Lyophilized pharmaceutical composition of neocarzinostatin deriv

Synthetic resins or natural rubbers -- part of the class 520 ser – Synthetic resins – Mixing of two or more solid polymers; mixing of solid...

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524 54, 524 56, 524 58, 514777, 514778, C08G 6348, C08G 6391, C08L 8900, A01N 2500

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active

050267728

ABSTRACT:
A lyophilized pharmaceutical composition comprised of a neocarzinostatin derivative having the formula (SMA)-(NCS)-(SMA), is made by a method including dissolving the neocarzinostatin derivative and stabilizing agent comprising at least one saccharide selected from the group consisting of monosaccharides, disaccharides and dextran in an aqueous buffer solution having a pH ranging from about 7.5 to about 9.5, the stabilizing agent being present in an amount by weight (titer) which is at least equal to that of the neocarzinostatin derivative, to provide a solution; adjusting the pH of the solution to provide a pH-adjusted solution having a pH of about 8.0.+-.0.5; sterilizing the pH-adjusted solution by filtration to provide a sterilized solution; and lyophilizing the sterilized solution.

REFERENCES:
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patent: 4182752 (1980-01-01), Maeda et al.
patent: 4457916 (1984-07-01), Hayashi et al.
patent: 4714611 (1987-12-01), Yasaburgo et al.
patent: 4732933 (1988-03-01), Maeda et al.
Chemical Abstracts, vol. 85, No. 22, Nov. 29th, 1976, p. 449, abstract No. 166665a.
Chemical Abstracts, vol. 93, No. 1, Jul. 7th, 1980, p. 317, abstact No. 13083z.
Chemical Abstracts, vol. 105, No. 9, Nov. 10th, 1986, p. 371, abstract No. 178320d.
Kohno, M., et al., "Studies on the Stability of Antitumor Protein, Neocarzinostatin", The Japanese Journal of Antibiotics, vol. XXVII, No. 6, Dec. 1974, p. 714, (English-Language Abstract).

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