dry powder inhalers

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Information about dry powder inhalers

Published on June 27, 2011

Author: dnyaneshwalunj

Source: authorstream.com

DRY POWDER INHALERS Seminar by: Mr. Dnyanesh R. Walunj II sem.,(Pharmaceutics) SND College of Pharmacy,Babhulgaon ,Yeola : DRY POWDER INHALERS Seminar by: Mr. Dnyanesh R. Walunj II sem.,(Pharmaceutics) SND College of Pharmacy,Babhulgaon ,Yeola 1 CONTENT-: CONTENT- Introduction History Advantages Disadvantages An Ideal DPI DPI design Principle of Operation Excipients Formulation and processing Devices Evaluation parameter Conclusion References 2 Introduction : DPI are devices through which a dry powder formulation of an active drug is delivered for local or systemic effect via the pulmonary route Used to treat respiratory diseases such as asthma, COPD, bronchitis etc. Dry powders for inhalation are formulated either as loose agglomerates of micronized drug particles with aerodynamic particle sizes of less than 5 μm whereas for systemic effects particle size of less than 2 μm is needed for drug deposition in the small peripheral airways. Introduction 3 HISTORY-: 4 HISTORY- The aerosolization or inhalation of medicaments by humans has been used since late the 1950s since 1956, the pressurized metered dose inhaler ( pMDI ) become the most commonly used device to deliver inhaled asthma drugs however, with the advancement of science and technology, pulmonary delivery of drugs has become the route of choice after the introduction of the DPI in 1967. It was only in 1988 that the first true multidose device, the Turbohaler was introduced Slide 5: The human respiratory tract can be divided into 24 generations. Regarding physiological functions, the contiguous airway from the trachea to the terminal bronchioles is called the conducting zone, and the areas from the respiratory bronchioles to the alveolar sacs (generation index 17–23) are called the transitional and respiratory zone. 5 THE HUMAN RESPIRATORY SYSTEM Slide 6: Why use Inhalers? Rapid action Smaller dose is required Portable (Easy to handle) No co-ordination required Suitable for all patient Easy to administration of drug Avoid 1 st pass metabolism Good bioavailability No dose counter is required Slide 7: 7 Typical advantages of dry powder inhalers are  Propellant freed design  Less need for patient coordination  Less potential for formulation problems  Less potential for extractable from device components  Environmental sustainability ADVANTAGES Slide 8: 8 Typical disadvantages of dry powder inhalers  Dependency on patient’s inspiratory flow rate and profile  Device resistance and other design issues  Greater potential problems in dose uniformity  Less protection from environmental effects and patient abuse  More expensive than pressurized metered dose inhalers  Not available world wide DISADVANTAGES Slide 9: 9 AN IDEAL DPI Effective dosing  Targeted and optimized delivery controlled respirable fraction inhalation of dose-independent aerosol generation bolus of aerosol available at the beginning of an inhalation  Operable at low inhalation flow rates Uniform dose through life Slide 10: 10 Efficient device  Good environmental production  Design optimized by the use of, for example, practical engineering, manufacturing innovation  In-process controls for quality  Compact, portable, cheap and reusable  Clear comparative data for compliance. Easy to use  Simple operation  Dose counter Slide 11: 11 DPI design must be coordinated with the formulation of the drug. The geometry of the mouth piece is critical parameter DPI design Slide 12: 12 When the patient activates the DPI and inhales, airflow through the device creates shear and turbulence, introduced into the powder bed and fluidized then enters the patient’s airways. the drug particles separate from the carrier particles and are carried deep into the lungs, while the larger carrier particles impact in the oropharynx and are cleared. Principle of operation Slide 13: 13 PRINCIPLE OF OPERATION Excipients : Currently, lactose is the only excipient used in DPIs Lactose is highly crystalline and has the smooth surfaces and satisfactory flow properties desirable for a DPI carrier particle One drawback of lactose is that it is a reducing sugar, which makes it incompatible with drugs that have primary amine moieties. It should also be noted that excipients are not always required; the Pulmicort (budesonide) Turbuhaler (AstraZeneca, Wilmington, Delaware) is an example of an excipient-free formulation 14 Excipients Internal Impaction : 15 Internal Impaction Fig. Micronization. Cross-sections of 3 mills commonly used to create micron-size particles. A: Jet mill. B: Pin mill. C: Ball mill. Cascade Impactor: Cascade Impactor 16 Slide 17: 17 FORMULATION AND PROCESSING 1) Controlled Crystallization or Precipitation 2) Micronization 3) Blending 4) Pelletization Secondary Processing 1) Spray Drying 2) Lyophilization 3) Supercritical Fluid Technology Slide 18: 18 FILLING AND PACKAGING Unit-Dose Systems Unit-dose systems package drug powders into individual-use packages that contain a known quantity of drug. The greatest advantage of unit-dose systems is that a greater degree of control at the manufacturing level can be maintained. Unit-dose systems typically rely on blister packaging or capsules to contain the drug until it is dispersed by the delivery device . Slide 19: 19 Reservoir Systems Reservoir systems offer the advantage of variable dosing, generate less waste, are less expensive to manufacture, and are simpler to use than unit-dose systems Maintaining a highly flowable drug powder in this system may also lead to greater drug formulation challenges . Slide 20: 20 Devices used in inhalation THERAPY Technique for using a dry powdered medication is: 1. Exhale away from device 2. Put mouthpiece in your mouth 3. Breath quickly. Dry powder inhaler include….. 1. Aerolizer® 2. Diskus® 3. Flexhaler® 4. Handihaler® 5. Rotahaler® 6. Turbuhaler® 7. Twisthaler® Slide 21: 21 1. Aerolizer : Breath activator 2. Diskus : Breath activator 3. Flexhaler Slide 22: 22 4. Handihaler 5. Rotahaler 6. Turbuhaler Slide 23: 23 7. Twisthaler Benefits of DPI : convenient and easy to use dispense medicine directly where it is needed on set of action, without need for absorption, digestion and circulation can deliver both long-lasting / short-acting anti-inflammatory agent. quick-relief in case of bronchodilation. rd: rd Current DPI devices available in the market Device DPI Product Company Delivery method Drugs Diseases 1 st generation: Spinhaler ® Single dose Aventis Capsule SC Asthma Rotahaler ® Single dose Pharmachemie Capsule SS Asthma 2 nd generation: Turbohaler ® Multi dose AstraZeneca Reservior SS Asthma Diskhaler ® Single dose GSK Blister pack SX Asthma & Influenza 3 rd generation: Exubera ® Single dose Pfizer Blister pack INSULIN Diabetes Airmax ® Multidose Norton Healthcare Reservior FORMOTEROL COPD Evaluation: 1. Appearance and colour 2. Identity(chromatography and spectroscopy) 3. Microbial limits 4. Water / moisture content 5. Assay (drug content determination) 6. Particle size analysis / respirable dose 7. Averages fill weight per capsule 8. Locking length 25 Evaluation References: Nazrul Islam, Ellen Gladki ,” Dry powder inhalers (DPIs)-A review of device reliability and innovation”, International Journal of Pharmaceutics 360 (2008) 1–11. J. Peart and M.J. Clarke, New developments in dry powder inhaler technology, Am. Pharm. Rev. 4 (2001) 37, 38, 40, 42–45. A. Hersey, Ordered mixing: a new concept in powder mixing practice, Powder Technol. 11 (1975), pp. 41–44. S.P. Newman, D. Pavia and S.W. Clarke, How should a pressurized beta-adrenergic bronchodilator be inhaled?, Eur. J. Respir . Dis , 62 (1981), 3–21. J. Hickey, Pharmaceutical Inhalation Aerosol technology (second edition), Marcel Dekker, NY, USA (2004). Remington. The Science and Practice of Pharmacy, Lippincot William and Wilkins publication, 21 st edition, Vol-1;Pg:1047 Ian Ashurst , Ann Malton , David Prime and Barry Sumby , Latest advances in the developmentof dry powder inhalers , Elsevier Science Ltd, Vol. 3, No. 7 July 2000, 26 References Slide 27: T. Freedman, Medihaler Therapy for bronchial asthma: a new type of aerosol therapy, Postgrad . Med. J. 20 (1956), pp. 667–673 Vitthal S. Kulkarni . Handbook Of Non Invasive DDS , Elsevier Inc.Publication , First edition 2010, 1123-1143 Edited by Anthony J, Hickey Anthony J, Hickey David C, Thompson, Pharmaceutical Inhalation Aerosol Technology, Second Edition, Revised and Expanded by Marcel Dekker 2004 Hofmann, W., Strum, R., Winkler- Heil , R., Pawlak , E., Stochastic model of ultrafine particle deposition and clearance in the human respiratory tract. Rad. Prot. Dosi.105 (1–4), 2003, 77–80. Alagusundaram M, Deepthi N, Ramkanth S, Angalaparameswari S, Mohamed Saleem T.S, Gnanaprakash K, “ Dry Powder Inhalers - An Overview”, Int. J. Res. Pharm. Sci. Vol-1, Issue-1, 2010, 34-42. 27 : THANK YOU!!!

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