FORMULATION

CONSIDERATION OF
BUCCAL DELIVERY SYSTEM
Presented By:
Diwya Kumar Lal
7th Sem/B. Pharmacy
 CONTENTS
• INTRODUCTION
• BASIC COMPONENTS
• FORMULATION CONSIDERATIONS
• ADVANTAGES OF BDDS
• LIMITATION OF BDDS
 INTRODUCTION
• Buccal drug delivery was introduced by Orabase in 1947, when gum
tragacanth was mixed with dental adhesive powder to supply penicillin to
the oral mucosa.
• Buccal delivery is defined as drug administration through the mucosal
membranes lining the cheeks (buccal mucosa).
• Difficulties associated with parenteral delivery and poor oral availability
promoted the impetus for exploring alternative routes for the delivery of
such drugs.
• Among the various transmucosal routes, buccal mucosa has an excellent
accessibility, an expanse of smooth muscle and relatively immobile mucosa,
hence suitable for administration of controlled release dosage forms.
 INTRODUCTION
• Buccal drug delivery has a high patient acceptability compared to other non-
oral transmucosal routes of drug administration.
• Direct access to the systemic circulation through the internal jugular vein
avoids acid hydrolysis in the gastrointestinal (GI) tract and bypasses drugs
from the hepatic first pass metabolism leading to high bioavailability.
 BASIC COMPONENTS
The 4 basic components of buccal drug delivery system are
1. DRUG SUBSTANCE
• The selection of suitable drug for the design of buccoadhesive drug delivery
systems should be based on pharmacokinetic properties
• The drugs having biological half-life between 2-8 hrs are good candidates
for controlled drug delivery.
2. BIOADHESIVE POLYMER
Bio adhesive polymers which adhere to the mucin/ epithelial surface are
effective and lead to significant improvement in the oral drug deliver
It must have high molecular weight and narrow distribution.
Eg. Agarose, chitosan, CMC
 BASIC COMPONENTS
3. BACKING MEMBRANE:
Backing membrane plays a major role in the attachment of bioadhesive devices to the
mucus membrane.
Such impermeable membrane on buccal bioadhesive patches prevents the drug loss and
offers better patient compliance.
Eg. Carbopol, magnesium stearate, HPMC
4. PERMEATION ENHANCERS:
Substances that facilitate the permeation through buccal mucosa are referred as
permeation enhancers.
Mechanisms of action of permeation:
1) Changing mucus rheology
2) Increasing the fluidity of lipid bilayer membrane:
3) Acting on the components at tight junctions
 FORMULATION CONSIDERATIONS
The general considerations in buccal dosage form design includes
1. PHARMACEUTICAL CONSIDERATIONS
The physicochemical characteristics, morphological characters of the drug all
influence the desirable drug release and absorption. In case of dosage forms, for
enhancing the effectiveness and acceptability, some excipients are incorporated.
The absorption of weakly water soluble drugs can be increased by solubilizing
the drug in Cyclodextrin and administered via buccal route.
2. PHYSIOLOGICAL CONSIDERATIONS
Challenges of drug delivery to the oral cavity are Constant flow of saliva and
mobility of tissues
The device size is 1-3 cm and daily dose of 25 mg in case of buccal delivery and
ellipsoid shape favors.
 FORMULATION CONSIDERATIONS

3. PATHOLOGICAL CONSIDERATIONS
Thickness of epithelium is affected mainly with many diseases in which the
barrier of mucosa results in alteration.

4. PHARMACOLOGICAL ASPECTS
In case of systemic circulation buccal dosage form is designed and in local
therapy of oral mucosa. The dosage form is affected mainly due to drug
characteristics, target site of action and at the treated site.
 ADVANTAGES
• Drug release for prolonged period of time.
• In unconscious and trauma patient’s drug can be administered.
• Drugs bypass first pass metabolism so increases bioavailability.
• Some drugs that are unstable in acidic environment of stomach can be
administered by buccal delivery.
• Drug absorption by the passive diffusion.
• Flexibility in physical state, shape, size and surface.
• Maximized absorption rate due to close contact with the absorbing membrane.
• Rapid onset of action.
 LIMITATION

• Drugs which are unstable at buccal pH cannot be administered.

• Drugs which have a bitter taste or unpleasant taste or an obnoxious odor or
irritate the mucosa cannot be administered by this route.
• Drug required with small dose can only be administered.
• Those drugs which are absorbed by passive diffusion can only be
administered by this route.
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