Injectable, Ophthalmic, Controlled-Release Solid Orals Considering Regulatory Filing.pptx

Injectable, Ophthalmic, Controlled-Release Solid Orals Considering Regulatory Filing

1. Injectable/Ophthalmic/Controlled-Release Solid Orals Considering Regulatory Filing Dr. Basavaraj K. Nanjwade M. Pharm., PhD. Global Business Development Manager Legis Consultoria Mob#: [phone] E-mail: [email protected] 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 1

2. CONTENTS Injectable Development Ophthalmic Development Controlled-Release Solid Orals Development Regulatory Filing Intellectual Properties Rights 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 2

3. Injectable Development Formulation of a new drug product with excipients, that have been previously added to an approved injectable product. The Physicians' Desk Reference (PDR) and Handbook on Injectable Drugs were reviewed, extracting all information on excipients. 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 3

4. Injectable Types General I njectables Cytotoxic Injectables Freeze Drying Injectables Liquid Injections Powder Injections Beta Lactum Drugs ( I njectables ) Non-Beta Lactam Drugs ( I njectables ) 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 4

5. Injectable Development 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 5

6. Long-Acting Injectable Development Durations of release: 1 week to 1 year Easily syringable with 18- to 23-gauge needle Reconstitutes immediately with sterile water Good stability characteristics Filled asceptically and terminally sterilized if feasible Proven content uniformity Proven free of foreign particulate matter Microsphere-based, biodegradable polymers such as PLA, PLGA, and other polymers with demonstrated low toxicity, and sourced from multiple suppliers Finished dosage form typically consist of a lyophilized vial containing microspheres, a suspending agent and other excipients 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 6

7. 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 7 Long-Acting Injectable Development

8. Ophthalmic Development Ophthalmic or ocular formulations are specialized drug compositions specifically designed and constructed for delivery of drugs to the surface of the eye as an eye drop (a topical instillation ), As an ointment or cream, or for injection into the eye as an intravitreal (IVT) injection.  08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 8

9. Ophthalmic Development S hort-sightedness (myopia) L ong sightedness ( hypermetropia ) A stigmatism Cataracts P ink eye (conjunctivitis) D ry eye disease 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 9

10. Ophthalmic Development 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 10

11. Ophthalmic Development Cyclodextrin -Surfactants & Solubility Enhancing Agents Poloxamer 188-Surfactants & Solubility Enhancing Agents Tween ® 20 ( Polysorbate )- Surfactants & Solubility Enhancing Agents Tween ® 80 ( Polysorbate )- Surfactants & Solubility Enhancing Agents Ethanol 96%-Solvents Glycerol 85%-Solvents Polyethylene glycol (200-600)-Viscosity Enhancers Benzalkonium chloride-Antioxidants & Preservatives Boric acid powder -Antioxidants & Preservatives Boric acid cryst -Antioxidants & Preservatives Magnesium chloride hexahydrate cryst -Tonicity Agents Boric acid cryst - Buffers & pH Modifiers Boric acid powder-Buffers & pH Modifiers 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 11

12. Controlled- Release Solid Orals Oral dosage forms are preferred because of their convenience and cost-effectiveness . R eleasing drugs according to a predictable and rational programed rate to achieve the optimal serum-drug concentration. 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 12

13. Controlled- Release Solid Orals Dissolution Controlled Release System.  Diffusion Controlled Release System Osmotically Controlled Release System . Dissolution and Diffusion Controlled Release System . Ionexchange 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 13

14. Controlled- Release Solid Orals This dosage form enhances the safety, efficacy, reliability, and convenience of drug therapy . Sustained release technology is characterized by the slow releasing of a specific substance at a programmed rate to deliver the drug for a prolonged period of time. This type of technology is used for drugs that are metabolized too quickly and are eliminated from the body shortly after administration. 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 14

15. Controlled- Release Solid Orals Sustained release is a slow release of medication over a period of time, whereas control release releases medication over time in correlation with concentration. Sustained release medication is offered solely by way of oral dosage, while controlled release can be via oral, transdermal administration, or other means. Sustained release technology is first-order kinetic and controlled release technology is zero-order kinetic. 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 15

16. Controlled- Release Solid Orals 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 16

17. Controlled- Release Solid Orals Microcrystalline Cellulose Colloidal Silicon Dioxide, Sodium Starch Glycolate , Sodium Stearyl Fumarate 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 17

18. Regulatory Filing FDA- United States of America EMA- European Union SwissMedic - Switzerland ANVISA- Brazil PMDA-Japan TGA-Australia Health Canada- Canada CDSCO- India 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 18

19. Regulatory Filing Details IND NDA BLA ANDA OTC Covered under FDC Act FDC Act PHS Act FDC Act, Hatch-Waxman Act, BPCIA FDC Act Reviewed by CDER/CBER CDER CBER CBER, OGD CDER(ODE IV) and FTC Listed in Orange book Purple book Orange book OTC Monograph and federal register Type of application Research Marketing Marketing Marketing Marketing Data available/required Preclinical, CMC, proposed CT protocol Clinical , CMC, proposed labelling Clinical , CMC, proposed labelling BA/BE Additionally safety studies, labelling info Types Investigator initiated emergency treatment 5O5(b)(1) 5O5(b)(2) 351(a) Generic-5O5 (j) Biosimilar-351 (k) -- 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 19

20. Regulatory Filing New Chemical Entity/New Molecule Entity (NCE/NME) Generic- Prescription Generics-OTC Biologics Vaccines Orphan Traditional Medicine 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 20

21. Regulatory Filing Regulatory process 5O5(b)(1) 5O5(b)(2) 5O5(j) Review classification/Time line 9 Months 9 Months 6-12 Months New molecular(chemical) entity Yes Yes No New active moiety Yes Yes No New indication Yes Yes No New Route of Administration Yes Yes No New Formulation Yes Yes No New Ester, Salt or Other Non-covalent Derivative Yes Yes No New Dosage Form or Strength Yes Yes No Combination Product Yes Yes May be Rx/OTC Switch Yes Yes No Labelling Yes Yes No 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 21

22. Regulatory Filing Type I DMF : Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable ). Type II DMF: Drug Substance, Drug Substance Intermediate, and Material Used in their Preparation, or Drug Product. Type III DMF: Packaging Material. Type IV DMF : Excipient , Colorant, Flavor , Essence, or Material Used in their Preparation. Type V DMF : FDA Accepted Reference Information . 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 22

23. Regulatory Filing See 21 C.F.R. 314.50       Content and format of an NDA See 21 C.F.R. 314.52       Notice of certification of invalidity, unenforceability, or noninfringement of a patent See 21 C.F.R. 314.53       Submission of patent information See 21 C.F.R. 314.54       Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug  See 21 C.F.R. 314.60       Amendments to an unapproved NDA, supplement, or resubmission See 21 C.F.R. 314.70       Supplements and other changes to an approved NDA See 21 C.F.R. 314.94       Content and format of an ANDA See 21 C.F.R. 314.95       Notice of certification of invalidity, unenforceability, or noninfringement of a patent See 21 C.F.R. 314.96       Amendments to an unapproved ANDA See 21 C.F.R. 314.97       Supplements and other changes to an ANDA See 21 C.F.R. 314.101     Filing an NDA and receiving an ANDA                              See 21 C.F.R. 314.107     Date of approval of a 505(b)(2) application or ANDA See 21 C.F.R. 314.108     New drug product exclusivity See 21 C.F.R. 316.31       Scope of orphan-drug exclusive approval See 21 C.F.R. 316.34       FDA recognition of exclusive approval 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 23

24. Intellectual Properties Rights T he generic company files an Abbreviated New Drug Application (ANDA) and certifies against patents listed in the Orange Book.   If the generic company files an ANDA with a Paragraph IV certification, then the branded company is notified.   After the notice, the branded company has 45 days to file a patent infringement action against the generic company.   08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 24

25. Intellectual Properties Rights Paragraph I certification states that there are no patents listed,  Paragraph II certification states that the listed patents have expired . Paragraph III FDA should approve of its generic version after the date the last patent expires. Paragraph IV that its generic product does not infringe on the listed patents or that those patents are not enforceable. 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 25

26. Intellectual Properties Rights I ntellectual property rights, including patents, trademarks, copyrights, and trade secrets . The five primary requirements for patentability are:  ( 1) Patentable subject matter, ( 2) Utility , ( 3) Novelty , ( 4) N onobviousness , and ( 5) Enablement . 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 26

27. Intellectual Properties Rights Recombinant DNA Recombinant DNA E-Coli Why do we need recombinant DNA Technology Insulin recombinant protein DNA recombinant molecule Recombinant DNA Technology Insert recombinant DNA RDT Genetic Engineering Proteins 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 27

28. References PDA J Pharm Sci Technol. 1997 Jul-Aug;51(4):166-71 . 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 28

29. THANK YOU! Mob# [phone] E-mail: [email protected] 08/6/2023 DKSH India's Pharmaceuticals, Technical Seminar, Bengaluru 29