Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Patent
1984-05-21
1987-04-21
Brown, Johnnie R.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
514 23, 514 54, 514960, 536124, 536127, 536 182, 536 553, 536117, 536 171, A61K 3170, C07H 100
Patent
active
046596992
ABSTRACT:
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 a solution 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 mush 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.
REFERENCES:
patent: 3018302 (1962-01-01), Arnold et al.
patent: 3356652 (1967-12-01), Ray-Chaudhuri
patent: 4157440 (1979-06-01), Reiner et al.
patent: 4404368 (1983-09-01), Alvardo-Urbina et al.
patent: 4537883 (1985-08-01), Alexander et al.
Brown Johnnie R.
Cetus-Ben Venue Therapeutics
Halluin Albert P.
Hasak Janet E.
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