Formulation and optimization of buccal film of Atmoxetine HCl
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Author:
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GORVADIYA D, DHARA C, MALAY C, REENA K, ANJALI S, MINA S, MEGHA G
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Abstract:
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The buccal film dosage form-based approach will provide maximum therapeutic efficacy, increased
bioavailability, and reducing the frequency of dosage. The present research aimed to prepare sublingual films of
Atomoxetine HCl used in the management of deficit/hyperactivity disorder (ADHD) in children, adolescents,
and adults. HPMC E3 LV, SSG and PEG-400 were selected for preparation of buccal Films. The film was
prepared using solvent casting method and employed 32 full factorial experimental design. Disintegration time,
Folding endurance and T90 % were taken as dependent variables. For optimization of the formulation the
statistical design applied and with the help of result of ANOVA, Regression, Contour Plot, and response surface
plots concluded that F7 batch having the desire and it having good response for Disintegration Time 25 sec,
Folding Endurance 193 No., and Drug Release after 360 sec showed 99.01 sec. So, F7 batch consider as
optimized batch it gives fast onset of action and good folding endurance. The Short Term Accelerated Stability
Study was carried out for the Optimized formulation at 40? C and 75% RH and concludes that product is stable
under condition. The taste mask evaluation is carried out by taste panel evaluation for optimized batch and
conclude that taste is masked. It is concluded that the developed formulation can be an advanced dosage form
to improve onset of action and improve patient compliance
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Keyword:
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Atomoxetine HCl, Buccal film, Disintegration time, Folding endurance, Solvent casting method
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EOI:
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-
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DOI:
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https://doi.org/10.31838/ijpr/2021.13.03.109
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