Ppt on dry powder inhalers

Dry Powder Inhalers

1. Vishnu Institute of Pharmaceutical Education and Research Dry powder Inhalers By: MR. B CH S NAGA RAJU M pharm 1st year Guided by: Dr. K. Vanitha, Ph. D. Department of Pharmaceutics

2. Contents: Introduction & Definition Types of DPI Characteristics Advantages Disadvantages DPI formulation Carriers used in DPI Techniques for DPI Characterization of DPIs

3. INTRODUCTION What are dry powder inhalers

4. Dry Powder Inhalers (DPIs) DPI is device that delivers medication to the lungs in the form of dry powder. DPIs are also commonly used to treat Respiratory Diseases such as asthma, bronchitis, emphysema and COPD. Either in a capsule or Inside the inhaler itself. Once l o aded o r a c t u ated, t h e op erat o r p u ts t h e mo u thpiece o f t h e inhaler into the mouth and takes a deep inhalation. Continue …..

5. Commonly used to deliver medications such as inhaled corticosteroids into the lungs. This inhaler is breath-activated. The medication is released only when you take a deep, fast breath in through the inhaler. This is different than a metered dose inhaler that pushes medication into the lungs. Marketed examples of dry powder inhalers include: Eg’s: Advair Diskus, Asmanex, Pulmicort flexhaler.

6. Single dose Eg : Nectar pulmonary inhaler Types of DPI’S

7. Ideal Characteristics required for DPI’s Effective Dosing. Uniform dose through out life. Targeted and optimize 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. Continue …..

8. Good Environmental production. Des i gn o p tim i z e d b y the use of, for e. g . , part i c l e en g in e e rin g , manufacturing innovation, etc. In-process controls for quality. Compact, Portable, Cheap, Reusable and Efficient device. Clear comparative data for complaint.

9. ADVANTAGES For m ulation stability. No need to hold breath Breath Activated Environ m ental sustainability Propellant free design No coordina t ion required. Less potential for formulation problems. Less potential for extractable from device components.

10. DISADVANTAGES Development and m a nufa c t u r i ng is more complex than pMDI. Have adequate inhalation. More expensive than pMDIs. Less protection from environmental effects. Deposition efficiency depends on patients inspiratory airflow. Age depe nd e nt

11. DPI Formulation Considerations: Consist of the carrier powder mixed with drug (API). Particle size of drug should be < 5 μm. The m ic r o n iza t i o n o f d r ug is don e b y m ill i ng, s p ray d r yin g , and supercritical fluid extraction. Micronized drug particle achieve good aerodynamic properties of the dispersed powder. Improvement in formulation performance by development of tertiary excipients like magnesium stearate and leucine . H elps in i m p r o v ing the perf o r m ance of f o r m ulation by int e rferi n g with inter-particle bonding due to its antiadherent action.

12. Carriers used in DPIs Used to improve drug particle flow ability, improving dosing accuracy, minimizing the dose variability. T o fa c ilit a te the e a s y e m is s ion of drug particles from c a ps u les and devices, thereby increasing the inhalation efficiency. Design of the carrier particle is important for the development of DPIs. C hara c terist i cs o f c a rr i er particles i nclude p h ysi c o -che m ical stabi l it y , biocompatibility and biodegradability. S h o uld b e co m pati b le with t he d r ug sub s t a nce and m u s t b e i n ert, available and economical. Examples of carriers: Lactose, mannitol, glucose, sorbitol, maltitol, and xylitol.

13. Advantages of lactose as a carrier Well-investigated toxicity profile Physical and chemical stability Compatibility with the drug substance Broad availability Low cost.

14. A) Controlled crystallization or precipitation: Cry s ta l liz a tio n , o r p r e c i p i tat i o n , is t he p r ocess b y whi c h particles a re p r o d uced f r om s o lution o f t h e m ate r ial in a s u i table solvent. The f o r m at i on of a stable, crysta l li n e m a terial is n o r m ally the target of this final step. In the production of materials for use in DPI products, however, the particle size of the crystallized product is normally too large. Subsequent reduction in particle size is then necessary and can significantly alter the physical nature of the material.

15. B) Micronization: Micronization involves high energy particle-size reduction technique that can convert coarse-diameter particles into particles <5µm in diameter. Types of equipment used as, jet or fluid energy mills and ball mills. All techniques involve applying a force on the particle, typically in the form of a collision, either particle-particle or particle-equipment. As the size of the particle decreases, the number of imperfection decreases.

16. C) Blending: It serves as a commonly used method for improving the flow ability, fill ability, and dispersability of small cohesive particles wherein the drug is blended with excipients particles. The objective of the mixing process is to produce an ordered powder in which the small particles attach themselves to the surface of larger “carrier” particles. The final product performance of a powder blend in DPI is ultimately depends on the individual drug and carrier properties as well as on the process by which they are blended.

17. D) Palletization: The p r ocess involves deliber a te aggl o m er a ti o n of the fi n e d r ug material into less cohesive, larger units. Palletization is usually achieved by vibratory sieving or any process that tumbles powder. The resul t ant p e ll e ts m ust be used in a sys t em c a pable of deaggregating to an appropriate particle size for aerosol drug delivery.

18. Characterisation of DPIs Appearance & Colour: It should be checked for drug and device If any colour is present with the formulation, quantitative test with relevant acceptance criteria should be established Particle Size Analysis: Sieve Analysis Sieve Shaker Air-jet Sieving Laser Diffraction Sympatec (0.25 µm - 1750 µm) and Malvern (0.01 µm- 6000 µm) supplies instruments for laser defraction. Moisture Content: Affectes Aerosolization of the particles, particle size distribution, crystallinity, dose content uniformity, microbial content, and stability. Karl Fisher method Impurities and Degradation Products: Acceptance criteria should be set for individual and total degradation products and maximum impurities. Drug is checked whether is in specified limit or not.

19. Drug Content (Assay): Should be determined analytically with a stability indicating method. Acceptance criteria should as high as possible. Microbial Limits: Total Aerobic Count Total Yeast Count Mold Count Indicator Pathogens Delivered Dose Uniformity: Both air flow rate and total volume of air drawn through the device should be thoroughly evaluated. Volume of air drawn through the device be limited to two litres . Apply For both D-M DPI & P-M DPI.

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