A review on mouth dissolving films.

National Institute of Pharmaceutical Education and Research (NIPER)-Ahmedabad. C/o. B.V. Patel Pharmaceutical Education and Research Development Centre, S.G. Highway, Thaltej, Ahmedabad-380054, India.
Current Drug Delivery 09/2009; 6(5):469-76. DOI: 10.2174/156720109789941713
Source: PubMed

ABSTRACT The ultimate goal of any drug delivery system is the successful delivery of the drug to the body; however, patient compliance must not be overlooked. Fast dissolving drug delivery systems, such as, Mouth Dissolving Films (MDF), offer a convenient way of dosing medications, not only to special population groups with swallowing difficulties such as children and the elderly, but also to the general population. MDF are the novel dosage forms that disintegrate and dissolve within the oral cavity. Intra-oral absorption permits rapid onset of action and helps by-pass first-pass effects, thereby reducing the unit dose required to produce desired therapeutic effect. The present review provides an overview of various polymers that can be employed in the manufacture of MDF and highlights the effect of polymers and plasticizers on various physico-mechanical properties of MDF. It further gives a brief account of formulation of MDF and problems faced during its manufacture.

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    ABSTRACT: In this study, a novel orodispersible film (ODF) containing drug nanoparticles was developed with the goal of transforming drug nanosuspensions into a solid dosage form and enhancing oral bioavailability of drugs with poor water solubility. Nanosuspensions were prepared by high pressure homogenization and then transformed into ODF containing drug nanoparticles by mixing with hydroxypropyl methylcellulose solution containing microcrystalline cellulose, low substituted hydroxypropylcellulose and PEG-400 followed by film casting and drying. Herpetrione, a novel and potent antiviral agent with poor water solubility that extracted from Herpetospermum caudigerum, was chosen as a model drug and studied systematically. The uniformity of dosage units of the preparation was acceptable according to the criteria of Chinese Pharmacopoeia 2010. The ODF was disintegrated in water within 30 s with reconstituted nanosuspensions particle size of 280 ± 11 nm, which was similar to that of drug nanosuspensions, indicating a good redispersibility of the fast dissolving film. Result of X-ray diffraction showed that HPE in the ODF was in the amorphous state. In the in vitro dissolution test, the ODF containing HPE nanoparticles showed an increased dissolution velocity markedly. In the pharmacokinetics study in rats, compared to HPE coarse suspensions, the ODF containing HPE nanoparticles exhibited significant increase in AUC0-24h, Cmax and decrease in Tmax, MRT. The result revealed that the ODF containing drug nanoparticles may provide a potential opportunity in transforming drug nanosuspensions into a solid dosage form as well as enhancing the dissolution rate and oral bioavailability of poorly water-soluble drugs.
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    ABSTRACT: Abstract Orally dissolving films (dissofilms) have gained increasing popularity and attention due to their ease of administration and avoidance of first pass metabolism. Ketotifen fumarate (KF) bioavailability is reported to be only ∼50% due to hepatic first-pass metabolism. Aiming to surmount this drawback and improve patients' compliance, a 3(2) full factorial design was applied to formulate KF Orodispersible films, and to investigate the effects and interactions of the concentrations of the novel film former; Lycoat NG73® and the film modifier; maltodextrin (MDX) on the characteristics of the films prepared using solvent casting technique. The dissofilms were thoroughly evaluated regarding their weight uniformity, content uniformity, moisture uptake, in vivo mouth dissolving time (MDT) and their thermal behavior via differential scanning calorimetry. Statistical analysis revealed the significant influence of Lycoat NG73® concentration on percent elongation, percent KF dissolved after 5 min, and in vivo MDT, while MDX concentration had significant effect only on percent elongation. Further, storage of the optimal selected formula (15% Lycoat NG73 and 0% MDX) at 40 °C/75% relative humidity for 12 weeks caused no significant change in appearance, KF content or drug dissolution profile. Pharmacokinetic study revealed that the orally dissolving films showed significantly higher absorption extent than the reference marketed product, while no significant difference was observed for Cmax.
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    ABSTRACT: Mouth dissolving film becomes a novel approach to oral drug delivery system as it provides convenience and ease of use over other dosage forms such as orally disintegrating tablets buccal tablets and sublingual tablets, so mouth dissolving films are gaining the interest of large number of pharmaceutical industries. Mouth dissolving film was developed on the basis of technology of transdermal patch. Mouth dissolving films are thin solid dosage forms which when placed in the oral cavity; dissolve within few seconds without chewing and intake of water. The oral buccal mucosa being highly vascularized, drugs can absorbed directly and can enter the systemic circulation without undergoing first-pass hepatic metabolism. This advantage can be exploited in preparing products with improved oral bioavailability of molecules that undergo first pass effect. These films offer convenient way of dosing medication to pediatric, geriatric and bedridden patients. The sublingual and buccal delivery of a drug via thin film has the potential to improve the onset of action, lower the dosing and enhance the efficacy and safety profile of medicament. An ideal film should have the properties like pleasant taste, high stability and ease of handling. Present review provides an account of various formulation methods and their evaluation used in film formulations and applications of mouth dissolving film.
    International Journal of Pharma Research & Review. 10/2013; 2(10):41-47.


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May 17, 2014