Technology transfer of liquid orals

Technology transfer in liquid orals and SUPAC guidelines for liquid orals. scale-up techniques for liquid orals. pilot plant scale-up of liquid orals.

1. Technology transfer from R&D to pilot plant to plant for liquid orals. Department of Pharmaceutics S.T.E.S.’s Smt. Kashibai Navale College of Pharmacy, Kondhwa (BK), Pune- 411048 Presented By- Mr. Ashish Dilip Sutar M.Pharm (sem-I) Guided By- Ms. Dyandevi mathure (Assistant Professor, Dept. of Pharmaceutics) 1

2. FLOW OF PRESENTATION SIGNIFICANCE AND IMPORTANCE OF TECHNOLOGY TRANSFER ↓ DOCUMENTATION INVOLVED ↓ SCALE UP CONSIDERATION OF ORAL LIQUID DOSAGE FORM ↓ CASE STUDY ↓ REFERANCES 2

3. Definition Technology transfer- It is victorious step from R&D to full scale industry. Plant- Is place where 5M are brought together - Money, Material, Man, Method, Machine. Pilot plat- It is place where a lab scale formula transferred into viable product. Scale up- The art of designing of prototype using data obtained from pilot plant. Reference - Google [Internet]. Google.com . 2021 [cited 27 March 2021]. Available from: https:// www.google.com / 3

4. Reason of technology transfer- Lack of manufacturing capacity. Lack of resource to launch product commercially. Forming alliance with partner. Importance of technology transfer- To elucidate necessary information to transfer technology from R&D to production plant. To elucidate necessary information to transfer technology of existing product between various manufacturing places. Reference - An Overview On Technology Transfer Of Pharmaceutical Industry. International Journal Of Pharmaceutical Sciences And Research. 2020;11(2):573-575. 4

5. Documentation required for technology transfer- R&D provides technology transfer dossier (TTD) document to a product development laboratory that contain Master formula card Master packaging card Master formula STP (standard test procedure) Reference - John R. Technology transfer in pharmaceutical industry. The pharma innovation journal. 2017;6(3):237-238. 5

6. Pilot plant scale up consideration for liquid oral formulation. Liquid oral dosage form- Solution Dispersed system. Steps involved in liquid oral manufacturing process- Planning of material requirement Liquid preparation Filling and packaging Quality assurance Reference - Bhabani S. Pilot plant scale-up technique. BP 702 T INDUSTRIAL PHARMACYII (Theory). 2021. p. 11. 6

7. General flow chart of liquid oral’s manufacturing RAW MATERIAL MEASURED AND WEIGHED MIXING FILLING PACKING DISTILLED WATER FINISHED PRODUCT STORAGE QUALITY ASSURANCE QC TEST Reference -Lachman, L., Liebermann, H. and Kanig , J., 1987.  The Theory and practice of industrial pharmacy . 3rd ed. Dadar Bombay: Varghese publishing house, pp.703-708. 7

8. Critical aspects of liquid oral’s manufacturing Physical plant. Heating ventilation and air controlling system. Reference - Millili G. Scale-up & Technology Transfer as a Part of Pharmaceutical Quality Systems. Pharmaceutical Quality system (ICH Q10). Brussels Belgium: WHO; 2011. 8

9. Parameters to be considered for scale up of solution. Impeller (Type, Diameter, Speed) Tank (size and material) (inertness of steel) Baffle's Transfer system Height of filled volume in tank Stand Reference - Torotwa I, Ji C. A Study of the Mixing Performance of Different Impeller Designs in Stirred Vessels Using Computational Fluid Dynamics. Designs. 2018;2(1):Figure 1. 9

10. Parameters to be considered for scale up of suspension. Versator and Deaerator Wetting and suspending agent Addition of ingredients and suspending agents Selection of equipment according to batch size Reference - WHO guidelines on transfer of technology in pharmaceutical manufacturing [Internet]. Who.int . 2011 [cited 27 March 2021]. 10

11. Parameters to be considered for scale up of emulsion. Homogenizing equipment Temperature Mixing equipment Phase volume Reference - Subrahmanyam C, Setty J, Sarasija S, Devi V. Pharmaceutical Engineering principle and practice. Delhi: Vallabh Prakashan ; 2001. 11

12. Time gap between two successive batches Production rate Space requirement Filtration equipment Filling equipment Common parameters to be considered for scale up of liquid oral dosage form . Reference - Google [Internet]. Google.com. 2021 [cited 27 March 2021]. Available from: https://www.google.com/ 12

13. Case study- Production of cough mixture and pharmaceutical syrup. Traditional cough mixture- formulated around a syrup 60-75% conc. of sucrose, glucose etc. + remaining is thickening agent, stabilizer & active ingredient. Problems- No proper dissolution Crystallization of syrup Damage of active ingredient due to heat Formation of agglomerates Reference - Production of cough mixture and pharmaceutical syrup. Silverson . 2021. 13

14. To be continued Method to overcome problem’s and to perform successful scale-up. Use Silverson high shear mixer- suitable for batch size of 3000 Liters, avoid air entrapment and contamination. 3 stages for mixing in Silverson high shear mixer- 1 3 2 ↓ ↓ Reference - Production of cough mixture and pharmaceutical syrup. Silverson . 2021. 14

15. Conclusion. Traditional method’s of manufacturing limited to lab scale. Main problem- Mixing To overcome this various problems we need- modification and upgradation in procedure and equipment. 15

16. Reference Google [Internet]. Google.com. 2021 [cited 27 March 2021]. Available from: https://www.google.com/ An Overview On Technology Transfer Of Pharmaceutical Industry. International Journal Of Pharmaceutical Sciences And Research. 2020;11(2):573-575. John R. Technology transfer in pharmaceutical industry. The pharma innovation journal. 2017;6(3):237-238. Bhabani S. Pilot plant scale-up technique. BP 702 T INDUSTRIAL PHARMACYII (Theory). 2021. p. 11-12. Lachman, L., Liebermann, H. and Kanig , J., 1987.  The Theory and practice of industrial pharmacy . 3rd ed. Dadar Bombay: Varghese publishing house, pp.703-708. Millili G. Scale-up & Technology Transfer as a Part of Pharmaceutical Quality Systems. Pharmaceutical Quality system (ICH Q10). Brussels Belgium: WHO; 2011 16

17. Torotwa I, Ji C. A Study of the Mixing Performance of Different Impeller Designs in Stirred Vessels Using Computational Fluid Dynamics. Designs. 2018;2(1):Figure 1. WHO guidelines on transfer of technology in pharmaceutical manufacturing [Internet]. Who.int . 2011 [cited 27 March 2021]. Available from: https:// www.who.int /medicines/areas/ quality_safety / quality_assurance /TransferTechnologyPharmaceuticalManufacturingTRS961Annex7.pdf Subrahmanyam C, Setty J, Sarasija S, Devi V. Pharmaceutical Engineering principle and practice. Delhi: Vallabh Prakashan ; 2001. Production of cough mixture and pharmaceutical syrup. silverson . 2021. 17

18. Thank you…