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1. DESIGN CHARACTERIZATION & EVALUATION
OF xxxxxx BUCCAL PATCHES
by
xxx
M. Pharmacy II Year
Pharmaceutics
HT. NO. 2568-1xxxx
Department of Pharmacy
KGR Institute of Technology And Management
Rampally-Vill,Keesara-Mndl, Medchal-Dist
Under the Guidance of
Dr. V ANJENEYAULU M. Pharm, Ph.D
Associate Professor
1
4. Buccal Drug Delivery System
The buccal mucosa lines the inner cheek and buccal formulation are placed in mouth
between the upper gums and cheek to treat local and systemic conditions
It is richly vascularized and more accessible for the administration and removal of
dosage from.
Additionally ,buccal drug delivery has highly patient acceptability compared to other non-
oral routes of drug administration.
Extensive first pass metabolism and drug degradation in the harsh gastrointestinal
environment can be administering the drug via buccal route.
4
5. Buccal Drug Delivery System
Drug absorption through buccal mucosa is mainly by passive diffusion into lipoidal
membrane.
After absorption ,the drug is transported through facial vein which then drains into the
general circulation via jugular vein, by passing the liver and there by sparing the drug from
first pass metabolism.
Buccal route provides one of the potential routes for typically large, hydrophilic and unstable
proteins, oligonucleotides and polysaccharides as well as conventional small drug molecules.
5
6. Advantages
1. Ease of administration.
2. Termination of therapy is easy.
3. Permits localization of drug to the oral cavity for a prolonged
period of time.
4. Can be administered to unconscious patients.
5. Offers an excellent route, for the systemic delivery of drugs with
high first pass metabolism, thereby offering a greater
bioavailability.
6. A significant reduction in dose can be achieved thereby reducing
dose related side effects.
6
7. Advantages
7. Drugs which are unstable in the acidic environment are destroyed by enzymatic
or alkaline environment of intestine can be administered by this route.
8. Drugs which show poor bioavailability via the oral route can be administered
conveniently.
9. The presence of saliva ensures relatively large amount of water for drug
dissolution unlike in case of rectal and transdermal routes.
10. Systemic absorption is rapid.
11. This route provides an alternative for the administration of various hormones,
narcotic analgesic, steroids, enzymes, cardiovascular agents etc.
12. The buccal mucosa is highly perfused with blood vessels and offers a greater
permeability than the skin.
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8. Disadvantages
Drugs, which irritate the oral mucosa, have a bitter or unpleasant taste,
odour; can not be administered by this route.
Drugs, which are unstable at buccal pH can not be administered by this
route.
Only drugs with small dose requirements can be administered.
Drugs may swallow with saliva and loses the advantages of buccal
route.
Only those drugs, which are absorbed by passive diffusion can be
administered by this route.
Eating and drinking may become restricted.
8
9. Limitations
The mucus is constantly removed from the epithelial surfaces. It will eventually
wash out the dosage form from the site of application.
The mucous turn over rate is different from person to person so fabrication of the
dosage form is difficult.
The adhesion rate of dosage form in the body may not be as per proposed
specification due to disease state, different physiological factors, etc.
The good mucoadhesive polymers that will fulfill all the requirements are less.
Mucoadhesive polymers are poly electrolytes. Slight variation in pH, charge of the
mucus changes mucoadhesion property of polymer significantly.
This type of drug delivery system is not suitable for drugs that causes tissue
irritation
9
11. Buccal Drug Delivery And
Mucoadhesivity
Mucoadhesion of the device is a key element
The term ‘mucoadhesive’ is commonly used for materials
that bind to the mucin layer of a biological membrane.
&
Achieve systemic delivery of drugs include tablets, patches,
tapes, films, Semisolids and powders.
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13. Buccal Patches
Buccal Patch/Film are laminates consisting of an impermeable backing
layer, a drug-containing reservoir layer from which the drug is released
in a controlled manner, and a bioadhesive surface for mucosal
attachment .
Two methods used to prepare adhesive patches include solvent
casting and direct milling .
In the solvent casting method , the intermediate sheet from which
patches are punched is prepared by casting the solution of the drug and
polymer(s) onto a backing layer sheet and subsequently allowing the
solvent(s ) to evaporate.
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14. Buccal Patches
In the direct milling method , formulation constituents are
homogenously mixed and compressed to the desired thickness, and
patches of predetermined size and shape are then cut or punched out.
An impermeable backing layer may also be applied to control the direction
of drug release , prevent drug loss, and minimize deformation and
disintegration of the device during the application period.
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16. Selection of DRUG for BDDS
MW should be less than 1000da
It should be having both nature i.e. hydro-lipophilic type
Should be potent {low dose so that formulation is not bulky
Non-irritant to mucosa
Drugs that degrades in GIT
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18. Literature Review
Namita Prasad et al 2016
The aim of this article is to study the buccal patches. Buccal patch is a nondissolving
thin matrix modified release dosage form composed of one or more polymer films or
layers containing the drug and/or other excipients. Buccal patches have been become
an interesting area of novel drug delivery system as the dosage forms designed for
buccal administration should not cause irritation and should be small and flexible enough
to be accepted by the patient .The study of buccal patches include its introduction, types
of buccal patches, advantages, limitation, potential uses of buccal patches, polymer
used, methods of preparation, evaluation.
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19. Literature Review
Himabindu Peddapalli et al 2017
Mucoadhesive buccal patches were prepared by solvent casting technique using
mucoadhesive polymers. The patches were evaluated for weight variation, thickness,
surface pH, folding endurance, moisture absorption, drug content uniformity, in vitro drug
release, mechanical properties and ex vivo permeation studies. The results of the
optimised buccal patch indicate that the mucoadhesive buccal patches of duloxetine
hydrochloride may be a good choice for improving the bioavailability by bypassing the
extensive first pass metabolism and acid degradation in the stomach. Duloxetine
hydrochloride can be delivered through the buccal route of drug administration through
the buccal patches.
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20. Aim & Objective
To prepare Buccal patches containing Acrivastine drug with different polymers.
Evaluation of prepared Buccal patches for different parameters like.
Folding endurance
Thickness of the patches
Weight variation
Drug content
To prepare and Evaluate Buccal patches containing Acrivastine
20
21. Plan of Work
Selection of Drug
Selection of better Formulation for effective Treatment
Selection of Excipients
Preparation of Different formulations of Buccal Patches
Evaluation
Pre-formulation studies
Literature Review
21
22. Materials
Sl.No Name of the material Category
1 Carbopol 971 Stabilising, Suspending Agents
2 HPMCk100M Polymer Base
3 Carbopol 934 Thickening Agent
4 Methanol Solvent
5 Dichloromethane Co-solvent
6 Propylene glycol Surfactant, Plasticizer
7 Tween-80 Surfactant
22
23. Drug profile - Acrivastine
Molecular formula : C22H24N2O2
Molecular weight : 348.4382
Bioavailability : 0.18±0.09
Half-life : The mean terminal half-life for acrivastine was 1.9 ± 0.3 hours following single
oral doses and increased to 3.5 ± 1.9 hours at steady state.
Protein binding : Acrivastine binding to human plasma proteins was 50 ± 2.0%.
Dose : 8mg
Category : Histamine Antagonists
Solubility : DMSO: >2mg/mL (warmed)
Description : Acrivastine is a triprolidine analog antihistamine indicated for
the treatment of allergies and hay fever.
Melting point : 222° (dec)
23
24. Drug profile - Acrivastine
Pharmacodynamics :
Mechanism of Action : Competitively blocks histamine at H 2 receptor sites; pseudoephedrine:
causes vasoconstriction and subsequent shrinkage of nasal mucous membranes by alpha-adrenergic
stimulation, promoting nasal drainage.
Pharmacokinetic Properties:
Absorption: Acrivastine was absorbed rapidly from the combination capsule following oral
administration and was as bioavailable as a solution of acrivastine.
Distribution : The oral clearance, and apparent volume of distribution were 2.9 ± 0.7 mL/min/kg and
0.46 ± 0.05 L/kg, respectively, following a single oral dose;
Metabolism: Metabolism is reported 1.1 hours.
Elimination: Renal
Adverse Effects : Seizures, Drowsiness, Drowsiness, Dry mouth, Restlessness
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26. References
1. Himabindu Peddapalli, Krishna Mohan Chinnala, Nagaraj Banala Design And In Vitro Characterization Of
Mucoadhesive Buccal Patches Of Duloxetine Hydrochloride Int J Pharm Pharm Sci, Vol 9, Issue 2, 52-59
2. Rahul Shivajirao Solunke1, , Praveen D. Chaudhari Formulation And Evaluation Of Repaglinide Patches For
Transdermal Drug Delivery Int J Pharm Bio Sci 2017 Jan ; 8(1): (P) 211-219
3. Namita Prasad, Satinder Kakar, Ramandeep Singh A Review On Buccal Patches Innoriginal International
Journal of Sciences I Volume 3 I Issue 5 I Sep-Oct 2016 I 4-8
4. Sirisha Mittapally and Zohra Mohd Saleemudin Formulation And Evaluation Of Domperidone Buccal Patches
World Journal of Pharmacy and Pharmaceutical Sciences Vol 5, Issue 12, 2016.
5. Jayasankari Marimutho Nina Varghese , Sandra Kumari Jaganadan , Dhacshina Sudagar Formulation And
Evaluation Of Zidovudine Mucoadhesive Buccal Patches International Journal of Pharmacology and
Pharmaceutical Sciences 2016; Vol: 3, Issue: 4, 30-40
6. V. T. Iswariya, A. Hari Om Prakash Rao, T. Shyamkumar, N. Naresh, M. Suraj, M. Ramesh Yadav Formulation
And Invitro Evaluation Of Buccal Patches Of Bisoprolol Fumarate ejpmr, 2016, 3(5), 446-453
7. Md. Ikram, Neeraj Gilhotra, and Ritu Mehra Gilhotra Formulation and optimization of mucoadhesive buccal
patches of losartan potassium by using response surface methodology Adv Biomed Res. 2015; 4: 239.
8. Pradeep Kumar Koyi and Arshad Bashir Khan Buccal Patches: A Review IJPSR, 2013; Vol. 4(1): 83-89
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