A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
167/264
A61K 31/675 (2006.01) A61K 9/19 (2006.01) A61K 47/26 (2006.01) A61K 47/36 (2006.01) C07F 9/6584 (2006.01) F26B 5/06 (2006.01)
Patent
CA 1215649
PROCESS FOR FREEZE DRYING CYCLOPHOSPHAMIDE ABSTRACT OF THE DISCLOSURE A two-stage process for freeze-drying an aqueous solution of a dosage amount of cyclophosphamide to yield a hydrate of cyclophosphamide (referred to as "CPA" for brevity), comprises, in a first stage, freeze-drying asolution of CPA in combination with an excipient until the moisture content of the freeze-dried material is less than 2% by wt, based on the amount of anhydrous CPA present; and, in a second stage, rehydrating the freeze-dried material until the moisture content of the product is in the critical range of from about 2% to 7% by wt, based on the net wt of CPA product, it being essential for stability of the product that at least one sugar excipient be present. The process requires that a major amount by weight of the excipient(s) or all of it, be mannitol, optionally with an additional sugar and/or a carboxylic acid, and/or a buffer salt; and, the mannitol is present in an amount at least one-half (0.5 times) as much as the CPA (anhyd) present. To produce a dosage form of a 'plug' or 'cake' which is free of flakes and granules, or bubbles on its surface, and/or voids within the product (or "plug"), any of which are individually no greater than 2 mm in equivalent diameter ("equiv. dia."), requires a unique combination of carefully controlled process steps. The preferred CPA product obtained by the process provides a dosage amount of stable freeze-dried and rehydrated CPA as a hydrate which includes at least an equivalent amount by weight, and up to 5 times as much, of mannitol. The dosage amount may include sodium chloride to adjust tonicity, and a buffer salt to maintain pH.
457672
Cetus-Ben Venue Therapeutics A. Partnership
Gowling Lafleur Henderson Llp
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