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Film forming polymers Plasticizers Die swell phenomenon Quality by design Scale up a b s t r a c t Over the recent few decades, many groups of formulation scientists are concentrating on rapid release dosage forms in oral cavity. Among all fast release dosage forms, orodispersible films are successful to attract pharmaceutical industry due to ease of formulation and extension patent life. Films are popular in patients too because of quick onset and user friendliness of dosage form. From the beginning, solvent casting has been selected as method of choice for manufacturing of orodispersible films. Solvent casting has been proved as a benchmark technology because of ease in product development, process optimization, process validation and technology transfer to production scale despite of some drawbacks like more number of unit operations involved and consumption of large quantity of solvents with controlled limits of organic volatile impurities in final formulation. The application ofhot-melt extrusion (HME) in the pharmaceutical industry is consecutively increasing due to its proven innumerable advantages like solvent free continuous process with fewer unit operations and better content uniformity. Very few development activities has been initiated in the field of hot melt extruded orodispersible films so far. This extensive review covers detailed discussion of heavy duty industrial extruders, selection of downstream equipments, selection of excipients, common problems found in formulations and their remedies. Successive part of review addresses identification of critical quality attributes, quality target profile of product, criticality in selection of process parameters and material for substantial simulation in laboratory scale and production for successful technology transfer.

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The real challenge in the development of a controlled drug delivery system is not just to sustain the drug release but also to prolong the presence of the dosage form in the stomach or the upper small intestine until all the drug is completely released in the desired period of time (1-2). The residence of a drug delivery system in the upper part of the gastrointestinal tract (GIT) can be accomplished by several drug delivery systems, such as intragastric floating systems (3), swelling and expandable systems (4), bioadhesive systems (5), modified shape systems (6), high density systems (7), delayed gastric emptying systems (8) and low density super porous systems (9).Domperidone is a synthetic benzimidazole compound that acts as a dopamine D2 receptor antagonist. Domperidone is also used as a prokinetic agent for treatment of up- The purpose of the present study was to develop an optimized gastric floating drug delivery system (GFDDS) containing domperidone as a model drug. Box-Behnken design was employed in formulating the GFDDS with three polymers: hydroxypropyl methylcellulose K4M (HPMC K4M) (X 1 ), Carbopol 934P (X 2 ) and sodium alginate (X 3 ), as independent variables. Floating lag time (FLT), total floating time (TFT), time required to release 50% of the drug (t 50 ) and diffusion exponent (n) were selected as dependent variables. Seventeen formulations were prepared, dissolution data obtained was fitted to the power law and floating profiles were analyzed. HPMC loading was found to be significant for floating properties. Carbopol loading had a negative effect on floating properties but was found helpful in controlling the release rate of the drug. No significant effect of sodium alginate on floating properties was observed but it was important for gel formation. The quadratic mathematical model developed could be used to predict formulations with desired release and floating properties.

The purpose of this research was to develop and optimize a controlled-release multiunit floating system of a highly water soluble drug, ranitidine HCl, using Compritol, Gelucire 50/13, and Gelucire 43/01 as lipid carriers. Ranitidine HCllipid granules were prepared by the melt granulation technique and evaluated for in vitro floating and drug release. Ethyl cellulose, methylcellulose, and hydroxypropyl methylcellulose were evaluated as release rate modifiers. A 3 2 full factorial design was used for optimization by taking the amounts of Gelucire 43/01 (X 1 ) and ethyl cellulose (X 2 ) as independent variables, and the percentage drug released in 1(Q 1 ), 5(Q 5 ), and 10 (Q 10 ) hours as dependent variables. The results revealed that the moderate amount of Gelucire 43/01 and ethyl cellulose provides desired release of ranitidine hydrochloride from a floating system. Batch F4 was considered optimum since it contained less Gelucire and was more similar to the theoretically predicted dissolution profile (f 2 = 62.43). The temperature sensitivity studies for the prepared formulations at 40°C/75% relative humidity for 3 months showed no significant change in in vitro drug release pattern. These studies indicate that the hydrophobic lipid Gelucire 43/01 can be considered an effective carrier for design of a multiunit floating drug delivery system for highly water soluble drugs such as ranitidine HCl.