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 of
hot-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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