Hi,

Go through attached article.

Hi,

  First thing to go about lyophilization cycle development you need to generate few basic datas to design a cycle.

- You need to determine the collapse temperature of the mixture (DSC, Freeze dry microscope etc).

- It is better to have a fill depth less than 1.5 cm so choose you vial size accordingly.

- Freeze the product below the collapse temperature for atleast 2-3 hours and start drying under vacuum.

- The chamber pressure to be set should be less than (preferably 1/3rd) the icevapour pressure.

For eg if your collapse termperature is -30°C. Freeze you product to -40°C for 2-3 hours. Start drying with shelf temperature as - 25°C and have chamber pressure as 75 mTorr anticipitating the product temperature during would be around -30°C (icevapour pressure at -30°C 285 mTorr).

Continue the primary drying until your product temperature and shelf temperature becomes same and further increase the shelf temperature to get a dry product but until the above said process your product should dry at temperature lower than collapse temperature.

Regarsing the reconstitution the same volume you used to disperse the drug can be used. you might observe a faster dissolution or reconstitution but it might not enhance the solubility to a greater extent.  

Thanks to all for answer and suggest a literature.