Oral Strip Research Articles

UTILIZATION RED DRAGON FRUIT PEEL (HYLOCEREUS POLYRHIZUS) ETHANOL EXTRACT IN ORAL THIN FILM STRIP AS A MOUTH FRESHENER

Objective: The aim of this study was to formulate an oral thin film strip (OTFS) contained the red dragon fruit peel (RDFP) ethanol extract (Hylocereus polyrhizus) and evaluate the characteristic, stability and antibacterial activity against Streptococcus mutans (S. mutans). Methods: The film was made using the solvent casting method by adding a variety of concentration ethanol extract of red dragon fruit peel (5%, 10%, and 15%). The films were evaluated in organoleptic test, weight, thickness, pH, disintegration time, folding endurance, stability test and antibacterial activity. Results: The results showed that the film provided a distinctive color, aroma, and taste of the extract. The result of film evaluation had weight between 0.07-0.21 g, thickness between 0.10-0.20 mm, pH between 5.70-5.99, disintegration time between 34.99-49.13 s, and folding endurance between 321.00-812.83 times. The films were stable for 2 mo at a variety storage temperature (4±2 ℃, 28±2 ℃, and 40±2 ℃). The films showed antibacterial activity for 5%, 10% and 15% with the diameter of inhibition 8.5 mm, 10.8 mm, and 12.9 mm, respectively. Conclusion: Ethanol extract of RDFP can be utilized as a mouth freshener film that is stable for 2 mo and has antibacterial activity against S. mutans.

Studies in Solid Solution Formation between Acetaminophen and Povidone and Mouth-dissolving Strip Formulation.

This invention reports the solubilization of Acetaminophen (ACM) within the Povidone (PVP K30) in the solid state for the first time. First-generation solid dispersions (SDs) were attempted with a different ratio of PVP K:30:ACM. SDs prepared were transparent, suggesting a solid solution (SS) formation, which was a serendipitous discovery. A minimum ratio of 1.25:1 PVP K30: ACM was required to form stable SS, suggesting discontinuous SS. A computational complex prediction tool, fourier transform infrared spectroscopy (FTIR), and differential scanning calorimetry (DSC) confirmed the SS formation. The oral strip formulation was developed from the PVP K30: ACM SS using Polyvinyl alcohol as a film-former found to be optimum concerning physicochemical properties, offering rapid drug dissolution and taste masking. The designed strip is suitable for delivering a child's dose (100-150 mg). However, the developed SS can be formulated as tablets, capsules, or oral dissolving tablets to deliver adult doses with improved therapeutic benefits and patient compliance.

Characterization and shelf-life study of functional yoghurt based oral strip in polypropylene–aluminium/LLDPE blister pack

Characterization and shelf-life study of functional yoghurt based oral strip in polypropylene–aluminium/LLDPE blister pack

Preparation and In vitro, Ex vivo Evaluation of Benzidamine Hydrochloride Loaded Fast Dissolving Oral Strip Formulations: Treatment of Oral Mucositis Due to Side Effects of Chemotherapy and Radiotherapy

Background: Rapidly dissolving oral strips have many advantages, especially in pediatric and geriatric use. Benzydamine hydrochloride is an active substance with local analgesic, anesthetic, antimicrobial and non-steroidal anti-inflammatory properties. Objective: The aim of the study was to formulate and characterize orally dispersible benzydamine hydrochloride- loaded fast dissolving oral strips for the sufficient treatment of oral mucositis with high loading capacity as well as high patient compliance considering ease of use. Methods: Oral strips were prepared by solvent casting method with many different polymer combinations and evaluated for different characteristics. In vitro and ex vivo characterizations were performed. Results: In appearance oral strips were smooth and they were also uniform in thickness and weight. The release rates of the active agent from oral strips reached 100% within 25 minutes. The disintegration time was within the range of 15.5 ± 1.2 seconds. Due to ex vivo permeation studies steady-state flux of benzydamine hydrochloride in simulated saliva and pH 6.8 were found to be 27.1 μg cm−2 h−1 ± 1.4 and 26.2 μg cm−2 h−1 ± 1.7, respectively. No significant difference (p˃0.05) in permeability studies was observed using pH 6.8 phosphate buffer compared to simulated saliva. Conclusion: Active agent was successfully loaded into the strips and the targeted system was successfully performed. Benzydamine hydrochloride as oral strips can be a better solution for the efficient treatment of oral mucositis for cancer patients during chemotherapy and radiotherapy stages.

Hydroxypropyl Methylcellulose Orodispersible Film Containing Desloratadine for Geriatric Use: Formulation and Evaluation.

Oral strip is very similar to thin strip of postage stamp in shape, size and thickness. The strip is designed to be placed on the tongue or any oral mucosal tissue which immediately gets wet and hydrated after being in contact with the saliva. Desloratadine is one of the better- known second-generation antihistamines that has been studied for being effective in relieving the allergic nasal and skin symptoms. The aim of this study is to develop desloratadine orodispersible film (ODF) with fast disintegration time and suitable mechanical strength to treat allergic symptoms in geriatric patients in order to increase compliance and convenience. Solvent casting method using hydroxypropyl methylcellulose (HPMC) as the film forming polymer was applied. Polyethylene glycol 400 (PEG 400) and glycerol (Gly) were used as the plasticizers and citric acid (CA) was used as saliva stimulating agent. The resultant films were evaluated for disintegration time, folding endurance, surface pH, weight variation, thickness, surface morphology using scanning electron microscopy, drug content, content uniformity, moisture loss, moisture uptake, and drug-excipient compatibility using DSC and FT-IR. All the selected films started to disintegrate in less than 14 seconds. Selected optimum films exhibited good mechanical properties with a folding endurance value greater than 100. The uniformity in weight, thickness, and drug content in the selected films was obtained. Surface pH was within the normal range (6.4 - 6.8). A smooth surface of the films was obtained and drugexcipient compatibility was proved using DSC and FT-IR. The dissolution test was done for optimum film formulations by simulating the oral cavity physiological conditions using the conventional dissolution test apparatus. More than 87% of the drug was released by the 4th minute. Orodispersible film of desloratadine was successfully prepared by solvent casting method in order to improve the disintegration/dissolution of the drug in oral cavity and hence better patient compliance and effective therapy.

Development of Oral Thin Film Strip Contained Ethanol Extract of Clove Leaves (Syzygium aromaticum (L.) Merr. & Perry)

Halitosis or bad breath can occur due to poor oral hygiene care, dental caries or infections in the oral cavity. The use of mouth fresheners is one of the solution product to overcome the problem. Oral Thin Film Strip (OTFS) is an alternative mouth freshener. The preparation of OTFS was carried out using the solvent casting method. Five film formula were made with varying concentrations of gelatin and HPMC, namely F1 (0:3), F2 (1:3), F3 (1:1), F4 (3:1), and F5 (3:0). Evaluation of the preparation included organoleptic test, weight uniformity, thickness, disintegration time, pH, and folding resistance. Stability testing was carried out for 3 months at 25±2°C and 40±2°C. Antibacterial activity test against Streptococcus mutans (S. mutans) on the preparation was done using disc diffusion method. The OTFS preparation produced gave a homogeneous colour, aroma and taste of the extract. The resulting preparation had weight between 0.345-0.180 grams, thickness between 0.148-0.247 mm, disintegration time of 44-60 seconds, a pH between 6.06-6.33, and a film folding resistance between 339.83-673.67 times. The preparation was stable in storage for 3 months at a temperature of 25±2℃ and 40±2℃. The preparation showed antibacterial activity against S. mutans with zone of inhibition between 8.0-9.1 mm. Clove leaf ethanol extract can be formulated into OTFS preparations with good physical characteristics, stable in 3 months storage and had antibacterial activity against S. mutans so that it has the potential to overcome bad breath.

Oral Thin-films from Design to Delivery: A Pharmaceutical Viewpoint

Stable drug-type tablets and capsules are painful to drink or chew for many pediatric and geriatric patients. Accurate dosing is also an issue for liquid orals (syrup, suspension, emulsion, and so on). Several fast-dissolving drug delivery systems have been designed to address these issues. One of the innovative methods for rapid drug delivery with self-administration without water or chewing is a thin polymer oral drug strip. Strip-forming polymers, plasticizers, active pharmaceutical ingredients, sweetening agents, saliva enhancing agents, flavoring agents, coloring agents, stabilizing and thickening agents are all used to form oral drug strips. The scope of oral thin films is expanded in this article.

A Short Review on “A Novel Approach in Fast Dissolving Film & their Evaluation Studies”

In the case of chronic illnesses, fast-dissolving drug delivery systems were developed as an oral medication administration alternative to traditional dose forms. For masking the taste of unpleasant drugs and enhancing patient compliance, fast-dissolving films are now recommended over traditional tablets and capsules. Fast dissolving films consist of a very thin oral strip that dissolves in less than one minute when placed on the tongue. Customers have responded positively to dissolvable oral thin films in the form of breath strips, which have been on the market for a few years and are used to administer vitamins, vaccines and other medicinal products. In fact, the review goes through the various production methods for film preparation. The current review summarizes the majority of recent patents on fast-dissolving films. A brief analysis of the several factors considered to analyze such films has been carried out. These fast-dissolving films are better to other oral traditional dose forms in terms of delivering drugs and attaining faster therapeutic blood levels in the case of chronic diseases.

Oral probiotic and its delivery carriers to improve oral health: A review.

In recent years, oral probiotics have been researched on their effectiveness in reducing and preventing oral diseases. Oral probiotics could be introduced into the oral cavity to keep the equilibrium of the microbiome. Hence, the delivery carrier for oral probiotics plays an important factor to ensure a high number of oral probiotics were delivered and released into the oral cavity. This review presents a brief overview of oral microbiota and the role of oral probiotics in reducing oral diseases. Moreover, important aspects of the oral probiotic product such as viability, adherence ability, health effects, safety, and delivery site were discussed. Besides that, the importance of utilizing indigenous oral probiotics was also emphasized. Oral probiotics are commonly found in the market in the form of chewing tablets, lozenges, and capsules. Hence, the oral probiotic carriers currently used in the market and research were reviewed. Furthermore, this review introduces new potential oral probiotic delivery carriers such as oral strip, bucco-adhesive gel, and mouthwash. Their effectiveness in delivering oral probiotics for oral health was also explored.

The Clinical Effects of Supplementation with Oral Strip and Soft Gelatin Capsule of Vitamin D in Deficient Patients: a Single-Blinded Clinical Trial

The Clinical Effects of Supplementation with Oral Strip and Soft Gelatin Capsule of Vitamin D in Deficient Patients: a Single-Blinded Clinical Trial

Development of indigenous Streptococcus salivarius TUCC 1253-fermented soy oral strip using Box-Behnken design for oral health

The study was to develop Streptococcus salivarius TUCC 1253-fermented soy oral strip that exhibits antimicrobial activity against oral pathogens. Indigenous S. salivarius TUCC 1253 isolated from healthy human saliva grew well in soy protein isolate after 24 hrs fermentation. Oral strip was developed using hydroxypropyl methylcellulose polymer, propylene glycol plasticizer, S. salivarius TUCC 1253-fermented soy, peppermint flavouring and distilled water. The formulation was successfully optimized which gives characteristics such as low moisture uptake, high percent elongation and high tensile strength. The formulation was successfully optimized with a percentage error of not greater than 4.22%. The optimized S. salivarius TUCC 1253-fermented soy oral strip (20% v/v inoculum) contains more than 108 CFU/g of live cells. The optimized S. salivarius TUCC 1253-fermented soy oral strip was able to inhibit all studied oral pathogens (Enterococcus faecalis, Streptococcus pyogenes and Staphylococcus aureus) in both aerobic and anaerobic conditions. Up to our knowledge, this is the first available oral strips containing indigenous oral probiotic-fermented soy which serve as a new alternative for oral health.

A Review on Oral Strip Technology: A Feasible Technique to Improve Patient Compliance by Oral Route

Oral Strip Technology (OST) is one of the Oral drug delivery systemwhichever the currentyears gaining much attention and this technology is attracting many of the research groups toconcentrate their research onit. Dysphasia is common problem seen in pediatrics and geriatric patient’s population due to administration of monolithic solid dosage forms which are also seen in the case of fast dissolving tablets considering the size of the tablets and this problem is eliminated with introduction of OST. OST is mainly used for buccoadhesive systems in which they are retained in the oral cavity to release drug in controlled manner. This technology has also been used for local action and rapid release products.Strips are ease of handling and administration, transportability, high stability, no special packaging material and/or processing requirements, no requirement of water for application. The advantage of OST over Orally Disintegrating Tablets is that the OST is relatively easy to fabricate whereas ODTs requires complicated and expensive process used to manufacture thus increasing the overall cost of the therapy. This review article enlightens the present and future perspective of OST along with its materials used for formulation, method of preparation, evaluation and benefits.

Formulation and evaluation of fluconazole loaded oral strips for local treatment of oral candidiasis

This study aimed to develop fluconazole loaded buccal mucoadhesive oral strip for local treatment of oral candidiasis. Oral strip was prepared by solvent casting method with different polymer combinations and evaluated for weight, thickness, drug content, tensile strength, swelling behavior, in vitro disintegration time and drug release, ex vivo mucoadhesive performance, stability study, ex vivo drug diffusion and in vitro antifungal activity. Oral strips were smooth and elegant in appearance; were uniform in thickness, weight and drug content. The disintegration time was within the range of 23–28 s. The release rates of fluconazole from oral strips reached ≈96%. The optimum formulation was stable for 6 months. The in vitro antifungal activity studies showed the efficacy of the oral strip against Candida albicans for an extended period. Cytotoxicity was also studied, and no cytotoxic effect was observed at the tested concentration. The developed oral strip can be a promising delivery system in oral candidiasis.

OPTIMIZATION AND EVALUATION OF CHLORPHENIRAMINE MALEATE ORAL STRIP FOR PEDIATRIC USE

Objective: The goal of performing this study is to prepare an oral strip, especially designed for pediatric use that provides fast onset of action with ease of swallowing particularly for young individuals who suffer from difficulty of swallowing, in addition provides maximum therapeutic effectiveness by reducing the first pass effect.Materials and Methods: The oral strip was prepared by solvent casting technique through using different sole polymers (hydroxypropyl methylcellulose [HPMC] 15cp, HPMC 50cp, polyvinyl alcohol, and sodium carboxymethyl cellulose). Maltodextrin (MD) was added as the secondary polymer in different ratios to optimize the release parameters, and disintegration time (DT), three different plasticizers were employed (propylene glycol, dibutyl phthalate, and glycerin) to boost the film forming polymer characteristics.Results: From this study, it is obvious that F10 which composed of HPMC as a main polymer and MD as a secondary polymer in ratio 2:1, respectively, provides adequate physicochemical characteristics, in vivo/in vitro DT (40/36 s), respectively, nevertheless a satisfactory release parameters as (59.9%) released at 2 min and 80% of drug released at 14.8 min.Conclusion: The optimized formula is pretty encouraging to originate an oral strip that provides ease of administration, fast onset of action with wide acceptance for the pediatric population.

ORAL FAST DISSOLVING DRUG DELIVERY SYSTEM: A MODERN APPROACH FOR PATIENT COMPLIANCE

This review represents importance of mouth dissolving films as compared to other oral dosage forms. Fast dissolving oral drug delivery system are solid dosage form which disintegrate or dissolve within seconds when placed in the mouth without need of water or chewing. First developed fast dissolving dosage form in formulation and the rapid disintegrating properties were obtained through a special procedure or formulation modification, hence mouth dissolving film is proved to be better alternative in such cases. This fast dissolving drug delivery system is suited for the drugs which undergo high first pass metabolism and is used for improving bioavailability. Mouth dissolving film consists of thin oral strip; which release active ingredients immediately after uptake into oral cavity. In present investigation, an attempt has been made to develop oral fast dissolving film. Availability of larger surface area that leads to rapid disintegrating and dissolution in the oral cavity.

EFFICACY OF ORAL REFRESHER STRIP CONTAINING FIVE TYPES OF ESSENTIAL OILS ON ORAL MALODOR

Objective: The aim of this study was to determine the efficacy of an oral freshener strip containing five types of essential oils on oral malodor.Methods: This study was a clinical trial using cross-over, randomized-double-blind, and placebo-controlled trial design with 15 male participants. The measured parameters were tongue coating, organoleptic score, and volatile sulfur compounds (VSCs) score.Results: After the essential oil strip dissolved in the oral cavity, there was no significant reduction in tongue coating, but there was significant reduction (p<0.05) in the organoleptic score until 60 minutes after dissolved and VSCs until 30 minutes after dissolved.Conclusion: Essential oil strips are more effective than placebo strips in reducing oral malodor.

Formulation and Evaluation of Flurbiprofen Oral Film

Fast dissolving film can be defined as a dosage form, which when placed in the oral cavity. It will rapidly disintegrate and dissolves to release the medication for oral mucosal absorption or allow for the gastrointestinal absorption to be achieved when swallowed.
 Flurbiprofen is non-steroidal anti-inflammatory agent with antipyretic and analgesic properties and can be used in low doses 8.75 mg as analgesic and anti inflammatory agent in sore throat infection. This study aims to formulate flurbiprofen as oral dissolving films, to improve the effective relief of pain with severe sore throats with little or no adverse effect.
 Nine formulas were prepared using solvent-casting method, and the effect of different formulation variables on the physical and mechanical properties of the prepared films, besides to the drug release behavior was evaluated.
 It was found that, the prepared oral film of flurbiprofen that contains hydroxypropyl methylcellulose alone showed the fastest in- vivo disintegration time (30 sec.) Among other investigated polymers. The drug release rates was also observed
 The prepared formula F1 which contains HPMC in concentration of (54% w/w), PEG 400 (16% w/w) showed the fastest disintegration time 30seconds, Drug release was 77.5% within 2minutes with satisfactory mechanical properties.
 The overall results suggested that the prepared formula of flurbiprofen can be conveniently administered orally in the form of an oral film for sore throat infection. 
 Keyword:Oral strip, fluriprofen, HPMC polymer.

Bioavailability Enhancement of Rizatriptan Benzoate by Oral Disintegrating Strip: In vitro and In vivo Evaluation

Oral disintegrating strips containing rizatriptan benzoate, a selective 5-hydroxy tryptamine receptor agonist with anti migraine property, was developed using polyvinyl alcohol, sodium alginate and hydroxyl propyl methylcellulose as the base materials. The analytical and bioanalytical methods were developed and validated using HPLC (PDA and flouroscence detectors). The dissolution study performed on the strips revealed that all the five formulations, release the drug within eight minutes. Under ICH accelerated stability conditions, strips were stable at 40°C and 75% humidity for eight weeks. Furthermore, pharmacokinetic properties of oral strip were compared with rizatriptan benzoate marketed tablet. Oral disintegrating strip and tablet showed significantly higher bioavailability. Oral strip exhibited better pharmacokinetic parameters than rizatriptan marketed tablet. The Tmax, Cmax, AUC and t1/2 for oral strip were found to be 1.00 h, 64.13±19.46 ng/mL, 352.00±71.57 ng/mL/h and 3.09±1.03 h respectively, whereas, tablet showed 1.5 h, 38.00±13.43 ng/mL, 210.38± 40.37ng/mL/h and 1.66±0.31 h respectively. These findings confirm that the rizatriptan benzoate oral disintegrating strip is potentially a useful tool for an effective treatment of migraine with improved bioavailability, rapid onset of action and with increased patient compliance.

Development and validation of reversed-phase high-performance liquid chromatography method for estimation of rizatriptan benzoate in oral strip formulations.

Aim:A simple, accurate, precise, and reproducible reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of rizatriptan benzoate in oral strip formulations.Methodology:Separation was achieved under optimized chromatographic condition on a Hiper C18 column (250 mm × 4.6 mm, 5 m) using Shimadzu HPLC. The mobile phase consisted of phosphate buffer (20 mM pH adjusted to 3.2 ± 0.005 with ortho phosphoric acid): Methanol in the ratio of 70:30 v/v with isocratic elution at a flow rate of 1 ml/min at ambient temperature was performed. The detection was carried out at 225 nm using photodiode array detector. The method was validated as per Q1A (R2) guidelines and suitability of developed method was ascertained by using optimized oral strip formulation.Results:The retention time of rizatriptan benzoate was found to be 5.17 min, and the calibration curve was linear in the concentration range of 0.20-20 mg/mL (r2= 0.9998). The limit of detection and the limit of quantitation were found to be 0.016 mg/mL and 0.0528 mg/mL, respectively. Method validation parameters were found to be within the specified limits. The percentage drug content of oral strips formulation was found to be 98.96 ± 1.37.Conclusion:The proposed HPLC method may be used efficiently for routine and quality control analysis of rizatriptan benzoate in pharmaceutical formulations.

An Overview on Fast Dissolving Oral Films

Research and developments in oral drug delivery has evolved to changeover of solid dosage forms from conventional solid tablets/capsules to mouth dissolving drug delivery system (MDDS). Intension behind the development of MDDS was to provide the patients with more conventional means of taking their medication. But in MDDS, dissolution of drug in saliva offers the oral transmucosal absorption of the drug to reach to the systemic circulation. Concept of orotransmucosal drug delivery results into various dosage forms which allows orotransmucosal absorption of the drug. Oral strip is the thin film fabricated using hydrophilic polymers that rapidly dissolves beneath the tongue or in buccal cavity and dissolved drug gets absorbed through the oral mucosal surface to reach to the systemic circulation. Here in this review, formulation consideration, manufacturing, physical evaluation of oral films have been discussed.