1. LYOPHILIZATION TECHNIQUE: OVERVIEW

2. CONTENT Introduction Advantage Disadvantage Lyophilization cycle
Lyophilization equipment
Lyophilization container requirement
Process to Produce a product that “Love Dry State”
Typical Lyophilization Process
Design of Lyofreezer
Excipients used in Lyophilized Formulation
Annealing
Applications of Lyophilization Technology
Conclusion
References

3. INTRODUCTION Lyophilization means freeze drying.
The term “lyophilization” describes a process to produce a product that “loves the dry state”.
This process comprises three steps: freezing, primary drying, and secondary drying.
The most common form of sterile parenteral powder is freeze dried or lyophilized powder.

4. ADVANTAGE:- Economic Safe Good stability Long shelf life
High activity rate
Low moisture
Rapid rehydration

5. DISADVANTAGES:– More complicated development.
More expensive manufacturing
Specialized capabilities required increased handling and processing time.
Volatile compounds may be removed by vacuum.

6. LYOPHILIZATION CYCLE Step1]:- Sample Preparation Step2]:- Freezing
Step3]:- Primary drying
Step4]:- Secondary drying
Step5]:- Final Product

7. LYOPHILIZATION EQUIPMENT:-
There are essentially three categories of freeze dryers:
Manifold freeze-dryer
Rotary freeze dryer
Tray style freeze-dryer

8. LYOPHILIZATION CONTAINER REQUIREMENTS
Thermal conductivity
Minimize the moisture
Tight sealing

9. PROCESS TO PRODUCE A PRODUCT THAT “LOVES DRY STATE”
This technique widely used for pharmaceuticals to improve stability and long term storage of labile drugs.
Lyophilization or Freeze-drying fills an important need in pharmaceutical manufacturing technology .
The most common application of pharmaceutical freeze drying is in the production of injectable dosage forms.
This process is also used in the production of diagnostics .

10. TYPICAL LYOPHILIZATION PROCESS
The first step that takes place in lyophilization process is component preparation i.e. the sterile solution should be prepared, compound, mixed, filtered.
The filtered solution is filled into containers (vials). Partially insert a special designed rubber closure onto the vials.
Aseptically load the vials into a freeze dry chamber.
Freeze every single solution in every vial below a pre-determine critical temperature.
Using appropriate application of temperature and pressure, sublime the ice from the product.

11. Powder
Solution

12. DESIGN OF LYOFREEZER
Fig: Lyofreezer

13. The Essential Components of lyofreezer include:-
Chamber
Shelves
Process condenser
Shelf fluid system
Refrigeration system
Vaccum system
Sensors
Control system

14. EXCIPIENTS USED IN LYOPHILIZED FORMULATION
The design of a lyophilized formulation is dependent on the requirements of the active pharmaceutical ingredient (API) and intended route of administration.
A formulation may consist of one or more excipients that perform one or more functions.
Excipients for lyophilization usually fit one of the following categories:
1] Bulking agents
2] Stabilizers
3] Buffering agents
4] Tonicity modifiers, surface-active agents
5] Collapse temperature modifiers
6] Antimicrobial product

15. Annealing
Annealing is an additional step involved in freeze drying process which will help to accelerate primary drying.
This process involve holding the product at a temperature for defind period.
Annealing reduced primary drying rate.

16. APPLICATIONS OF LYOPHILIZATION TECHNOLOGY
Industrial applications:
1] Pharmaceutical industry:
2] Food industry:
3] Other industries:

17. CONCLUSION
Lyophilization (freeze-drying) is often used to prepare dry pharmaceutical formulations to achieve commercially viable shelf lives.
The process comprises three steps: freezing, primary drying, and secondary drying.
Under appropriate lyophilization conditions, the ice is removed by sublimation during primary drying.
Residual water in the freeze concentrate is removed in the secondary drying step.
The knowledge of how to control, or at least manipulate, the freezing step will help to develop more efficient lyophilization cycles and biopharmaceutical products with an improved stability.

18. REFERENCES
Akers MJ, Fites AL, Robinson RL. Types of parenteral administration. Journal of parenteral science and Technology, 1987, 41,
Lapincolt, Williams K. Remington, The Science & practice of pharmacy, Parenteral Preparation, 20th ed, ISE publication, Phelabelphia. 2000, 1,
S.L. Nail, “The Effect of Chamber Pressure on HeatTransfer in the Freeze Drying of Parenteral Solutions,” PDA J. Pharm. Sci. Technol. 34,358–368 (1980).
M.J. Pikal et al., “Physical Chemistry of Freeze-Drying: Measurement of Sublimation Rates for Frozen Aqueous Solutions by a Microbalance Technique,” J. Pharm. Sci. 72, 635–650 (1983).

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