolution precise dosage in a portable, safe, and handy manner that doesn't required water or any special equipment. This review article comprises of different methods for ODFs preparations, ODFs ingredients, ODFs benefits and drawbacks and their packaging.

Mucoadhesive Films of Liquorice and Chlorhexidine Gluconate for Treating Mouth Ulcers

Abstract: Objectives: Mouth ulcer is a rupture or breaks in the oral mucosal membrane and it leads to atrophy and ulcers in the oral cavity. It increases the risk of infections with the Candida species Inherited trauma and aphthous stomatitis, a disorder characterised by the recurrent production of oral ulcers for unknown reasons, are the most common causes of oral ulceration. Study Design: This study aimed to develop two separates buccal mucoadhesive films, using model drug deglycyrrhizinated liquorice and chlorhexidine gluconate. The film was assessed for weight, thickness, pH, folding endurance, swelling index, mucoadhesive force, % moisture content, drug uniformity, in vitro release of drug, anti-microbial effect including anti-inflammatory activity and scanning electron microscopy. The developed formulations we re-evaluated for surface pH, folding endurance, swelling index, mucoadhesive force, and percentage moisture loss. Results and Conclusion: The results showed that the developed oral films were having good anti-inflammatory activity with an anti-microbial effect. Keywords: Deglycyrrhizinated liquorice, Chlorhexidine gluconate, Mucoadhesive buccal films, Anti-inflammatory activity.

Ultrasonic incorporation of cinnamon essential oil into pre-gelatinized cassava starch oral films

The present work aims to produce oral films (OFs) based on pre-gelatinized starch with incorporation of cinnamon essential oil (CEO). For this purpose, the effectiveness of ultrasound in incorporating the CEO into the filmogenic solution was evaluated, in comparison with the use of magnetic stirring. The OFs were characterized in relation to physical properties, disintegration time, surface pH and total phenolic compounds content. In general, all formulations showed film-forming capacity, however, the distribution of the CEO in the polymer matrix was not efficient, regardless of the incorporation method used. The OFs had a disintegration time <32.17 seconds and the surface pH remained close to the oral pH, regardless of the formulation. All formulations produced with the CEO addition can be considered sources of total phenolic compounds, with the highest concentration observed (86.17±2.53 mg 100 g-1 OF) being produced by ultrasound. OFs based on pre-gelatinized starch can be considered an innovative way for the delivery of cinnamon essential oil, as a source of total phenolic compounds.

A Review on Physicochemical Properties of Polymers Used as Filaments in 3D-Printed Tablets.

Three-dimensional (3D) printing technology has presently been explored widely in the field of pharmaceutical research to produce various conventional as well as novel dosage forms such as tablets, capsules, oral films, pellets, subcutaneous implants, scaffolds, and vaginal rings. The use of this innovative method is a good choice for its advanced technologies and the ability to make tailored medicine specifically for individual patient. There are many 3D printing systems that are used to print tablets, implants, and vaginal rings. Among the available systems, the fused deposition modeling (FDM) is widely utilized. The FDM has been regarded as the best choice of printer as it shows high potential in the production of tablets as a unit dose in 3D printing medicine manufacturing. In order to design a 3D-printed tablet or other dosage forms, the physicochemical properties of polymers play a vital role. One should have proper knowledge about the polymer's properties so that one can select appropriate polymers in order to design 3D-printed dosage form. This review highlighted the various physicochemical properties of polymers that are currently used as filaments in 3D printing. In this manuscript, the authors also discussed various systems that are currently adopted in the 3D printing.

A Review on Formulation and Evaluation of Fast Dissolving Oral Film of Ondencetron

Rather than other dosage forms like orally disintegrating tablets, oral fast dissolving films (OFDFs) have recently been brought to the market because of their simplicity and use. As this technology developed over the last several years from the confection and dental care markets in the form of breath strips to become a novel and widely accepted form by consumers, OFDFs are attracting the attention of a significant number of pharmaceutical enterprises. The drug delivery method known as an orally fast dissolving film dissolves or disintegrates when it is placed in the mouth without the need for water in a matter of seconds. In terms of size, shape, and thickness, OFDFs resemble postage stamps a lot. There is a chance that these movies will introduce the substance into your system

Sustainable 3D printing of oral films with tunable characteristics using CMC-based inks from durian rind wastes

With the growing interest in environmentally friendly and personalized medicines, new concept for combining three-dimensional printing (3DP) with natural-based biomaterials derived from agro-food wastes has emerged. This approach provides sustainable solutions for agricultural waste management and potential for developing of novel pharmaceutical products with tunable characteristics. This work demonstrated the feasibility of fabricating personalized theophylline films with four different structures (Full, Grid, Star, and Hilbert) using syringe extrusion 3DP and carboxymethyl cellulose (CMC) derived from durian rind wastes. Our findings suggested that all the CMC-based inks with shear thinning properties capable of being extruded smoothly through a small nozzle could potentially be used to fabricate the films with various complex printing patterns and high structural fidelity. The results also demonstrated that the film characteristics and release profiles could be easily modified by simply changing the slicing parameters (e.g., infill density and printing pattern). Amongst all formulations, Grid film, which was 3D-printed with 40 % infill and a grid pattern, demonstrated a highly porous structure with high total pore volume. The voids between printing layers in Grid film increased theophylline release (up to 90 % in 45 min) through improved wetting and water penetration. All findings in this study provide significant insight into how to modify film characteristics simply by digitally changing the printing pattern in slicer software without creating a new CAD model. This approach could help to simplify the 3DP process so that non-specialist users can easily implement it in community pharmacies or hospital on demand.

Development and Evaluation of Fast Dissolving Oral Films of Mefenamic Acid for the Management of Fever

Abstract: The marketed formulations of Mefenamic Acid (MA) used for the treatment of fever in the paediatric population are reported to have several drawbacks. This study aimed to develop and evaluate the mefenamic acid–loaded oral dispersible films which may be a better alternative than the existing formulations. The solubility of mefenamic acid was enhanced by forming inclusion complexes with β cyclodextrin. The best ratio for the mefenamic acid-β cyclodextrin inclusion complex, 1:0.5 was selected based on the drug content and in vitro drug release. Fourier transform Infrared spectroscopy and scanning electron microscopy analysis was performed on the complex. The oral dispersible films were developed by solvent casting method and evaluated for parameters such as average weight, thickness, pH, folding endurance, percentage moisture uptake and loss, drug content, in vitro disintegration time and drug release. The statistical analysis of the data suggested that oral dispersible films with 4% w/v of crospovidone (coded P3) as the best. Drug content (95.46±0.93%), disintegration time (28.6±2.0 s), cumulative percentage drug release (97.41±0.68% in 180 s), and all other investigated parameters of P3 were well within the acceptable limit. The in vitro dissolution profile of P3 showed no significant difference from the marketed mefenamic acid suspension and has a good stability profile at in-house testing conditions. The data obtained from this investigation revealed that mefenamic acid oral dispersible films could act as an excellent alternative to existing marketed paediatric formulations. Keywords: Oral dispersible films, Mefenamic acid, β Cyclodextrin, Paediatric, Kneading method, Solvent casting.

Review on Fast Dissolving Oral Film

Review on Fast Dissolving Oral Film

Preparation and characterization of fast-release oral film formulation containing ondansetron hydrochloride solid dispersion

Ondansetron has been widely applied as an antiemetic drug in the treatment or prevention of nausea and vomiting caused by emetic cancer chemotherapy . Fast-release films have the advantages of rapid drug release and improved patients’compliance, especially for the disabled bedridden, the elderly or pediatric patients.The basic film-forming materials were studied through single factor tests and the crystal inhibitors were optimized using solid dispersion technique. The ratio of drug and polymers were optimized by X-ray diffraction (XRD) and Differential Scanning Calorimetry (DSC) which revealed there was no presence of crystal in the optimized solid dispersion. The final film was white thin films and was smooth in surface without obvious bubbles or cracks. Mean weight of each film was 40~50mg. Mean thichness was 60~70μm. Surface pH was 6.4~6.6. The films could release 85% of drug with 1.5min in 0.1mol/L HCl and within 30min in pH6.8PBS. Pharmacolinetic experiment of Ondansetron Hydrochloric solution, marketed films Zuplenz® and the preparation were carried out in rats. As a result, the films of Ondansetron Hydrochloric containing ondansetron solid dispersion had the advantages of fast drug release, improved patient compliance, higher bioavalibility compared to oral solution and the marketed films.

Development, optimization, and invitro evaluation of novel fast dissolving oral films (FDOF's) of Uncaria tomentosa extract to treat osteoarthritis

Fast dissolving oral films(FDOF's) are the popular dosage forms when placed in the oral cavity, disintegrate rapidly and dissolve to release the medication for improving oral absorption. Traditionally Uncaria tomentosa plant is used in the treatment of rheumatoid arthritis as Non-steroidal Anti-inflammatory agent along with analgesic properties. The plant extract is reported to be used in low dose as analgesic and anti-inflammatory agent in Rheumatoid Arthritis. No scientific data was reported on Uncaria plant formulation as FDOF's for treating osteoarthritis. This study aims to formulate fast oral dissolving film(FDOFs) Uncaria tomentosa bark extract and evaluate using Invitro studies for osteoarthritis. About 14 formulations were prepared using standard Box Behnken design protocol for optimization using the natural film formers, synthetic polymers, super disintegrants, plasticizers as independent variables with folding endurance and disintegration time as dependent variables by solvent casting method. Further the formulation characteristics including physical and mechanical behavior of films and drug release behavior was evaluated. The 3D countour plots and response curves suing the design expert software were investigated which proved that the optimized oral dissolving films of extract with Pullalan gum, HPMC (polymers), Propylene glycol, PEG 400 (Co-solvents) and Croscarmellose sodium (super Disintegrant) are stable and uniform with formulation characteristics. The drug release rates prove that F5 and F13 formulations showed 99.90% drug release within 30 min following first order kinetics with satisfactory mechanical properties. The study results suggest that the fast dissolving oral films of Uncaria tomentosa extract is novel, attractive and alternative to the available marketed products resulting in improved patient adherence in treatment of osteoarthritis.

Three-Dimensional-Printed Oral Films Based on LCD: Influence Factors of the Film Printability and Received Qualities.

As an oral mucosal drug delivery system, oral films have been of wide concern in recent years because of their advantages such as rapid absorption, being easy to swallow and avoiding the first-pass effect common for mucoadhesive oral films. However, the currently utilized manufacturing approaches including solvent casting have many limitations, such as solvent residue and difficulties in drying, and are not suitable for personalized customization. To solve these problems, the present study utilizes liquid crystal display (LCD), a photopolymerization-based 3D printing technique, to fabricate mucoadhesive films for oral mucosal drug delivery. The designed printing formulation includes PEGDA as the printing resin, TPO as the photoinitiator, tartrazine as the photoabsorber, PEG 300 as the additive and HPMC as the bioadhesive material. The influence of printing formulation and printing parameters on the printing formability of the oral films were elucidated in depth, and the results suggested that PEG 300 in the formulation not only provided the necessary flexibility of the printed oral films, but also improved drug release rate due to its role as pore former in the produced films. The presence of HPMC could greatly improve the adhesiveness of the 3D-printed oral films, but excessive HPMC increased the viscosity of the printing resin solution, which could strongly hinder the photo-crosslinking reaction and reduce printability. Based on the optimized printing formulation and printing parameters, the bilayer oral films containing a backing layer and an adhesive layer were successfully printed with stable dimensions, adequate mechanical properties, strong adhesion ability, desirable drug release and efficient in vivo therapeutic efficacy. All these results indicated that an LCD-based 3D printing technique is a promising alternative to precisely fabricate oral films for personalized medicine.

Enhancement of Solubility and Dissolution Rate Using Tailored Rapidly Dissolving Oral Films Containing Felodipine Solid Dispersion: In Vitro Characterization and Ex Vivo Studies

Enhancement of Solubility and Dissolution Rate Using Tailored Rapidly Dissolving Oral Films Containing Felodipine Solid Dispersion: In Vitro Characterization and Ex Vivo Studies

Formulation and Characterization of Montelukast Sodium Mouth Dissolving Film Using Cress Seed Mucilage

There is a rising interest in the development of orodispersible films (ODFs) as an alternative to fast dissolving tablets which is attributed to their faster dissolution rate, higher durability, and better patient compliance. Owing to its rheological and also various functional properties, many researchers tried to discover some of the pharmaceutical applications of L. sativum in the development of various dosage forms, in addition to its therapeutic studies, such as binding, dissolving, gelling and sustained release dosage form. The fast-dissolving oral film of the Montelukast sodium by using Cress seed mucilage (CSM) and HPMC (15cps) is prepared by solvent casting method. The fast-dissolving oral film evaluated for folding endurance, surface pH, in-vitro disintegration time, drug content and in-vitro drug release. The physical appearance and folding endurance properties were found to be reasonably good and electron microscopy shows that films are clear, colorless with smooth surface.The drug content of all the films was in the range suggesting that drug was uniformly dispersed throughout all films. The present study was an attempt to develop and evaluate an oral fast dissolving drug delivery system using cress seed mucilage as a film former.
 Keywords: Orodispersible film, Montelukast sodium, Cress seed mucilage, HPMC