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Practical aspects of lyophilization using non-aqueous co-solvent systems.

INTRODUCTION
Freeze-drying of pharmaceutical and biological solutions to produce an elegant
stable powder has been a standard practice employed to manufacture many
marketed pharmaceutical and biological products for over 50 years. The vast
majority of these products are lyophilized from simple aqueous solutions. Water
is typically the only solvent of significant quantity that is present, which must be
removed from the solution via the freeze-drying process. However, frozen water
(ice) is not the only frozen liquid that can sublime under reduced pressures.
Numerous organic and mineral solvents have been shown to possess this
property (1). It is also noteworthy that during the freeze-drying of pharmaceutical or biological products it is not unusual for small quantities of organic
solvents to be present in either the active pharmaceutical ingredient or one of the
excipients. These low levels of organic solvent are commonly found because
they may be carried through as part of the manufacture of these individual
components since the ingredient may be precipitated, crystallized, or spray
dried from organic solvents. Therefore, many freeze-dried products may be
dried from solutions, which contain low levels of a variety of organic solvents.
Additionally, there may be instances where freeze-drying from substantial
quantities of organic solvents or mixtures of water and organic solvent may offer
the formulation scientist advantages over simply drying from an aqueous
solution. An example of at least one pharmaceutical product on the market that
has utilized an organic cosolvent system during freeze-drying is CAVERJECT1Sterile Powder (2,3). This particular product has been successfully manufactured
by freeze-drying from a 20% vol/vol tert-butanol/water cosolvent system.
Another example is the anticancer drug Imexon. This drug, which is undergoing
clinical testing, utilized dimethyl sulfoxide (DMSO) as a formulation vehicle
prior to lyophilization (4).

Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Nonaqueous Cosolvent Systems

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Practical aspects of lyophilization using non-aqueous co-solvent systems.

Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Nonaqueous Cosolvent Systems