Patent ES-8501982-A1 (ES)
Title: Stabilised lyophilised interferon compsn.
Filed: 1983-04-18
Abstract: EP--82481 A Compsn. for reconstitution with sterile water comprises (A) interferon, (B) a stabilising amt. of glycine, alpha-alamine or their salts, and (C) a compatible buffer system. Pref. the compsn. comprises 10 power 4 to 5 x 10 power 8 IU of interferon for every 5-150 mg of the aminoacid (or salt); and there is also present up to 10 (pref. ca.1) mg of human albumin for every 5-150 mg of the aminoacid (or salt). The buffer system pref. comprises Na2HPO4 and NaH2PO4, and it pref. maintains a pH of 6.5-8.0 (7.0-7.4), after reconstitution. - The lyophilised formulation is useful in preparing sterile solns., esp. for injections or for use as nasal sprays, nasal solns. or ophtholmic solns. or in the prepn. of ointments, in which interferon is the active drug. Interferon is potentially useful in the treatment various diseases, esp. viral infections. The aminoacid or its salt provides  the lyophilised compsn. with improved stability. Also, it allows lyophilisation to be effected more easily and allows better reconstitution of the lyophilised prod. and better appearance of the prod. (in partic. less colouration). EPAB- EP--82481 B Compsn. for reconstitution with sterile water comprises (A) interferon, (B) a stabilising amt. of glycine, alpha-alamine or their salts, and (C) a compatible buffer system. Pref. the compsn. comprises 10 power 4 to 5 x 10 power 8 IU of interferon for every 5-150 mg of the aminoacid (or salt); and there is also present up to 10 (pref. ca.1) mg of human albumin for every 5-150 mg of the aminoacid (or salt). The buffer system pref. comprises Na2HPO4 and NaH2PO4, and it pref. maintains a pH of 6.5-8.0 (7.0-7.4), after reconstitution. - The lyophilised formulation is useful in preparing sterile solns., esp. for injections or for use as nasal sprays, nasal solns. or ophtholmic solns. or in the prepn. of ointments, in which interferon is the active drug. Interferon is potentially useful in the treatment various diseases, esp. viral infections. The aminoacid or its salt provides  the lyophilised compsn. with improved stability. Also, it allows lyophilisation to be effected more easily and allows better reconstitution of the lyophilised prod. and better appearance of the prod. (in partic. less colouration).  (13pp) - EP--82481 B Compsn. for reconstitution with sterile water comprises (A) interferon, (B) a stabilising amt. of glycine, alpha-alamine or their salts, and (C) a compatible buffer system. Pref. the compsn. comprises 10 power 4 to 5 x 10 power 8 IU of interferon for every 5-150 mg of the aminoacid (or salt); and there is also present up to 10 (pref. ca.1) mg of human albumin for every 5-150 mg of the aminoacid (or salt). The buffer system pref. comprises Na2HPO4 and NaH2PO4, and it pref. maintains a pH of 6.5-8.0 (7.0-7.4), after reconstitution. - The lyophilised formulation is useful in preparing sterile solns., esp. for injections or for use as nasal sprays, nasal solns. or ophthalmic solns. or in the prepn. of ointments, in which interferon is the active drug. Interferon is potentially useful in the treatment various diseases, esp. viral infections. The aminoacid or its salt provides  the lyophilised compsn. with improved stability. Also, it allows lyophilisation to be effected more easily and allows better reconstitution of the lyophilised prod. and better appearance of the prod. (in partic. less colouration).