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      Design Optimization and In Vitro- In Vivo Evaluation of Orally Dissolving Strips of Clobazam

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      1 , 2 , 1 , *
      Journal of Drug Delivery
      Hindawi Publishing Corporation

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          Abstract

          Clobazam orally dissolving strips were prepared by solvent casting method. A full 3 2 factorial design was applied for optimization using different concentration of film forming polymer and disintegrating agent as independent variable and disintegration time, % cumulative drug release, and tensile strength as dependent variable. In addition the prepared films were also evaluated for surface pH, folding endurance, and content uniformity. The optimized film formulation showing the maximum in vitro drug release, satisfactory in vitro disintegration time, and tensile strength was selected for bioavailability study and compared with a reference marketed product (frisium5 tablets) in rabbits. Formulation (F6) was selected by the Design-expert software which exhibited DT (24 sec), TS (2.85 N/cm 2), and in vitro drug release (96.6%). Statistical evaluation revealed no significant difference between the bioavailability parameters of the test film (F6) and the reference product. The mean ratio values (test/reference) of C max (95.87%), t max (71.42%), AUC 0− t (98.125%), and AUC 0−∞ (99.213%) indicated that the two formulae exhibited comparable plasma level-time profiles.

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          Most cited references35

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          Interpretation of percent dissolved-time plots derived from in vitro testing of conventional tablets and capsules.

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            On the molecular characteristics, compositional properties, and structural-functional mechanisms of maltodextrins: a review.

            Compositional, physicochemical, and structural properties of maltodextrins and the most important advances that have been made are critically reviewed. Individual topics focuses on the maltodextrin production, carbohydrate composition, and dextrose equivalent determination, factors that alter the polysaccharide properties, the molecular arrangement, the mechanisms and complex physicochemical changes of maltodextrins such as water interaction (hygroscopicity, precipitation, turbidity, bound and free water) and the role of molecular interactions for a network formation. Of particular importance is the information concerning the network structure of maltodextrins gels (degree of crystallinity, crystallite size, aggregation) and the involvement of linear and branched chains for the network formation. Rheological properties have become a desirable tool to predict and understand their structural and functional properties, in single and in mixed systems with other macromolecules. These advances are assessed together with the structural development of food products and processes. Their main food applications, particular advantages, recent commercial directions, and modifications together with potential problems are also discussed. As food ingredients, maltodextrins are a valuable production tool, but still with considerable promises. Nevertheless, a more detailed knowledge of the properties of maltodextrins is necessary in order for their use to be considered as sufficiently effective and desirable in a number of known food applications and for novel development purposes.
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              Fast dissolving films made of maltodextrins.

              This work aimed to study maltodextrins (MDX) with a low dextrose equivalent as film forming material and their application in the design of oral fast-dissolving films. The suitable plasticizer and its concentration were selected on the basis of flexibility, tensile strength and stickiness of MDX films, and the MDX/plasticizer interactions were investigated by ATR-FTIR spectroscopy. Flexible films were obtained by using 16-20% w/w glycerin (GLY). This basic formulation was adapted to the main production technologies, casting and solvent evaporation (Series C) or hot-melt extrusion (Series E), by adding sorbitan monoleate (SO) or cellulose microcrystalline (MCC), respectively. MCC decreased the film ductility and significantly affected the film disintegration time both in vitro and in vivo (Series C<10s; Series E approximately 1min). To assess the film loading capacity, piroxicam (PRX), a water insoluble drug, was selected. The loading of a drug as a powder decreased the film ductility, but the formulation maintained satisfactory flexibility and resistance to elongation for production and packaging procedures. The films present a high loading capacity, up to 25mg for a surface of 6cm(2). The PRX dissolution rate significantly improved in Series C films independently of the PRX/MDX ratio.
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                Author and article information

                Journal
                J Drug Deliv
                J Drug Deliv
                JDD
                Journal of Drug Delivery
                Hindawi Publishing Corporation
                2090-3014
                2090-3022
                2014
                28 September 2014
                : 2014
                : 392783
                Affiliations
                1Chitkara College of Pharmacy, Chandigarh-Patiala National Highway, Rajpura, Patiala, Punjab 140 401, India
                2Crest Healthcare Pvt. Ltd., Baddi, Himachal Pradesh 173205, India
                Author notes

                Academic Editor: Jaleh Varshosaz

                Article
                10.1155/2014/392783
                4195261
                25328709
                66e48066-c42c-440f-9ccb-f9aa7ca74786
                Copyright © 2014 Rajni Bala et al.

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 25 May 2014
                : 3 August 2014
                : 17 August 2014
                Categories
                Research Article

                Pharmaceutical chemistry
                Pharmaceutical chemistry

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