International Journal of Trend in Scientific Research and Development (IJTSRD)
Volume 4 Issue 1, December 2019 Available Online: www.ijtsrd.com e-ISSN: 2456 – 6470
@ IJTSRD | Unique Paper ID – IJTSRD29702 | Volume – 4 | Issue – 1 | November-December 2019 Page 847
Formulation Development and Evaluation of
Oral Fast Dissolving Films of Metaclopromide HCL
Zeenath Ruhy
Assistant Professor, Department of Pharmaceutics,
Mother Teresa College of Pharmacy, N.F.C Nagar, Ghatkesar, Medchel, Telangana, India
ABSTRACT
Metaclopromide-HCl is an Anti-emetic used to treat nausea, vomiting and to
increase gastric motility. The present work aimed at preparing oral fast
dissolving films of Metaclopromide-HCl with the purpose of developing a
dosage form for a very quick onset of action, which is very convenient for
administration, without the problem of swallowing and using water. Oral fast
dissolving films of Metaclopromide-HCl were prepared using HPMC (E5, E15)
polymers as film forming agents and polyethylene glycol-400 as plasticizer by
solvent casting method. FTIR showed that there is no interaction between
drug and excipients. Dissolution of prepared fast dissolving oral films of
Metaclopromide-HCl was performed using USP type II apparatus in pH 6.8
phosphate buffer medium at 50 rpm with temperature being maintained at
37 0.5º C. The films prepared were evaluated for various parameters like
thickness, drug content uniformity, weight variation, disintegration time,
folding endurance and in vitro drug release and were showed satisfactory
results. In conclusion, development of oral fast dissolving oral films using
HPMC polymer gives rapid drug delivery and rapid onset of action.
KEYWORDS: Oral fast dissolving films, Metaclopromide, HPMC
How to cite this paper: Zeenath Ruhy
"Formulation Development and
Evaluation of Oral Fast Dissolving Films of
Metaclopromide HCL" Published in
International Journal
of Trend in Scientific
Research and
Development (ijtsrd),
ISSN: 2456-6470,
Volume-4 | Issue-1,
December 2019,
pp.847-852, URL:
www.ijtsrd.com/papers/ijtsrd29702.pdf
Copyright © 2019 by author(s) and
International Journal of Trend in Scientific
Research and Development Journal. This
is an Open Access article distributed
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License (CC BY 4.0)
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/4.0)
INRODUCTION
One of the most crucial routes of administrating a drug with
high credit to obtain a systemic effect is the oral
administration for its simplicity, comfortability by producing
no pain compared with the systemic administration and
other remarkable benefits over the other routes[1].
However, it also comes with disadvantages in case of certain
dosage forms as capsules and tablets, as problems of
swallowing especially for children and infants and for elders
leading to incompliance and disadherence to the treatment
[2]. This was proved by evidence that approximately 35% of
the population showed dysphasia and troubles with
swallowing as an example, people with sea/ motion sickness,
hiccups, gagging and obstruction of the esophagus pathway
will be force to search for other alternatives which favor the
systemic drug delivery such as fast dissolving medication [3].
Oral fast-dissolving film is new drug delivery system
developed on the basis of the Transdermal patch [4]. It
consists of a very thin oral strip, which is simply placed on
the tongue or oral mucosal tissue, instantly wet by saliva; the
film rapidly hydrates and adheres onto site for rapid
disintegration and release [5].The objective of the present
study was to develop Oral fast dissolving films (OFDFs) of
Metaclopromide- HCl as Anti-emetic and to provide a
convenient means of administration to those patients
suffering from nausea and vomiting and to increase
gastrointestinal motility.
MATERIALS AND METHODS
Metaclopromide- HCl was obtained as a gift sample from
Aurobindo Ltd., HPMC E5, E15 was used as polymers, PEG
400, Ascorbic acid, and Aspartame is obtained from SD Fine
Chemicals.
Formulation of Metaclopromide-HCl oral fast dissolving
films
The procedure of making of Metaclopromide HCl ODF
All materials were weighed. Some polymers are dissolved in
distilled water. Then left in for 10 minutes to swell. Drug is
dissolved in distilled water, then added aspartame and
ascorbic acid. The solution was stirred until all the material
is completely dissolved. Drug substance solution is added to
the base polymer. PEG 400 was added to the polymer
solution while stirring. The solution was left in at room
temperature to remove air bubbles. After the air bubbles
disappear, the solution was poured into a mold 9 cm x 10 cm
until blended. Film dried at 40°C in the drying cabinet for 24
hours. After drying, the film removed from the mold
carefully and cut the size of 2 cm x 3 cm [6]. The components
of the formulation were shown in Table 1.
IJTSRD29702