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-
1. Lack of manufacturing capacity.
2. Lack of resource to launch product commercially.
3. Forming alliance with partner.
Importance of technology transfer-
1. To elucidate necessary information to transfer technology from R&D to
production plant.
2. 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-
1. Planning of material requirement
2. Liquid preparation
3. Filling and packaging
4. 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
1. Physical plant.
2. 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
1. Google [Internet]. Google.com. 2021 [cited 27 March 2021]. Available from:
https://www.google.com/
2. An Overview On Technology Transfer Of Pharmaceutical Industry. International
Journal Of Pharmaceutical Sciences And Research. 2020;11(2):573-575.
3. John R. Technology transfer in pharmaceutical industry. The pharma innovation
journal. 2017;6(3):237-238.
4. Bhabani S. Pilot plant scale-up technique. BP 702 T INDUSTRIAL
PHARMACYII (Theory). 2021. p. 11-12.
5. 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.
6. Millili G. Scale-up & Technology Transfer as a Part of Pharmaceutical Quality
Systems. Pharmaceutical Quality system (ICH Q10). Brussels Belgium: WHO;
2011
16

17. 7. 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.
8. 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/Transf
erTechnologyPharmaceuticalManufacturingTRS961Annex7.pdf
9. Subrahmanyam C, Setty J, Sarasija S, Devi V. Pharmaceutical Engineering
principle and practice. Delhi: Vallabh Prakashan; 2001.
10. Production of cough mixture and pharmaceutical syrup. silverson. 2021.
17

18. Thank you…