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EP0251657A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Therapeutic compositions with galactitol as carrier

Assignee: Cetus Ben Venue Therapeutics
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Filing: 1987-06-23
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Granted: —
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Expires: 2007-06-23
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Abstract

Abstract An improved pharmaceutical or veterinary composition contains galactitol as carrier for the therapeutic agent. Preferred therapeutic agents include anti-infective and anti-cancer drugs, preferably cytotoxic agents and lymphokines. One example is a lyophilized composition of about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 5 to 21 parts by weight of galactitol as excipient, and about 1.4 to 3 parts by weight of water. Preferably, the amount of galactitol is 15-21 parts by weight. The galactitol enhances the chemical and physical stability of the drug and allows faster reconstitution of the formulation in water than mannitol.

Inventors

  • 👤 Daniel Lee Francis

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-23 10:24
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/14; A61K9/19; A61K31/00; A61K31/66; A61K31/675; A61K47/00; A61K47/06; A61K47/26; A61K47/30; A61K47/36; A61K9/0012; A61K9/0019; A61P; A61P35/00; C; C07; C07F; C07F9/00; C07F9/02; C07F9/547; C07F9/6564; C07F9/6581; C07F9/6584; C07F9/65842; C07F9/65846; F; F26; F26B; F26B5/00; F26B5/04; F26B5/06

Claims Analysis

Total Claims: 16
Claim 1
Independent Claim 15 words
A pharmaceutical or veterinary composition comprising a therapeutic agent and a carrier predominantly comprising galactitol.
Claim 2
Dependent Claim 15 words
A pharmaceutical or veterinary composition comprising a therapeutic agent and a carrier predominantly comprising galactitol.
Claim 3
Dependent Claim 17 words
A composition of claim 1 wherein said therapeutic agent is an anit-infective agent or an anti-cancer drug.
Claim 4
Dependent Claim 16 words
A composition of claim 2 wherein said therapeutic agent is a lymphokine or a cytotoxic agent.
Claim 5
Dependent Claim 50 words
A composition of claim 3 wherein said lymphokine is interleukin-2, colony stimulating factor-1, G-colony stimulating factor, or GM-colony stimulating factor, or said cytotoxic agent is interferon-α , interferon-β , interferon-γ , tumor necrosis factor, an immunotoxin, cyclophosphamide, methotrexate, vincristine, 5-fluorouracil, cystosine arabinoside, vinblastine, bleomycin, doxorubicin hydrochloride, mitomycin-C, daunorubicin, or cisplatin.
Claim 6
Dependent Claim 19 words
A composition of claim 4 wherein said cytotoxic agent is cyclophosphamide and the composition further comprises a water diluent.
Claim 7
Dependent Claim 33 words
A composition of any one of claims 1 to 5 wherein the ratio of galactitol to therapeutic agent ranges from about 1:0.1 to 1.05:1, depending on the solubility properties of said therapeutic agent.
Claim 8
Dependent Claim 46 words
A hydrated lyophilizate composition, having enhanced chemical and physical stability and uniform appearance and consistency, comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 5 to 21 parts by weight of galactitol, and about 1.4 to 3 parts by weight of water.
Claim 9
Dependent Claim 46 words
A hydrated lyophilizate composition, having enhanced chemical and physical stability and uniform appearance and consistency, comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 5 to 21 parts by weight of galactitol, and about 1.4 to 3 parts by weight of water.
Claim 10
Dependent Claim 18 words
A composition of claim 7 wherein the amount of galactitol is about 15 to 21 parts by weight.
Claim 11
Dependent Claim 22 words
A composition of claim 7 or claim 8 wherein no more than 49% by weight of the galactitol is replaced with mannitol.
Claim 12
Dependent Claim 11 words
The use of galactitol as a carrier for a therapeutic agent.
Claim 13
Dependent Claim 11 words
The use of galactitol as a carrier for a therapeutic agent.
Claim 14
Independent Claim 16 words
A method for making a therapeutic composition which includes the incorporation of galactitol as a carrier.
Claim 15
Independent Claim 16 words
A method for making a therapeutic composition which includes the incorporation of galactitol as a carrier.
Claim 16
Dependent Claim 25 words
A method of claim 11 and further defined by the specific composition feature or features of any one or more of claims 2 to 9.

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