This document provides an overview of buccal films as a novel drug delivery system. It discusses the advantages of buccal administration such as rapid drug absorption and avoidance of first-pass metabolism. The document covers various aspects of buccal film formulation such as excipients, drug candidates, manufacturing methods, and evaluation tests. It presents examples of recent research on buccal films and concludes that this dosage form is well-suited for delivering drugs to patients across all age groups.

1. A CRITICAL REVIEW ON BUCCAL FILMS A NOVEL
FORMULATION OF WIDE SPECTRUM DRUGS
Presented by
VINY DAVE
M.Pharm IIIrd semester
Department of Pharmacy
Barkatullah University
at
Sagar Institute of Technology, Bhopal
Guided By
Prof. A.K.Pathak
Prof. Aswani Mishra

2. INDEX
 Introduction
 Need for buccal adminstration
 Limitation
 Classification of buccal systems
 Formulation consideration
 Active pharmaceutical ingredients
 Methods of manufacturing of buccal film
 Evaluation of buccal films

3. INTRODUCTION
Buccal administration refers to a topical route of
administration by which drugs held or applied in the
buccal area (in the cheek) diffuse through the oral
mucosa (tissues which line the mouth) and enter directly
into the bloodstream. Buccal administration may provide
better bioavailability of some drugs and a more
rapid onset of action as compared to oral administration
because the medication does not pass through
the digestive system and thereby avoids first pass
metabolism.

4. NEED FOR BUCCAL ADMINISTREATION
Drug administration via the buccoadhesive drug
delivery offers several advantages such as:
 Improved clinical effect which are demonstrated for
pain killers or local anaesthetics.
 Certain pathologies requires instant release as well
as rapid clinical effect by individual as in case of
migraine.
 In case of sore, throat, cough, allergy and other local
oral manifestations region-specific delivery of
medicament is required.

5.  This dosage form can also be used for natural
extracts and neutraceuticals including vitamin B12,
chromium picolinate melatonin and possibly CoQ10.
 As oral cavity rich in blood supply the drugs
absorption from buccal cavity is relatively fast.
 Due to its good accessibility for membranes which
makes application painless and comfort.
 Patients can control the period of administration or
terminate delivery in case of emergencies..
 Drug can be administered in case of
unconsciousness and trauma patient
 Drug’s bioavailability is increased as it bypass the
metabolism.
 Drugs which are unstable in acidic environment of
stomach can be administered by this delivery.

6. LIMITATIOJN
 Drugs which are unstable at buccal pH.cannot
be administered
 Drugs cannot be formulated for buccal cavity
which will cause allergic reactions, discoloration
of teeth or contain antimicrobial agents which
affects desired natural microbes..
 As compared to sublingual membrane buccal
membrane has low permeability.
 Drugs which have bitter taste or unpleasant
taste or an obnoxious odor or irritate the
mucosa are not applicable for this route

7. FORMULATION CONSIDERATIONS:
Formulation is decided by keeping in mind various
parameter such as performance characteristics
such as taste masking, fast dissolving, physical
appearance, mouth feel etc. Fast dissolving film is
a thin film incorporate with an active ingredient.

8. Sr no. NAME OF EXCIPIENT QUANTITY in %
1 Drug 5-30
2 Film forming agent 40-50
3 Plasticizers 0-20
4 Saliva stimulating agent 2-6
5 Sweetning agent Q.S
6 Surfactant Q.S
7 Flavouring agent Q.S
8 Colouring agent Q.S

9. CLASSIFICATION OF BUCCAL SYSTEMS
 Buccal tablets
 Buccal semisolid dosage forms
 Buccal films
 Buccal powders
 Micro particle

10. CHARACTERSTICS OF DRUG REQUIRED
The drug should have following characteristics .
 The conventional single dose of the drug should be small.
 The drugs having biological half-life between 2-8 hrs are
good candidates for controlled drug delivery.
 Tmax of the drug shows wider-fluctuations or higher values
when given orally.
 Through oral route drug may exhibit first pass effect or
presystemic drug elimination.
 The drug absorption should be passive when given orally.

11. ACTIVE PHARMACEUTICAL AGENTS
From any class of drugs, active substance
can be used for administration but it must be
compatible to the buccal environment. Drug
can be added from 5%-25%w/w of total
weight of polymer. Dose of drug in mg(less
than 20mg/day) is required for effective
formulation.

12. FORMULATION RELATED FACTORS
 Molecular Size
 Partition coefficient
 pH value
 pKa value

13. CLASS OF DRUG USED IN BUCCAL FILM
Several class of drugs can be formulated as
mouth dissolving films including paediatrics
(anti-tussive, expectorants,anti–asthmatics),
geriatrics,antiepileptic,expectorants),
gastrointestinal diseases, nausea (e.g. due to
cytostatic therapy), pain (e.g. migraine), CNS
(ex. Anti Parkinsonism therapy).Depending on
their compatibilty with the formulation and
different physiochemical properties of Drug .

14. Anti-emetics Ondansetron, Granisetron, Plonosetron,
Dronabinol, Aprepitant, Ramosetron,
Trimethobezamide, Nabilone,
Metoclopramide, Dolasetron, Dimenhydramine
Serotonin
inhibitors
Fluoxetine, Setraline, Paroxetine, Fluxoamine,
Citalopram and Alaproclate,
5HT3
antagonists
Alosetron, Ondansetron, Granisetron,
Palonosetron, Rmosetron and Tropisetron
Anti-epileptics Carbamezapine, Clonazepalm, Diazepam,
Divalproex sodium, Fosphenyloin, Gabapentin,
Lamotrigine, Levetiracetam, Oxacarbazepine,
Phenytoin, Primidone and Valproate sodium
Anti-migraines Almotriptan, Dihydrogotamine Mesylate,
Eletriptan, Frovatriptan, Naratriptan,Rizatriptan,
Sumatriptan and Zolmitriptan

15. Dopamine
D1 and D2
antagonists
A misulpride, Bromperidol, Cabergoline,
Domeperidone, Fenoldopam, Halopiridol,
Metoclopramide, Metopimazine, PergolideMesylate,
Prochlorperazine, Quetiapine, Ropinirole
Hydrochloride, Sulpiride, Tiapride, and Zotepine
Statins Atorvastatin, Cerivastatin, Fluvastatin, Lovastatin,
Pitavastatin, Pravastatin, Rosuvastatin and
Simvastatin

16. FEW RECENT RESEARCH DONE IN
BUCOADHESIVE DOSAGE FORM
Drug Polymer Dosage form
Transforming growth
factor-b (TGF-b)
Chitosan-H Gel
Ibuprofen PVP Carboxymethylcellulose sodium salt
(NaCMC)
Patch
Nystatin Carbomer Hydroxypropylmethylcellulose Double-Layered
tablet
Propranolol Ethyl cellulose, polyvinyl pyrolidone K-30,
hydroxypropyl methyl cellulose-15cps,
hydroxyl ethyl cellulose-10cps
Film
Clotrimazole Carbopol-934P Hydroxypropyl cellulose-M Film
Miconazole nitrate Hydroxypropylmethylcellulose, Sodium
carboxymethylcellulose, Carbopol 934P,
and sodium alginate.
Slow-Release
Tablets
Benzocaine Sodium carboxymethylcellulose, Xanthan
gum
Liquid gel, Ointment

17. METHODS OF MANUFACTURE OF FILMS
 Solvent casting
 Greater uniformity of thickness and much
clarity than extrusion.
 Film has fine gloss and freedom from defects
such as die lines.
 More flexibility and better physical Properties
Finished film in thickness is typically 12-100
μm

18. Hot-melt extrusion
Better method for poorly soluble drugs
Lower processing steps
More uniform dispersion because of intense
mixing and agitation
Less energy compared with high shear
methods.

19. EVALUATIONS OF BUCCAL PATCH:
 Surface pH
 Thickness measurements
 Swelling study.
 Folding endurance
 Water absorption capacity test
 Ex-vivo bioadhesion test
 In vitro drug release
 Permeation study of buccal patch
 Ex-vivo mucoadhesion time:-
 Measurement of mechanical properties:-
 Stability study in human saliva

20. CONCLUSION
Pharmaceutical industries have recognized the
potential for delivering medicinal products
through buccal film and have launched several
products for various kind of drugs in the market
using this technology. Recently buccal films
have gained popularity as dosage forms.
Gaining importance as they are ideal dosage
form for use in every categories of patient
whether young children, as well as geriatric
patients. Also, many industries have pipelines of
molecules of shifting their existing tablets
preparation to oral strips.

21. REFERENCE
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