FORMULATION DEVELOPMENT AND CHARACTERIZATION OF

AMISULPRIDE ORAL FAST DISSOLVING FILMS

MADAMANCHI BHANVANI, KONDAMUDI MOUNIKA, NARASAPURAPU SUSHNAVI,

NELAPATI SAILAJA, MUDAVATH HANUMA NAIK, GANGURI SUDHAKARA RAO

VISHWA BHARATHI COLLEGE OF PHARMACEUTICAL SCIENCES,

PERECHERLA, GUNTUR, A.P-522009
Abstract
Oral fast-dissolving film is a new concept for oral delivery of drugs. When it is placed on the
tongue or oral mucosa tissue, it gets instantly wet by saliva, the film rapidly hydrates and adheres
onto the site of application. It then rapidly disintegrates and dissolves to release the active
pharmaceutical ingredient. Schizophrenia is a mental disorder or group of disorders characterized
by disturbances in the form and content of thought, in sense of self and relationship to the
external world and in behavior. Amisulpride is an atypical antipsychotic agent used in the
treatment of psychoses, more particularly in the treatment of paranoid and productive
schizophrenias or acute delirious psychoses. In Present studies, Amisulpride solid dispersions
were formulated into mouth dissolving films. Formulated films show less disintegration and
dissolution time. Presence of super disintegrants decreases disintegration and dissolution time
and provide rapid release of drug. Sodium starch glycolate with plasticizers and film former
showed rapid disintegration and dissolution than croscarmellose sodium. Formulated films
showed almost complete drug release in less than 15 minutes. Release kinetic study of all
formulations follows first order kinetics, which indicates that MDFs obeys rapid dissolution due
to diffusion or self-erosion of polymer matrix. Stability studies revealed that Sodium starch films
was found to be stable at 30°C and 40°C with respect to physical, chemical and % drug release.

Keywords: Amisulpride, Sodium Starch Glycolate, Super Disentegrants, oral-fast dissolving

films.
 SUMMARY

Introduction
Fast dissolving oral films have persistent to extend in sales and launched as patient
compliant and convenient products effectively addressing issues for pharmaceuticals as well
as nutraceuticals that have been traditionally administered as oral solid dosages. The
delivery system consists of a very thin oral strip, which is simply placed on the
patient’s tongue or any oral mucosal tissue, instantly wet by saliva the film rapidly
hydrates and adheres onto the site of application. It then rapidly disintegrates in a
matter of seconds and dissolves to release medication for oromucosal absorption.
Today, fast dissolving oral films are a well proven and worldwide accepted technology
for the systemic delivery of active pharmaceutical ingredients (APIs).
Amisulpride is a benzamide analogue. The chem-ical name of Amisulpride is 4-Amino-N-
[[(2RS)-1-thylpyrrolidin-2-yl]methyl]-5-(ethylsulpho-nyl)-2-methoxybenzamide. It blocks
cerebral dopamine D2 and D3 receptors. When administered at an oral daily dose of 50 mg, it
improves the dopaminergic neurotransmission with a D2 dopaminergic receptors pre-synaptic
inhibition and it is used in the treatment of schizophrenia.
Fast dissolving films of Amisulpride was prepared by solvent casting technique. The fast
dissolving films were prepared using polymers gelatin, HPMC and maltodextrin. Propylene
glycol is used as plasticizer. The calculated amount of polymer was dispersed in three forth
volume with continuous stirring using magnetic stirrer and the final volume was adjusted with
distilled water. The calculated amount of Amisulpride was incorporated in the polymeric
solutions after levigation with required volume of propylene glycol. The solution was casted on
to petri plate then kept in hot air oven at 60 0 C.
All formulations appear as elegant transparent to opaque films with good tensile strength, percent
elongation, folding endurance, weight variation and thickness test of all the formulations show
satisfactory results. Tensile strength, % elongation test and folding endurance test revealed that
formulated films have improved mechanical properties. Drug content of films revealed that drug
was uniformly distributed in polymer matrices with good reproducibility.
Presence of super disintegrants decreases disintegration and dissolution time and provide rapid
release of drug. Sodium starch glycolate with plasticizers and film former showed rapid
disintegration and dissolution than croscarmellose sodium. Formulated films showed almost
complete drug release in less than 15 minutes. Release kinetic study of all formulations follows
first order kinetics, which indicates that MDFs obeys rapid dissolution due to diffusion or self-
erosion of polymer matrix.

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