FORMULATION AND EVALUATION OF

MUCOADHESIVE BUCCAL FILMS OF

RANITIDINE

A dissertation submitted in partial fulfilment of the requirement for

The award of the degree of

MASTER OF PHARMACY
(PHARMACEUTICS)
ITM UNIVERSITY GWALIOR

By

ASHISH RANJAN
(Roll. No. MPYN1PY21014)

Under the Guidance of

Dr. M. ALAGUSUNDARAM, M.Pharm, Ph.D.,
Professor and Dean

Department of Pharmaceutics
SCHOOL OF PHARMACY
ITM UNIVERSITY GWALIOR
NH-44, BYPASS, TURARI, JHANSI ROAD, GWALIOR - 474001
MADHYA PRADESH, INDIA
 Contents
• ABSTRACT
• INTRODUCTION
• DRUG PROFILE
• AIM & OBJECTIVES
• LITERATURE REVIEW
• FORMULATION OF BUCCAL FILM
• IN-VITRO RELEASE STUDIES
• Result and Discussion
• REFERENCE
 ABSTRACT
The polymers of Hydroxy Propyl Methyl Cellulose 15cps (HPMC) and
Poly Vinyl Pyrrolidone (PVP) were dispersed in ethanol,
dichloromethane, and 30% w/w propylene glycol, which served as a
plasticizer and penetration enhancer, to create the Ranitidine buccal
films. An "O"-shaped ring was placed on a glass surface as the
substrate. Based on their physicochemical properties, such as surface
pH, PMA, PML, swelling percentage, WVT, thickness, weight, folding
endurance, and drug content, the manufactured ranitidine buccal films
were assessed or classified. Studies on in-vitro release were carried out.
Both physicochemical features and in-vitro investigations produced
positive results. As a result, the Ranitidine bio adhesive buccal film
formulations have promise because they offer regulated drug
administration, enhance bioavailability, and reduce the dosage of
Ranitidine, preventing the colonic bacteria from degrading Ranitidine.
 INTRODUCTION

• Amongst the various routes of drug delivery, oral route is perhaps the
most preferred to the patient and the clinician alike. However, peroral
administration of drugs has disadvantages such as hepatic first pass
metabolism and enzymatic degradation within the GI tract, that
prohibit oral administration of certain classes of drugs especially
peptides and proteins. Consequently, other absorptive mucosae are
considered as potential sites for drug administration. Transmucosal
routes of drug delivery (i.e., the mucosal linings of the nasal, rectal,
vaginal, ocular, and oral cavity) offer distinct advantages over peroral
administration for systemic drug delivery These advantages include
possible bypass of first pass effect, avoidance of presystemic
elimination within the GI tract, and, depending on the particular drug,
a better enzymatic flora for drug absorption .
 Drug Profile

RANITIDINE
Ranitidine is a competitive inhibitor of histamine H2-receptors, used as
an antiulcerative agent.
CHEMICAL FORMULA :- C13H22N4O3S
STRUCTURE

CHEMICAL NAME
N[2-[[[5-[(dimethylamino) methyl]-2-furanyl] methyl] thio]ethyl]-N'-
methyl-2-nitro-1,1-ethenediamine.
MOLECULAR WEIGHT
350.87.
DESCRIPTION
Ranitidine is a white to pale yellow, granular substance
that is soluble in water. It has a slightly bitter taste and
sulfur like odor.
SOLUBULITY
Freely soluble in glacial acetic acid and methanol, very
slightly soluble in water, and practically insoluble in
ethanol.
 Aim and Objective

The aim of the present research work is to the formulation and

evaluation of mucoadhesive buccal films of Ranitidine with the
following objectives.
 Ranitidine is a competitive inhibitor of selective histamine H2
receptor antagonist, used as an antiulcerative agent and it is a drug
of choice in the treatment of gastric ulcer and readily absorbed
from gastro intestinal tract.
 The bioavailability of Ranitidine following oral administration is
about 50 % which might be due to colonic degradation by colonic
bacteria22. So with buccal drug delivery the bioavailability may
increases by avoiding the colonic degradation. i.e the
bioavailability of Ranitidine is markedly lower from the human
colon than the upper part of GI tract
 Ranitidine undergoes minimal first pass metabolism. After oral
administration 50% absorbed when compared to an intravenous
injection with mean peak levels occurring 2 to 3 hours. But in case of
buccal film the peak plasma level of drug occur in more than 10 h
and the therapy has to be maintained

 By entrapment of drug in the form of buccal film, the dose could be

minimized. By considering the above mentioned points the
Ranitidine might be right and suitable candidate for the formulation
of mucoadhesive buccal film
 LITERATURE REVIEW
 Ji S et al. (2023) Novel buccal film based on tamarind seed
polysaccharide (TSP) and carboxymethylcellulose (CMC) was developed
for mucosal delivery of soybean peptides. Soybean peptides-chitosan
nanoparticles (SP-CS) were prepared and incorporated into TSP-CMC
film to improve the release behavior of soybean peptides in the oral
cavity. The introduction of SP-CS enhanced the flexibility of TSP-CMC
film and decreased its rigidity
 Ammanage A et al. (2020) the aim of the present study was to enhance
the solubility of piroxicam (BCS class II drug) using co-crystallization
technique and formulate the buccal films of selected co-crystals for
improved therapeutic utilization of drug. Co-crystals of drug with
various co-formers (molar ratio 1:1) were prepared by solvent
evaporation method and were screened for their aqueous solubility and
percent drug content. The formation of co-crystals was confirmed by
FTIR, DSC and XRD. Piroxicam co-crystals loaded buccal films were
prepared and evaluated for in vitro drug release, ex vivo drug permeation
while safety of formulation was determined by histopathological study
 Grilc B et al. (2023) present study was aimed to the development and
characterization of valsartan-containing buccal films with an
introduction to a novel technique of image analysis. Visual inspection
of the film provided a wealth of information that was difficult to
quantify objectively. The obtained images of the films observed under
the microscope were embedded in a convolutional neural network
(CNN). The results were clustered according to their visual quality and
on the basis of data distances
 Ashri LY et al. (2020) objective of the present study was to optimize
and evaluate a buccal mucoadhesive tenoxicam (TNX) local delivery
system for the treatment of chronic periodontitis. Full 32 factorial
design was adopted to evaluate the effect of the concentration of
chitosan and polyvinyl pyrrolidone (PVP) on buccal film
characteristics. The results showed that PVP concentration exerted a
significant synergistic effect on film swelling, while chitosan slightly,
but insignificantly, retarded film swelling
 FORMULATION OF BUCCAL FILM

• The formulation of buccal films carried out by two steps as

fabrication of drug free buccal films and fabrication of Famotidine
buccal films using solvent casting method
 Fabrication of drug free buccal films
• The films were prepared by the method of solvent casting technique
employing ‘O’ shape ring placed on a glass surface as substrate.
• The calculated quantities of polymers Hydroxy Propyl Methyl
Cellulose – 15 cps (HPMC) and Poly Vinyl Pyrrolidone (PVP) were
dispersed in ethanol and dichloromethane. The polymeric solutions
are levigation with 30 % w/w propylene glycol which served the
purpose of plasticizer as well as penetration enhancer. The solution
was mixed occasionally to get semisolid consistency. Then this were
casted ona glass surface employing ‘O’ shape ring having 4.2 cm in
diameter
Fabrication of Ranitidine buccal films
The films were prepared by the method of solvent casting
technique employing ‘O’ shape ring placed on a glass surface as
substrate

 The calculated quantities of polymers Hydroxy Propyl

Methyl Cellulose – 15 cps (HPMC) and Poly Vinyl
Pyrrolidone (PVP) were dispersed in ethanol and
dichloromethane. An accurately weighed 100 mg Ranitidine
was incorporated in polymeric solutions after levigation with
30 % w/w propylene glycol which served the purpose of
plasticizer as well as penetration enhancer. The solution was
mixed occasionally to get semisolid consistency
 IN-VITRO RELEASE STUDIES

 The drug release studies were performed with USP dissolution test
apparatus (Paddle method).
• The USP dissolution apparatus was thermostated at the temperature of
37±2 C and stirred at rate of 50 rpm. Each film was fixed on a glass
slide with the help of cyanoacrylate adhesive so that the drug could be
release only from upper face. Then the slide has immersed in the
vessel containing 500 ml of pH 6.8 phosphate buffer. The aliquots of
1 ml were withdrawn at the time interval of every hour and replaced
with equal volume of dissolution medium.
• the study. The samples were analyzed at 313 nm in a UV
Spectrophotometer and cumulative amount of drug release at various
time intervals was calculated.
 Result and Discussion

• Buccal films of Ranitidine were prepared by the method of solvent casting

technique employing ‘O’ shape ring having diameter of 4.2 cm placed on a
glass surface as substrate with mucoadhesive polymers of HPMC 15 cps and
PVP. Ethanol and Dichloromethane is used as the solvents. Propylene glycol
was used as the plasticizer as well as penetration enhancer. The drug
delivery system was formulated as a matrix controlled drug delivery. The
compositions . The formulated Ranitidine buccal films ,immediately after
formulation, during swelling and on storage The prepared ranitidine buccal
films were evaluated or characterized based upon their physico chemical
characteristics like surface pH, PMA, PML, swelling percentage, WVT,
thickness, weight, folding endurance and drug content. The in vitro drug
release studies were performed by using USP dissolution apparatus (paddle
method) was thermostated at 37±1oc. i.e. the films were fixed with the help
of cyanoacrylate adhesive so that the drug released only from upper face.
The physicochemical evaluation values of prepared buccal films of
Ranitidine is represented
 Conclusion

• The Ranitidine buccal films were prepared by the solvent casting

technique employing an "O"-shaped ring placed on a glass surface as
substrate, using polymers of Hydroxy Propyl Methyl Cellulose -15cps
(HPMC) and Poly Vinyl Pyrrolidone (PVP) dispersed in ethanol,
dichloromethane, and 30 % w/w propylene glycol, which served the
purpose of plasticizer as well as penetration enhancer. The prepared
Ranitidine buccal films were evaluated or characterized based upon their
physicochemical characteristics like surface pH, PMA, PML, swelling
percentage, WVT, thickness, weight, folding endurance, and drug content.
The in-vitro release studies were performed. Good results were obtained
both in physicochemical characteristics and in-vitro studies. Hence, the
formulations of Ranitidine bioadhesive buccal film are promising as they
provide controlled drug delivery, improve bioavailability, and minimize
the dose of Ranitidine, thereby preventing the colonic degradation of
ranitidine by colonic bacteria.
 References

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delivery system. International journal of pharmaceutical sciences and
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 Pather SI, Rathbone MJ, Şenel S. Current status and the future of buccal
drugdelivery systems. Expert Opinion on Drug Delivery. 2008 May
1;5(5):531-42.
 Reddy PC, Chaitanya KS, Rao YM. A review on bioadhesive buccal drug
delivery systems: current status of formulation and evaluation methods.
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 Puratchikody A, Prasanth VV, Mathew ST, Kumar A. Buccal drug
delivery: past, present and future-a review. International Journal of Drug
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