|Title:||Pharmaceutical formulation of human-growth hormone pretreated with zinc salt|
|Abstract:||A pharmaceutical formulation comprising a growth hormone pretreated with zinc and optionally lysine or calcium ions shows a very high stability against deamidation, oxidation and cleavage of peptide bonds. The stability of the product allows for the storing and shipment thereof in a lyophilized state or in the form of a dissolved or re-dissolved formulation at ambient temperature.|
|Inventor(s):||S.o slashed.rensen; Hans Holmegaard (Virum, DK), Olsen; Ole Hvilsted (Br.o slashed.nsh.o slashed.j, DK), Thim; Lars (Gentofte, DK), Thorkild; Christensen (Aller.o slashed.d, DK), Balschmidt; Per (Esperg.ae butted.rde, DK)|
|Assignee:||Novo Nordisk A/S (Bagsvaerd, DK)|
|Filing Date:||Jul 23, 1998|
|Claims:||1. A pharmaceutical formulation comprising a human growth hormone pretreated with zinc salt for at least one hour before addition of other components to the formulation and optionally containing lysine or calcium ion. |
2. The formulation according to claim 1, futher comprising a buffered aqueous solution.
3. The formulation according to claim 1, wherein said formulation has a pH between about 2 to about 9.
4. The formulation according to claim 1, wherein the concentration of zinc salt is between about 0.01-2 mM.
5. The formulation according to claim 1, further comprising salt and saccharide.
6. A method of preparing the pharmaceutical formulation according to claim 1, comprising (a) dissolving growth hormone in a solution comprising zinc chloride and optionally lysine or calcium ions, (b) letting the solution of (a) stand for at least one hour, (c) adding benzyl alcohol to the solution of step (b) and (d) optionally adjusting the pH to from about 2 to about 9.
7. The method according to claim 6, which further comprises after step (b) and before step (c) subjecting the solution of step (b) to gel filtration chromatography.
8. The method according to claim 6, further comprising adding salts and an excipient, filling the solution into a container and lyophilizing said solution.
9. A method for treating a patient having a disorder affectable by growth hormone deficiency, comprising administering to said patient the formulation of claim 1.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.