Formulation Considerations for Inhaled Products课件.ppt

精品文档 Point out new generation nebulizer type devices Point out trend to engineered particles Formulation Considerations for Inhaled Products Formulation Considerations of Inhaled Products Inhalation Therapy Metered Dose Inhalers (MDI) and Formulations Dry Powder Inhalers and Formulations Conclusions Nebulizers and Formulations 精品文档 Inhalation Therapy Inhalation Therapy Refers to Direct Delivery of the Medications to/via the Lungs by Inhalation Regional Therapeutic Effect Respiratory Disease Asthma and Chronic obstructive pulmonary disease (COPD) Pulmonary Hypertension Systemic Therapeutic Effect Migraine Ergotamine Tartrate Parkinson’s Disease Apomorphine Hydrochloride Diabete Mellitus Inhaled Insulin Advantages of Inhalation Therapy Delivery of the Medications Directly to the Action Site Rapid Onset Enhanced Bioavailability by Avoiding First Pass Effect 精品文档 Challenges in Inhalation Drug Delivery Dealing with small particles Less than 5 μm, majority 2-3 μm in order to reach bronchial regions Turbulent ??D2, F2/3, V-1/4 Impaction ??D2, U Extra-Thoracic Deposition Impaction ??D2, U Sedimentation ??D2, T Bronchial Deposition Diffusion ???T/D)1/2 Alveolar Deposition 精品文档 Impact of Small Particles on Inhalation Formulations Formulation Challenges Formulation uniformity, e.g. dry powder inhaler, suspension MDI and nebulizer formulations Cohesive forces Re-dispersion and aerosolization of drug particles Powder flow Physical stability and impact on product performance, .e.g. Aggregation Bridging ?stwald ripening Batch-batch variability (drug excipients) Size Shape Morphology Amorphous content Etc 精品文档 Impact of Formulations on Inhaler Performance Consistent Aerodynamic Particle Size Distribution (Fine Particle Dose / Fraction) Chemical and Performance Stability Consistent Delivered Dose Through Inhaler Life 精品文档 Formulation Considerations of Inhaled Products Inhalation Therapy Metered Dose Inhalers (MDI) and Formulations Dry Powder Inhalers an