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Nasal drug delivery system

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  • 1. 1 RESPIRATORY DRUG DELIVERY SYSTEM BY SUNILBOREDDY
  • 2. Novel Drug Delivery System Nasal Drug Delivery System Medical aspects Formulation Development Applications Conclusion CONTENTS 2
  • 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. By 2010, the US drug delivery market alone will be worth $30 billion 4
  • 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. Drug Delivery Systems Oral Inject- able Mucosal Trans- dermal Ocular Vaginal/ Anal Needle Needle- less Nasal Buccal Pulmo- nary Active Passive Topical 6
  • 7. Global drug delivery market by administration mode Oral 53% Inhalation 32% Transdermal 8% Injectable/ Implant 3% Ocular 2% Nasal 2% 7
  • 8. NASAL DRUG DELIVERY SYSTEM 8
  • 9. Inhalation/pulmonary drug delivery system includes Metered dose inhalers Dry powder inhalers Inhalation nasal sprays Inhalation solutions & suspensions (for nebulizers) 9
  • 10. Nasal Drug Delivery System & Opportunity Annual market growth Merits Limitations 10
  • 11. Annual growth of locally acting products Annual growth of systemically acting products 11% 30% 11
  • 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. 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. NASAL ROUTE - medical aspects 14
  • 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. Cross-sectional view Pathways for nasal absorption Nasal site of drug spray & absorption 16
  • 17. Cross-sectional view 17 a – nasal vestibule d – middle turbinate b – palate e – superior turbinate (olfactory mucosa) c – inferior turbinate f – nasopharynx
  • 18. Site of drug spray & absorption 18
  • 19. Pathways for nasal absorption  Absorption into the cerebrospinal fluid  Absorption through the supporting cells & the surrounding capillary bed - venous drainage 19
  • 20. Transneuronal absorption Olfactory nerve – 1st cranial sensory nerve 20
  • 21. Venous drainage 21
  • 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. Therapeutic class of drugs for nasal route 23
  • 24. Therapeutic class of drugs 1. β2 adrenergic agonists 2. Corticosteroids 3. Antiviral 4. Antibiotics 6. More recently, vaccines 5. Antifungal 24
  • 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. Formulation Development 26
  • 27. Formulation Development Dosage formDosage form Formulation considerationsFormulation considerations Physiological Pharmaceutical 27
  • 28. Dosage forms Liquid drop Liquid spray/nebulizers Suspension spray/nebulizers Gel Sustained release Aerosol 28
  • 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. Pharmaceutical - Physico-chemical properties of a drug candidate - Spray pump devices - Methods to enhance drug absorption 30
  • 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. 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. 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. 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. 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. Methods to enhance nasal absorption of drugs Structural modification Formulation design Salt or ester formation 36
  • 37. SPRAY PUMP DEVICES - Unidose - Multidose - Bidose 37
  • 38. Bidose Unidose 38
  • 39. Multidose 39
  • 40. Applications Delivery of non-peptide pharmaceuticals Delivery of diagnostic drugs Delivery of peptide-based pharmaceuticals 40
  • 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. 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. CONCLUSION 43
  • 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. 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