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Buccal drug delivery system

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Buccal drug delivery system

  1. 1. Buccal drug delivery system Saran Kumar das 1st year M.Pharm Department of pharmaceutics Al-Ameen college of pharmacy 10-Nov-18 1
  2. 2. Topics to be cover...  Introduction  Buccal Drug Delivery  Sublingual DrugDelivery  Difference Buccal and Sublingual Drug Delivery  Application of Buccal Drug Delivery  Advantage and Disadvantage  Buccal Dosage Forms  Mucoadhesion  History of Mucoadhesion  Anatomy of Buccal Mucosa  Principle of Mucoadhesion 10-Nov-18 2
  3. 3. Introduction  An ideal dosage regimen in the drug therapy of any disease is the one, which immediately attains the desired therapeutic concentration of drug in plasma (or at the site of action) and maintains it constant for the entire duration of treatment.  Novel drug delivery systems (NDDS) are the system where the man searches for new method of entry of drug into the body in order to show its activity in the body. 10-Nov-18 3
  4. 4.  Classification of Drug delivery in the oral Mucosal Cavity 1. Buccal drug Delivery 2. Sublingual Delivery 3. Local Delivery 10-Nov-18 4
  5. 5.  In oral cavity, buccal region deals with an acceptable route of administration for systemic drug delivery.  Delivery of drug through Buccal mucosa of oral cavity is called Buccal drug delivery system.  Buccal cavity mucosa was the most convenient and also easily approachable site for purpose of delivering the therapeutic agent for both local as well as systemic delivery used as retentive dosage form.  Mucosa has a rich blood supply so it is highly permeable. Buccal Drug Delivery 10-Nov-18 5
  6. 6. Buccal Mucosa  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 vascularised and more accessible for the administration and removal of dosage form. High patient acceptability, extensive first pass metabolism. 10-Nov-18 6
  7. 7. BUCCAL MUCOSA REGION 10-Nov-18 7
  8. 8.  In the sublingual drug delivery where administration of drug via sublingual mucosa to systemic circulation.  Sublingual mucosa is the membrane of ventral surface of tongue and floor of the mouth. Sublingual Drug Delivery 10-Nov-18 8
  10. 10. Buccal vs Sublingual Drug Delivery Buccal Drug Delivery Sublingual Drug Delivery Delivery of drug through Buccal mucosa of oral cavity is called Buccal drug delivery system. Delivery of the drug through Sublingual mucosa of oral cavity is called Sublingual drug delivery system. It is a pharmacological route of administration in which substances diffuse into the blood through tissue of inner cheek. It is a pharmacological route of administration in which substances diffuse into the blood through tissue under the tongue. Mainly use for Psychiatric drug, opioid drug, Cardiovascular Drug , Hormone Replacement Theory. Mainly use for cardiovascular drugs, Steroids, opioid analgesics Low permeability compare to sublingual High permeability compare to buccal Less faster compare to sublingual More faster compare to buccal 10-Nov-18 10
  11. 11. Application Buccal Drug Delivery  Smoking cessation therapy. Eg- Nicotine patches  Hormone replacement therapy.  Hypertension. Eg- Atenolol patches.  Angina pectoris. Eg- Nitro-glycerine tablets / patches.  Cancer. Eg- Opioid Analgesics. 10-Nov-18 11
  12. 12. Advantage of Buccal Drug Delivery  Avoids 1st pass metabolism  Avoids acid/Enzyme metabolism  Permeation is faster with respect to Skin & TDDS (4- 4000)  Large surface area with respect to sub-lingual mucosa  Good patient compliance with respect to parental  Easy administration & removal in case of toxicity.  For unconscious or comatose patients 10-Nov-18 12
  13. 13. Cont...  Easy Access to membrane site so that the delivery system can be applied, localized and remove easily.  High patient acceptance as compared to the other non-oral routes of administration of drugs.  Presence of the saliva helps in dissolution of drug.  Improve performance of many drugs, as they are having prolonged contact time with the mucosa. 10-Nov-18 13
  14. 14. LIMITATION of BUCCAL DRUG DELIVERY  In the buccal membrane there is generally low permeability.  Drugs with bitter taste or irritant to mucosa or having noxious smell  Not for children  Eating & drinking difficulty  Salivary erosion & it may enter GIT & choke esophagus  Less surface area than skin  Drugs unstable at Buccal pH(6.5 to 7) 10-Nov-18 14
  15. 15. Cont...  It has smaller surface area of membrane of the oral cavity 170 cm2 denotes non-keratinised tissue, including the buccal membrane.  The secretion of saliva is continuous (0.5-2 L/day) which cause irritation . 10-Nov-18 15
  16. 16. Buccal Dosage forms  There are various types of buccal dosage forms are available but mainly:- 1. Buccal Tablets 2. Buccal patches/ Films 3. Buccal gel/ Ointment 10-Nov-18 16
  17. 17. Buccal Tablet 10-Nov-18 17
  18. 18. Buccal Patch/Films 10-Nov-18 18
  19. 19. Buccal Gel/ Ointment 10-Nov-18 19
  20. 20. Mucoadhesion  Mucoadhesive are synthetic or natural polymers which interact with the mucus layer covering the mucosal epithelial surface and mucin molecules constituting a major part of mucus.  Two surfaces are held together by interfacial forces which may consist of valence forces, inter locking action or both.  Mucoadhesive drug delivery system utilize the property of bio adhesion of certain water-soluble polymers which become adhesive on hydration.  If adhesive attachment is to a mucous coat the phenomenon is known as mucoadhesion. 10-Nov-18 20
  21. 21. Example of Mucoadhesive Polymer  Natural polymers : Chitosan, Xanthum gum, Pectin and Alginates  Synthetic polymers : 1. Polyacrylic acid derivatives:- Carbopol, Polycarbophil, Polyacrylate 2. Cellulose derivatives :- Carboxy methyl cellulose, HPMC, Methyl cellulose, Methyl hydroxy ethyl cellulose 10-Nov-18 21
  22. 22. History of Mucoadhesion  Since the early 1980,the concept of Mucoadhesion has gained considerable interest in pharmaceutical technology.  MDDS have been developed for buccal ,nasal, rectal & vaginal routes for both systemic & local effects.  MDDS is the best choice for hydrophilic high mol. wt. substance such as peptides that cannot be administered & which has poor absorption. 10-Nov-18 22
  23. 23. YEAR SCIENTIST STUDY 1847 Sobrero Absorptionof drugs via the mucous membranes of the oral cavity 1935/1944 Walton Systemic studies of oral cavity absorption 1955 Kartzand Barr Reviews of the systemicstudies of oral cavityabsorption 1966 Gibaldi 10-Nov-18 23
  24. 24. Anatomy of Buccal Mucosa  Buccal mucosa lines the inner region of cheeks.  It has mainly two parts & is 500-800um thick & 150Cm^2 approx.  The oral mucosa is divided as 1. Epithelium 2. Basement membrane and connective tissues. 10-Nov-18 24
  25. 25. 1. Epithelium • The oral epithelium of the mouth consists of 40-50 layers Stratified & Squamous epithelial cell, having thickness of 500-800 µm, which can be keratinized, or non-keratinized. • Keratinized epithelium is dehydrated, mechanically tough and chemically resistant. It is found in areas of the oral cavity subject to mechanical stress such as the mucosa of the gingiva ( gums ) and hard palate ( roof of mouth ). 10-Nov-18 25
  26. 26. Cont... • Non-keratinized epithelium is relatively flexible and is found in areas such as the soft palate, the floor of the mouth, the lips and the cheeks. • Thus the regions of the oral cavity pertinent to drug delivery (i.e. the sublingual and buccal regions) have a non-keratinized epithelium. 10-Nov-18 26
  27. 27. 2. Basement membrane and connective tissue  The basement membrane is a continuous layer of extracellular materials and form a boundary between the basal layer of epithelium and the connective tissues.  This basal complex anchors the epithelium to the connective tissue and supplements to the barrier functions of the superficial layers of the epithelium to prevent some large molecules from passing the oral mucosa. 10-Nov-18 27
  28. 28. Cont...  The bulk of connective tissue consists of a collagen fibre network, this organization of which determines mechanical stability, resistance to deformation and extendibility of the tissue.  Most likely, the connective tissue, along with the basement membrane, is not consider to influence the diffusion of most compounds of pharmacological interest although this two regions may limit the movement of some macro molecules and complexes. 10-Nov-18 28
  29. 29. STRUCTURE of BUCCAL MUCOSA10-Nov-18 29
  30. 30. Principle of Mucoadhesion  MUCO  Inner layers called mucosa  Inner epithelial Cell lining is Covered with viscoelastic fluid.  Secreted by Goblet cells  Composed of water and mucin (an anionic polyelectrolyte )  Other components include proteins, lipids, mucopolysaccharides, electrolytes.  Thickness varies from ≈40–50 μm to ≈300 μm  Main role is protective and lubricates 10-Nov-18 30
  31. 31.  ADHESIVE  Tendency of substance to remain adhered to surface.  If substance adhere to Biological membrane it is called as Bio adhesion .  If substance adhere to Biological mucosal layers it is called as Mucoadhesion. 10-Nov-18 31
  32. 32. THEORIES OF MUCOADHESION  There are mainly five main theories of mucoadhesion, those are:- 1. Wetting theory . 2. Diffusion theory . 3. Electronic theory . 4. Adsorption theory . 5. Fracture theory . 10-Nov-18 32
  33. 33. Wetting theory  This theory is predominantly applicable to the liquid bioadhesive system and analyses the adhesive and contact behavior in terms of the ability of a liquid or a paste to spread over a biological system.  The wetting theory applies to liquid systems which present affinity to the surface in order to spread over it. 10-Nov-18 33
  34. 34. Cont...  This affinity can be found by using measuring techniques such as the contact angle.  The general rule states that the lower the contact angle, the greater is the affinity.  The wetting theory calculates the contact angle and the thermodynamic work of adhesion. 10-Nov-18 34
  35. 35.  It is best applied to liquid or low-viscosity bioadhesive.  The contact angle should be equal or close to zero to provide adequate spreadability.  If a bioadhesive material is to successfully adhere to a biological surface, it must first dispel barrier substances and then spontaneously spread across the underlying substrate, either tissue or mucus.  The spreadability coefficient can be calculated from the difference between the surface energies γ B and γA and the interfacial energy γAB, as indicated in the equation given below. SAB =γB –γA –γAB 10-Nov-18 35
  36. 36.  This theory explains the importance of contact angle and reduction of surface and interfacial energies to achieve good amount of mucoadhesion. 10-Nov-18 36
  37. 37. Diffusion theory  Diffusion theory describes the interpenetration of both polymer and mucin chains to a sufficient depth to create a semi- permanent adhesive bond.  In bioaddition, the polymer first brought into intimate contact with the mucous, and over a time the concentration gradient across the interface cause the diffusion of the chain of the bioadhesive into the mucous layer.  The rate of diffusion is dependent on the chemical potential gradient and the diffusion coefficient of a macromolecule through cross-linked network. 10-Nov-18 37
  38. 38.  It is believed that adhesion force increase with the degree of penetration of the polymer chain.  In order for diffusion to occur, it is important that the components involved have good mutual solubility, that is, both the bioadhesive and the mucus have similar chemical structures.  The greater the structural similarity, the better is the mucoadhesive bond. 10-Nov-18 38
  39. 39. Electronic theory  Transfer of electrons occurs on contact of an adhesive polymer with a mucus glycoprotein network, because of differences in their electronic structures.  The mutual transfer of electrons results in the formation of electrical double layer at the interface.  Adhesion occurs due to attractive forces across the double layer. 10-Nov-18 39
  40. 40. Adsorption theory  After an initial contact between the two surfaces, the material adheres because of surface forces acting between the atoms in the two surfaces. • Several forces are develop for two types of chemical bonds:- a. Primary chemical bonds of covalent nature, which are undesirable in bioadhesion because their high strength may result in permanent bonds. b. Secondary chemical bonds having many different forces of attraction including electrostatic forces, van-derwals forces , hydrogen bonds and hydrophobic bonds. 10-Nov-18 40
  41. 41. FRACTURE THEORY  This is perhaps the most used theory in studies on the mechanical measurement of mucoadhesion.  It analyzes the force required to separate two surfaces after adhesion is established.  This force, Sm, is frequently calculated in tests of resistant to rupture by the ratio of the maximal detachment force, 𝑭A and the total surface area, Ao, involved in the adhesive interaction 𝑺M = 𝑭A /AO 10-Nov-18 41
  42. 42.  Since the fracture theory is concerned only with the force required to separate the parts, it does not take into account the interpenetration or diffusion of polymer chains.  Consequently, it is appropriate for use in the calculations for rigid or semi- rigid bioadhesive materials, in which the polymer chains do not penetrate into the mucus layer. 10-Nov-18 42
  43. 43. 10-Nov-18 43
  44. 44. Important Questions  What is Buccal Drug Delivery system?  Difference Between Buccal and Sublingual drug Delivery System  Short note on Mucoadhesion  Theories of Mucoadhesion  Advantage and disadvantage of Buccal Drug Delivery System 10-Nov-18 44
  45. 45. 10-Nov-18 45
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