Introduction to Novel Drug Delivery Systems
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Full lecture is available in youtube Part1: https://youtu.be/-8v5VmM-kVg Part2: https://youtu.be/TdrEUEDAcbU The Lecture includes: Introduction to Novel Drug Delivery Systems What is Drug? Drug Discovery and Drug Development Challenges in Drug Discovery & Drug Development Novel Drug Delivery Systems Conventional vs Novel Drug Delivery Systems Various Novel Drug Delivery Systems NDDS Course contents are available at https://theabhi.in/pharma/ndds
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Introduction to Novel Drug Delivery Systems
- 1. by Abhijit Debnath Asst. Professor NIET Pharmacy Institute Greater Noida
- 2. Abhijit Sir TheAbhi.in Outline of the Talk
- 3. Abhijit Sir TheAbhi.in Drug & Formulation Basic understanding of Drug 01
- 4. Abhijit Sir TheAbhi.in Drug & Formulation A drug is any substance that causes a change in an organism's physiology or psychology when consumed In pharmacology, a drug is a chemical substance, which administered to a living organism, produces a biological effect. A Drug is a chemical substance used to treat, cure, prevent, or diagnose a disease or to promote well-being. 01 Drug
- 5. Abhijit Sir TheAbhi.in Aspirin, Penicillin, Morphine Methoxamine, Meperidine Atropine bromide, Penicillin substrates Natural Derivatives Natural Synthetic Drug & Formulation 01 Drug
- 6. Abhijit Sir TheAbhi.in No Side effects Effective ADME Non-Toxic Safe High Efficacy No Adverse Reaction Drug & Formulation 01 Quality of a Good Drug
- 7. Abhijit Sir TheAbhi.in Drug & Formulation 01 Drug Delivery System Drug delivery is the method or process of administering a pharmaceutical compound to achieve a therapeutic effect in humans or animals. Drug delivery system is often used to refer to the way dosage form releases the drug and delivers it to the target organ, tissue, cell or even cellular organelle.
- 8. Abhijit Sir TheAbhi.in Formulation Drug & Formulation 01 What is Formulation? API Excipients
- 9. Abhijit Sir TheAbhi.in Formulation Drug & Formulation 01 What is Formulation? API Excipients
- 10. Abhijit Sir TheAbhi.in Drug & Formulation 01 Dosage forms Dosage forms are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components, in a particular configuration, and apportioned into a particular dose. Dosage Form Route of administration • Oral • Tablets • Capsules • Solutions • Syrups • Elixirs • Suspensions • Magmas • Gels • Powders • Sublingual • Tablets • Troches and Lozenges • Parenteral • Solutions • Suspensions • Conjunctival • Contact lens inserts • Ointments
- 11. Abhijit Sir TheAbhi.in Drug & Formulation 01 Difference between dosage form and drug delivery Dosage form and Drug delivery system can be used interchangeably, dosage form is often used to refer to the physical appearance of drug like tablets, capsules, syrups, ointment and creams whereas the drug delivery system is often used to refer to the way dosage form releases the drug and delivers it to the target organ, tissue, cell or even cellular organelle For example, OROS system of nifedipine (Procardia tablet by Pfizer): Dosage form is tablet but OROS system is the drug delivery system where the drug is released through laser drilled orifice in the semipermeable membrane either by the action of osmotic effect of KCL pushing layer or effervescent pushing layer. Drug Delivery system
- 12. Abhijit Sir TheAbhi.in A Drug Should Be Therapeutically Effective Should Bind with Specific Target Should not Posses Off- Target Binding Should be stable with Specific Target
- 13. Abhijit Sir TheAbhi.in A Drug Should Be Free from Side-Effects
- 14. Abhijit Sir TheAbhi.in A Drug Should Be Should not be Harmful to Environment and Bio-Diversity
- 15. Abhijit Sir TheAbhi.in Drug Discovery & Drug Development From Concept to Market 02
- 16. Abhijit Sir TheAbhi.in Drug Discovery & Drug Development 02 Steps involved in Drug Discovery and Drug Development
- 17. Abhijit Sir TheAbhi.in Steps involved in Drug Discovery and Drug Development Discovery of New Drug Molecule Pre Clinical Studies Early Formulation Development Clinical Studies New Drug Application Industry Scale Production pharmacovigilance Marketing
- 18. Abhijit Sir TheAbhi.in Drug discovery y Drug Development Drug Regulatory Affairs Discovery of New Drug Molecule Pre Clinical Studies Early Formulation Development Clinical Studies New Drug Application pharmacovigilance Industry Scale Production Marketing Discovery of New Drug Molecule
- 19. Abhijit Sir TheAbhi.in Drug Discovery & Drug Development 02 FDA Approved Drugs Year wise
- 21. Abhijit Sir TheAbhi.in Challenges in Drug Development Issues associated with Failure of Drug 03
- 22. Abhijit Sir TheAbhi.in 30,000 Diseases Reported in ICD10 ~2023 FDA Approved Drugs 46 Vaccines Challenges in Drug Discovery 03 Challenge No# 1 New Diseases
- 23. Abhijit Sir TheAbhi.in Challenges in Drug Discovery 03 Challenge No# 2 Arduous and time-consuming
- 24. Abhijit Sir TheAbhi.in Challenges in Drug Discovery 03 Challenge No# 3 Expensive
- 25. Abhijit Sir TheAbhi.in Challenges in Drug Discovery 03 Challenge No# 4 Valley of Death
- 26. Abhijit Sir TheAbhi.in Challenges in Drug Discovery 03 Challenge No# 5 Drug Recall
- 27. Abhijit Sir TheAbhi.in Challenges in Drug Discovery 03 Challenge No# 6 Low Success rate
- 28. Abhijit Sir TheAbhi.in Challenges in Drug Discovery 03 Challenge No# 7 Toxicity Toxicity 30% of lead candidates fail due to Toxicity. Toxicity related to human organs, long term genomic toxicity or Toxicity Environmental Toxicity is a Major Challenge 1 2 3
- 29. Abhijit Sir TheAbhi.in Challenges in Drug Discovery 03 A 2014 global review of pharmaceuticals in the environment, commissioned by Germany’s environment ministry, found that of the 713 pharmaceuticals tested for, 631 were found above their detection limits. Environmental Impact Challenge No# 8
- 30. Abhijit Sir TheAbhi.in Challenges in Drug Discovery 03 1. ALVAC-HIV/AIDSVAX B/E 2. Balovaptan 3. Edasalonexent 4. Elafibranor 5. Epanova 6. Hydroxychloroquine 7. IW-3718 8. SARS-CoV-2 vaccine 9. Semorinemab 10.Tecentriq 2020’s top 10 Clinical trial flops 1. Depatux-M 2. Elenbecestat 3. Emricasan 4. Entresto 5. Fevipiprant 6. Opdivo 7. Pexa-Vec 8. Praliciguat 9. Rapastinel 10.ResVax 11.Rivipansel 12.Rova-T 13.SB-913 14.Selonsertib 15.Toca 511/Toca FC 2019’s top 10 clinical trial flops 1. Atabecestat 2. Axalimogene filolisbac 3. Azeliragon 4. BI 409306 5. EG-1962 6. Epacadostat 7. HTL0018318 8. Ingrezza® 9. Keyzilen® 10.MM-141 11.Olumacostat glasaretil 12.Verubecestat (MK-8931) 13.VR475 2018’s top 10 clinical trial flops Challenge No#9 Clinical trial flops
- 31. Abhijit Sir TheAbhi.in Challenges in Drug Delivery Issues associated with Failure of Drug 04
- 32. Abhijit Sir TheAbhi.in Challenges in Drug Delivery 04
- 33. Abhijit Sir TheAbhi.in Challenges in Drug Delivery 04
- 34. Abhijit Sir TheAbhi.in Challenges in Drug Delivery 04
- 35. Abhijit Sir TheAbhi.in Challenges in Drug Delivery 04
- 36. Abhijit Sir TheAbhi.in Challenges in Drug Delivery 04 Class of therapeutic Challenge Example Small molecules Controlling PK parameters (in particular, half-life, biodistribution, exposure and maximum concentration) Osmotically controlled-release oral-delivery system of methylphenidate HCl (Concerta) to overcome the tolerance of the drug by controlling its PKs215 Improving solubility Ritonavir (Norvir), a protease inhibitor for HIV treatment, thiazole-modified for improved metabolic stability and aqueous solubility13 Improving permeability Benazepril (Lotensin), an alkyl ester prodrug to mask ionizable groups and increase lipophilicity216 Target development Ezetimibe (Zetia), a selective cholesterol-absorption inhibitor discovered through library screening217 Reducing off-target toxicity Naloxegol (Movantik), a PEGylated naloxone derivative to prevent crossing of the blood– brain barrier218 Proteins and peptides Improving physicochemical stability Desmopressin (DDAVP), an analogue of vasopressin with non-natural amino-acid substitution for improved half-life and stability219 Controlling PK parameters (in particular, half-life and biodistribution) Leuprolide acetate for depot suspension (Lupron Depot), a sustained-release microsphere formulation of luteinizing hormone-releasing hormone, providing extended half-life51 Non-invasive administration Insulin human inhalation powder (Afrezza), an inhaled insulin product consisting of microparticles formulated with fumaryl diketopiperazine to achieve suitable characteristics for inhaled delivery220 Bypassing biological barriers Semaglutide (Rybelsus), an oral GLP-1 agonist formulated with SNAC for improved absorption in the stomach46 Reducing immunogenicity Pegademase bovine (Adagen), a PEGylated protein therapy with extended half-life and reduced immunogenicity221 Improving target selectivity Belatacept (Nulojix), a fusion protein with amino acid substitutions for improved selectivity to CD86 and CD80 (ref. 222 )
- 37. Abhijit Sir TheAbhi.in Challenges in Drug Delivery 04 Class of therapeutic Challenge Example Antibodies Controlling PK parameters (in particular, half-life and biodistribution) Certolizumab pegol (Cimza), the first FDA-approved PEGylated antibody fragment, it extends half-life and increases solubility223 Improving physicochemical stability Blinatumomab (Blincyto), a lyophilized antibody with trehalose for improved stability of the antibody structure in the formulation224 Non-invasive administration Trastuzumab and hyaluronidase-oysk (Herceptin Hylecta), a subcutaneous depot with hyaluronidases for the sustained release of Herceptin225 Bypassing biological barriers Trastuzumab and hyaluronidase-oysk225 Reducing immunogenicity Panitumumab (Vectibix), the first FDA-approved fully human antibody, it reduces immunogenicity and prevents the generation of anti-antibodies226 Achieving high-dose requirements Tocilizumab (Actemra), a subcutaneous formulation with excipient, it delivers a high concentration of antibody (180 mg ml−1 )227 Nucleic acids Controlling PK parameters (in particular, half-life and biodistribution) Patisiran (Onpattro), the first FDA-approved siRNA-based therapy, the lipid nanoparticle improves trafficking to the liver and its uptake by target cells198 Improving physicochemical stability Fomivirsen (Vitravene), the first FDA-approved antisense oligonucleotide, incorporates a phosphorothioate backbone modification for improved stability against nucleases228 Bypassing the target-cell membrane Givosiran (Givlaari), a GalNAc–siRNA conjugate for improved uptake in liver hepatocytes229 Accessing the cytosol or nucleus following uptake Patisiran (Onpattro), ionizable cationic lipids mediate endosomal escape following endocytosis198 Reducing immunogenicity Nusinersen (Spinraza), the first FDA-approved therapy for spinal muscular atrophy, the 2′-O-methoxyethyl phosphorothioate modification reduces immunogenicity and improves stability230 Preventing off-target gene editing CRISPR-CCR5-modified CD34+ cells for HIV-1 (NCT03164135); the CD34+ cells are edited ex vivo, and whole-genome sequencing performed after editing and after engraftment detects off-target effects231
- 38. Abhijit Sir TheAbhi.in Challenges in Drug Delivery 04 Class of therapeutic Challenge Example Live-cell therapies Controlling unpredictable PK parameters Preclinical alginate-based biopolymer implants for the controlled release of CAR T cells directly at the site of action204 In vivo persistence and viability SIG-001, factor-VIII-secreting genetically engineered cells in an antifibrotic matrix (NCT04541628); it enables long-term cell persistence at the site of action203 Reducing immunogenicity Fludarabine conditioning chemotherapy for CAR T cells (NCT01865617); conditioning chemotherapy reduces the immune rejection of infused cells232 Maintaining therapeutic-cell phenotype Sipuleucel-T (Provenge), the first FDA-approved cell-based (dendritic cell) immunotherapy, induces and maintains a therapeutic phenotype through ex vivo antigen presentation105 Targeting to disease location Matrix-induced autologous chondrocyte implantation for the maintenance of chondrocytes at the site of action233 , the first FDA-approved cellularized-scaffold product Manufacturing and scale-up Tisagenlecleucel (Kymriah), the first FDA-approved CAR T-cell therapy, established the manufacturing process for genetically engineered autologous cell therapies234
- 39. Abhijit Sir TheAbhi.in Challenges in Drug Delivery 04 Poor Solubility Poor Permeability Poor Bioavailability Poor Drug Absorption Inadequate Distribution Deposition of Drug in Adipose Tissue Stability of the Drug
- 40. Abhijit Sir TheAbhi.in Is there any Solutions? Novel Drug Delivery System
- 41. Abhijit Sir TheAbhi.in Novel Drug Delivery System Issues associated with Failure of Drug 04
- 42. Abhijit Sir TheAbhi.in Novel Drug Delivery System 04 Introduction
- 43. Abhijit Sir TheAbhi.in Novel Drug Delivery System 04 Introduction
- 44. Abhijit Sir TheAbhi.in Novel Drug Delivery System 04 Introduction
- 45. Abhijit Sir TheAbhi.in Novel Drug Delivery System 04 Introduction
- 46. Abhijit Sir TheAbhi.in Novel Drug Delivery System 04 Type of Drug Delivery Systems
- 47. Abhijit Sir TheAbhi.in Novel Drug Delivery System 04 Conventional Vs NDDS
- 48. Abhijit Sir TheAbhi.in Novel Drug Delivery System 04 Conventional Vs NDDS
- 49. Abhijit Sir TheAbhi.in Novel Drug Delivery System 04 Challenges
- 50. Abhijit Sir TheAbhi.in Novel Drug Delivery System 04 Strategies
- 51. Abhijit Sir TheAbhi.in Novel Drug Delivery System 04 Strategies
- 52. Abhijit Sir TheAbhi.in Novel Drug Delivery System 04 Market Size
- 53. Abhijit Sir TheAbhi.in Novel Drug Delivery System 04 Novel Drug Delivery System
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- 75. Abhijit Sir TheAbhi.in Challenges in Drug Delivery 04
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- 84. Abhijit Sir TheAbhi.in THANKS YOU “Keep Learning, Keep Shining” Join me at