RECENT ADVANCES IN LIPOSOMAL DRY POWDER INHALER FORMULATIONS FOR PULMONARY DISORDER
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1 RECENT ADVANCES IN LIPOSOMAL DRY POWDER INHALER FORMULATIONS FOR PULMONARY DISORDER Ambikanandan Misra, Professor of Pharmaceutics & Head, Pharmacy Department TIFAC CORE IN NDDS PHARMACY DEPARTMENT FACULTY OF TECHOLOGY & ENGINEERING. KALABHAVAN M.S. UNIVERSITY OF BARODA, VADODARA , GUJARAT
2 Advantages of the Inhaled Dosage form Act quickly but short lived action Minimize the dose required Are non-invasive Minimizes side effects Avoids hepatic first-pass metabolism Are systemically absorbed
3 The Keys to Successful Pulmonary Drug Delivery Identified target Specific drug Excellent drug delivery system Device Formulation Efficient patient and practitioner education
4 Ideal Therapeutic Aerosols Contain a safe and efficacious drug! Contain minimal quantities of inert excipients Monodisperse, small particle size Low velocity after generation High concentration and rate of generation Highly reproducible characteristics Low bioburden (solids) or sterile (liquids)
5 Factors Affecting Lung Deposition Inhaled Particles Size Shape, Density, Charge, Hygroscopicity Patient Lung Anatomy Disease State Breathing Pattern Aerosol Generation Device Principle and Design Features Deposition depicted by gamma scintigraphy from Pharmaceutical Profiles
6 Pulmonary Delivery of Therapeutics, Peptides, Proteins and Genes Formulation Challenges Insoluble drugs Shear sensitive Thermolabile Excipients Conformational changes Instability Particle Engineering Microspheres Liposomes Porous particles PEGylated particles Device Platforms Pressurized metered dose inhalers (pmdi) Nebulizers Dry powder inhalers (DPI) Single breath liquid systems
7 LUNG DISEASES WHICH CAN BE TARGETED BY LIPOSOMAL DPI Asthma Chronic obstructive pulmonary disease (COPD). Lung cancer Cystic Fibrosis and associated lung infections Local Pain Pneumonia Local fungal infection Pulmonary Tuberculosis
8 DPI CONVENTIONAL DPI MIXING OF DRUG AND CARRIER LACTOSE AND DELIVERY TO LUNG HAVE DISADVANTAGE OF HIGH AND REPEATED DRUG DOSING AND LOW PULMONARY BIOAVAILABILITY. NOVEL & ENGINEERED DPI USE OF TERNARY MIXTURES ALTERING PHYSICAL SHAPE, LENGTH, DENSITY OF THE CARRIER LACTOSE USE OF LIPOSOMES AND NANOPARTICLES AS DRUG CARRIER LOW DENSITY PARTICLES USE OF LESS COHESIVE AND ADHESIVE, WRINKLED PARTICLES.
9 DRY POWDER INHALERS ADVANTAGES: Automatic coordination. No propellants. Drug stability advantages. High drug dose carrying capacities. High reproducibility (Monodisperse) Minimal extrapulmonary loss of drug due to low oropharyngeal deposition, low device retention and low exhaled loss. CONTEMPORARY ISSUES OF DPI: Effort Dependant (Potential for poor repeatability and unsuitable for young children). Drug deposition in deep lung for systemic absorption. Large fraction of coarse articles (Increase upper airway deposition)
10 Why Use Liposomes in Drug Delivery? Prolonged pulmonary retention (Changed Pharmacokinetcs) Enhanced cellular uptake (Pharmacological response). Liposomal membrane composition and surface properties Patentability of drug. Reduced side effects due to slow systemic dilution. Protection of drug from enzymatic degradation
11 Why Use Liposomes in Pulmonary Drug Delivery? Drug Targeting: Nanoliposomes for avoiding alveolar macrophage uptake. Liposomes localization in Macrophages in Lung Fungal infections. Surface Modification through ligand (antibodies, enzymes, protein A, sugars) in liposomes. ph responsive liposomes for tumor specific drug release. Hence Lower Dose and Less Adverse Reactions.
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13 Liposomal DPI Preparation Lyophillization Spray drying Use of carrier lactose, cyroprotectant, amino acids, lipids during freeze and spray drying. Dry Liposomal Powder Enhanced DPI Properties Use of Ternary Mixtures and effect of fines Altered physical shape, density, porosity Less cohesive and adhesive particles, lubricants
14 Process flow chart Formulation of Liposomes Method of Preparation Thin film Hydration Reverse Phase evaporation Microfluidization and spray drying Characterization Drug entrapment Entrapment Efficiency Particle size & Drug release Lamellarity Stability and drug retention studies Drug - Lipid selection Drug - lipid Ratio PC-Cholesterol Ratio Charge on liposome Formulation of Dry Powder Inhalers Process optimization Hydration volume Hydration time Sonication frequency & time Liposomal Dry Powder Inhalers Method: Lyophilization (Rate of cooling, drying, Vacuum ) Spray Drying Ternary Mixtures Characterization Water content Carrier ratio Particle size Degradation Drug leakage Drug release & Stability Cryoprotectant Selection Type Ratio Process optimization Freezing time Drying time In vitro characterization Emitted dose Fine particle fraction (Twin Stage Impinger/ Flowability Density Cascade Impactor) In vivo characterization (in animal models) Pharmacokinetic evaluation Pharmacodynamic evaluation
15 Our Research Achievements and Contributions
16 Pharmaceutical development of liposomal DPI formulations Evaluation & Optimization of flow and dispersion (deaggregation) characteristics (drug at the desired site) Objectives In vivo evaluation on atleast two animal models and if possible, the clinical evaluation of the potential formulations. Development of systemic DPI systems for polypeptides, genetically engineered drugs and other drugs of importance.
17 Lung localization of drug maximizes the therapeutic index minimizing unwanted systemic activity or toxicity Drug distribution limited to the intended site of action in the lung provides - maintenance of prolonged therapeutic levels - slow systemic dilution Pulmonary DPI Formulations -Reduction in dose, duration of therapy and systemic sideeffects - reduce the cost of therapy Hypothesis Enhancement of Pulmonary absorption - Protein, peptides and genetically engineered drugs - Other drugs for compliance and ease of delivery
18 Our Research Achievements: Ketotifen Fumarate, Budesonide Salbutamol and Terbutaline Sulphate, Mometasone Furoate (Lectin Conjugated Nanoparticle s) Antiasthamatic - Spray dried Porous and Lyophillized Light and Large particles developed. - Higher cellular uptake and enhanced antiproliferative activity in A-549 cell lines
19 Our Research Achievements: Comparative pulmonary drug release from LDPI of Ketotifen
20 Our Research Achievements continued 2. Amphotericin B Antifungal - Spray dried Porous and Lyophillized Light and Large particles developed. - In vivo Animal experimentation and clinical evaluation for set goals in progress.
21 Our research achievements continued 3. Insulin Calcitonin Proteins & Peptides -Increased relative bioactivity in animals of 155.6% and 139.0% achieved -DPI formulations showed promising in vitro deposition
22 Our research achievements continued Enhanced Pulmonary Absorption of Peptides
23 Our research achievements continued 4. Levonorgesterol Leuprolide Contraceptives 100% Male and Female contraception achieved in rats.
24 Our research achievements continued Plasma Levonorgestrel level (ng/ml) Mean Plasma level of Levonorgestrel in rats st Qtr 2nd Time(hrs) Qtr 3rd Qtr 4th Qtr LO Plain drug East West North Mixture of constituents Liposomes
25 5. Our research achievements continued Amikacin sulphate and Tobramycin sulphate Cystic Fibrosis -Spray dried Porous and Lyophillized Light and Large particles developed - In vivo evaluation indemonstrated prolonged drug levels in lung in rats
26 6. Our research achievements continued Tacrolimus Immunosupression After lung transplantation -Nanoliposomal DPI with trehalose -In vivo evaluation in rats demonstrated prolonged drug levels in lung.
27 7. Our research achievements continued Dapsone Pneumocystis carinii pneumonia (PCP) -Nanoliposomal DPI with hydrolized gelatin In vitro release upto 24 hrs in Phosphate buffer ph 7.4 saline observed.
28 Ongoing.. Gene Delivery Cystic Fibrosis, & Lung Cancer -Incarporation of genes (CFTR, p53 ) in liposomes for intranuclear targeting
29 FEW CASE STUDIES FROM LITERATURE : Opoid Analgesics LIPOSOMAL DPI BY PULMONARY ROUTE -Local as well as systemic analgesia, better than solution administered parentrally (iv, im) and oral. [Ref] Bystrom, K., Nilsson, P.: US20001RE38407 (2001).
30 FEW CASE STUDIES FROM LITERATURE : Corticostero idal Derivatives LIPOSOMAL DPI BY PULMONARY ROUTE Prolonged steroid retention in respiratory tract, improved therapeutic ratio, lower toxicity, reduced systemic side effects, and stability for several months Interstitial Diseases of Lung [REF] Radhakrishnan, R.: US (1991).
31 FEW CASE STUDIES FROM LITERATURE : Nanocochle ates NANOCOCHL- EATES DPI BY PULMONARY ROUTE -Liposome + Polymer solution treated with Ca++ or Zn++, yields precipitate of Nanocochleates (nm) - Achieve efficient systemic and mucosal delivery [REF] Parmar,M.: US A1 (2006).
32 FEW CASE STUDIES FROM LITERATURE : Proliposomes Antibacterial Agents - Comprises Lipid of suitable Tg and antibacterial agent. - On inhalation the drug spontaneously encapsulates into lipid inside lungs. - Useful for Anthrax Therapy [REF] Weers,J.G., Tarara, T., Tzannis, S.: US A1 (2005).
33 S.No. Authors Title of paper Research Publications Name of journal Vol. (No) Pages Year INTERNATIONAL 1. Mayank Joshi, Ambikanandan Misra DPI of liposomal Ketotifen Fumarate: Formulation and Characterization Int. J. Pharm Mayank Joshi, Ambikanandan Misra Liposomal Budesonide for Dry Powder Inhalation: Formulation & Stabilization AAPS PharmSciTech 2 (4) Article Mayank Joshi, Ambikanandan Misra Pulmonary disposition of Budesonide from Liposomal Dry Powder Inhaler Methods Find Exp Clin Pharmacol 23 (10) Mayank Joshi, Ambikanandan Misra Disposition kinetics of liposomal dry powder inhaler of Ketotifen fumarate in rats Clin. & Exp. Pharmacol. & Physiol. 30 (3) T.Mahesh Kumar, Ambikanandan Misra Influence on Absorption Promoters on Pulmonary Insulin Bioactivity AAPS PharmSciTech 4 (2) Ambikanandan Misra and Aliasgar Shahiwala Pulmonary Absorption of Liposomal Levonorgestrel AAPS PharmSciTech 5(1) Shah S.P., Misra Ambikanandan, Development of Liposomal Amphotericin B Dry Powder Inhaler Formulation Drug delivery 11 (4) Shah S.P., Misra Ambikanandan, Liposomal Amikacin Dry Powder Inhaler: Effect of Fines on In Vitro Performance AAPS PharmSciTech 5 (4) Article
34 S.No. Authors Title of paper Name of journal Vol. (No) Pages Year 9. T. MaheshKumar, Ambikanandan Misra Pulmonary Absorption Enhancement of Salmon Calcitonin Journal of Drug Targeting 12 (3) Shah S.P., Misra Ambikanandan, Liposomal Amphotericin B dry powder inhaler: Effect of fines on in vitro performance Pharmazie 59 (10) Aliasgar Shahiwala, Ambikanandan Misra A preliminary pharmacokinetic study of liposomal leuprolide dry powder inhaler: a technical note. AAPS PharmSciTech 6 (3) E Ambikanandan Misra, M. B. Chougule, B.K. Padhi Nano-liposomal Dry Powder Inhaler of Amiloride Hydrochloride Journal of Nanoscience and Nanotechnology 6 (9-10) Ambikanandan Misra, M. B. Chougule, B.K. Padhi Preparation, characterization, and pharmacokinetics of nano-liposomal dry powder inhaler of Tacrolimus International Journal of Nanomedicine 2(4) T. Mahesh Kumar, Ambikanandan Misra Formulation and Evaluation of Insulin Dry Powder for Inhalation Drug Development and Industrial pharmacy 32 (6) Ambikanandan Misra, M. B. Chougule, B.K. Padhi Optimization of formulation components and characterization of large respirable powders containing high therapeutic payload Pharmaceutical Development Technology 11(4) Naazneen Surti, Sachin Naik, and Ambikanandan Misra Assessment of in-vitro antiproliferative activity of WGAconjugated budesonide nanoparticles in A-549 cells Journal of Biomedical Nanotechnology 3 In Press 2007
35 S.No. Authors Title of paper Name of journal Vol. (No) Pages Year NATIONAL 17 Mayank Joshi, Ambikanandan Misra Liposomes of Terbutaline Sulphate:Preparation, Optimization and Stability Studies Indian Drugs 36 (4) Mayank Joshi, Ambikanandan Misra Liposomes of terbutaline sulphate: In vitro and in vivo studies Ind. J. Exp. Biol. 37 (9) Mayank Joshi, Ambikanandan Misra Spectrophotometric determination of Budesonide Indian J. Pharm. Sci REVIEWS AND GENERAL ARTICLES 20 S.P. Shah. S. Ganesh and A.N. Misra Factors Affecting Development of Dry Powder Inhalers Indian J. Pharm. Sci. 65(4) Ambikanandan Misra Dry Powder Inhaler: Novel approaches Pharmabiz Sept Ambikanandan Misra, M. B. Chougule, B.K. Padhi, K.A. Jinturkar Development of Dry Powder Inhalers Recent Patents on Drug Delivery & Formulation,
36 PATENTS FILED: Sr. No. Inventors Tile of patent Date of filing Patent office no. 1 Ambikanandan Misra, Bijay Kumar Padhi, Mahavir Bhupal Chougule Engineered Monodisperse Inhalation Powders for Effective Treatment of Lung Diseases. 25 th Feb, /MUM/ Ambikanandan Misra, Mahavir Bhupal Chougule, Bijay Kumar Padhi, Enhancement of Pulmonary Therapeutic Index of Drugs from Dry Powder Inhaler Formulations. 27 th May /MUM/ Ambikanandan Misra, Mahavir Bhupal Chougule, S. Ganesh, Bijay Kumar Padhi. Aerodynamically light porous dry powder inhaler formulations for targeted pulmonary deposition 30 th June, /MUM/200 6 Book published Misra A.N., Advances In Pulmonary Drug Delivery in Advances in Controlled & Novel Drug Delivery (N.K. Jain Eds.), CBS Publishers & Distributors, New Delhi, pp (2001).
37 Future Research Focus Cell Culture Studies Cellular uptake using Calu- 3, Alveolar A-549, MAC-7 Epithelial monolayer, MS-H macrophage cell line. Permeation through alveolar monolayer (Paracellular Transport, Transcellular Transport) Cellular and Molecular Studies Animal Studies and clinical evaluation Pilot Scale up of Formulations
38 CONCLUSION The pulmonary liposomal drug delivery has been very advantageous for prolonged and cell specific delivery of drugs. The recent advances in the postgenomic era and molecular biology, has improved it further. However, intracellular targeted therapy of therapeutic (specially biological) molecules using liposomal carrier with high safety and efficacy is the need of hour.
39 Thank You!
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