Nasal drug delivery system

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Nasal drug delivery system

  1. 1. 1 RESPIRATORY DRUG DELIVERY SYSTEM BY SUNILBOREDDY
  2. 2. Novel Drug Delivery System Nasal Drug Delivery System Medical aspects Formulation Development Applications Conclusion CONTENTS 2
  3. 3. Novel drug delivery is one of the fastest growing healthcare sectors, with sales of drugs incorporating novel drug delivery systems increasing @ an annual rate of 15% 3
  4. 4. By 2010, the US drug delivery market alone will be worth $30 billion 4
  5. 5. Why Novel Drug Delivery system? To optimize drug’s therapeutic effect, convenience and dose To enhance a product’s life-cycle To improve `patient compliance To target drug delivery To control overall healthcare costs To facilitate biological drug delivery 5
  6. 6. Drug Delivery Systems Oral Inject- able Mucosal Trans- dermal Ocular Vaginal/ Anal Needle Needle- less Nasal Buccal Pulmo- nary Active Passive Topical 6
  7. 7. Global drug delivery market by administration mode Oral 53% Inhalation 32% Transdermal 8% Injectable/ Implant 3% Ocular 2% Nasal 2% 7
  8. 8. NASAL DRUG DELIVERY SYSTEM 8
  9. 9. Inhalation/pulmonary drug delivery system includes Metered dose inhalers Dry powder inhalers Inhalation nasal sprays Inhalation solutions & suspensions (for nebulizers) 9
  10. 10. Nasal Drug Delivery System & Opportunity Annual market growth Merits Limitations 10
  11. 11. Annual growth of locally acting products Annual growth of systemically acting products 11% 30% 11
  12. 12. Lower dose & hence lower side effects Merits... For CNS drugs, better site for rapid onset of action Eg. Inhalation anesthesia, Morphine etc. Useful for both local & systemic drug delivery 12
  13. 13. Limitations Pathologic conditions such as cold or allergies may alter significantly the nasal bioavailability Once administered, rapid removal of the therapeutic agent from the site of absorption is difficult 13
  14. 14. NASAL ROUTE - medical aspects 14
  15. 15.  The respiratory tract, which includes the  nasal mucosa  hypopharynx  large airways &  small airways  provides a relatively large mucosal surface area of approx. 100 m2 (in normal adult) for drug absorption 15 DRUG DELIVERY TO RESPIRATORY SYSTEM
  16. 16. Cross-sectional view Pathways for nasal absorption Nasal site of drug spray & absorption 16
  17. 17. Cross-sectional view 17 a – nasal vestibule d – middle turbinate b – palate e – superior turbinate (olfactory mucosa) c – inferior turbinate f – nasopharynx
  18. 18. Site of drug spray & absorption 18
  19. 19. Pathways for nasal absorption  Absorption into the cerebrospinal fluid  Absorption through the supporting cells & the surrounding capillary bed - venous drainage 19
  20. 20. Transneuronal absorption Olfactory nerve – 1st cranial sensory nerve 20
  21. 21. Venous drainage 21
  22. 22. •Cyto chrome P 450 dependent Lactate dehydrogenase, Oxidoreductase, Hydrolases, lactic dehydogenase, malic enzymes, lysosomal proteinases, steroid hydroxylase. Nasal enzymes Nasal pH •Nasal secretion of adult : 5.5-6.5 •Infants and children: 5-6.7 22
  23. 23. Therapeutic class of drugs for nasal route 23
  24. 24. Therapeutic class of drugs 1. β2 adrenergic agonists 2. Corticosteroids 3. Antiviral 4. Antibiotics 6. More recently, vaccines 5. Antifungal 24
  25. 25. Drugs commonly administered through pulmonary route include 1. Terbutaline Sulphate - β2 adrenergic agonist 2. Salbutamol - β2 adrenergic agonist 4. Ipratropium Bromide - anticholinergic 5. Sodium Chromoglycate – mast cell stabilizer 3. Budesonide - corticosteroid 25
  26. 26. Formulation Development 26
  27. 27. Formulation Development Dosage formDosage form Formulation considerationsFormulation considerations Physiological Pharmaceutical 27
  28. 28. Dosage forms Liquid drop Liquid spray/nebulizers Suspension spray/nebulizers Gel Sustained release Aerosol 28
  29. 29. Physiological effects - Drug metabolism in the respiratory tract & reduction of systemic effect - Local toxic effects of the drug Eg., edema, cell injury, or altered tissue defenses Local or systemic effects of propellants, preservatives, or carriers 29
  30. 30. Pharmaceutical - Physico-chemical properties of a drug candidate - Spray pump devices - Methods to enhance drug absorption 30
  31. 31. 1. Effect of particle size 2. Effect of molecular size 3. Effect of solution pH 5. Effect of drug concentration 4. Effect of drug lipophilicity 31
  32. 32. 1. Effect of particle size (aerodynamic size distribution) - Large particles (> 7 microns) will be lost in the gastrointestinal tract - Intermediate particles (3 to 7 microns) reach the actual site of action - Small particles (< 3 microns) will be lost in exhaled breathe 32
  33. 33. 2. Effect of molecular size - Higher the molecular size, lower the nasal absorption Absorption enhancers: Polyacrylic acid Sodium Glycocholate Sodium Deoxycholate Polysorbate 80 etc. 33
  34. 34. 3. Effect of solution pH - Nasal absorption is pH dependent - Absorption is higher at a pH lower than the dissociation constant (pKa) of the molecule. 34
  35. 35. 4. Effect of drug lipophilicity - - Lipid soluble drugs are absorbed more rapidly than water soluble drugs 5. Effect of drug concentration - Absorption depends on the initial concentration of the drug 35
  36. 36. Methods to enhance nasal absorption of drugs Structural modification Formulation design Salt or ester formation 36
  37. 37. SPRAY PUMP DEVICES - Unidose - Multidose - Bidose 37
  38. 38. Bidose Unidose 38
  39. 39. Multidose 39
  40. 40. Applications Delivery of non-peptide pharmaceuticals Delivery of diagnostic drugs Delivery of peptide-based pharmaceuticals 40
  41. 41. 1. Delivery of non-peptide pharmaceuticals Drugs with extensive pre-systemic metabolism, such as - progesterone - estradiol - propranolol - nitroglycerin - sodium chromoglyate can be rapidly absorbed through the nasal mucosa with a systemic bioavailability of approximately 100% 41
  42. 42. 2. Delivery of peptide-based pharmaceuticals Eg. Insulin, Calcitonin, Pituitary hormones etc. Nasal route is proving to be the best route for such biotechnological products 3. Delivery of diagnostic drugs Diagnostic agents such as • Phenolsulfonphthalein – kidney function 42
  43. 43. CONCLUSION 43
  44. 44. Nasal route is a part of drug delivery strategy that is emerging to be a fastest growing drug delivery system with an annual growth of 11% for locally acting drugs & 30% for systemically acting drugs 44
  45. 45. Nasal drug delivery offers such benefits as Rapid onset of action with lower dose & minimal side effects Has an advantage of site-specific delivery with improved therapeutic effects 45
  46. 46. 46

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