Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1992-05-20
1995-01-17
Schain, Howard E.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
514 4, 530303, C07K 740, C07K 742, A61K 3726
Patent
active
053825748
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to insulin preparations containing nicotinamide or nicotinic acid or a salt thereof. The preparations exhibit interesting therapeutic properties.
For decades, insulin has been used for the treatment of diabetics. Among the commercially available insulin preparations, rapidly acting, intermediately acting and prolonged acting preparations can be mentioned. Examples of rapidly acting preparations are neutral solutions of zinc containing insulin which, inter alia, are known under the trade marks Actrapid.RTM. and Velosulin.RTM.. Faster absorption of insulin compared to that obtained with the last-mentioned preparations can be effected by using monomeric or dimeric insulin analogs, vide European patent application No. 86306721, or by formulating insulin with magnesium salts, vide European patent application No. 87309229.
According to Diabetic Medicine 6 (1989), 568, diabetic patients have been treated orally with nicotinamide and they have been injected with insulin. The object of the study was to investigate whether small oral doses of nicotinamide would improve metabolic control. In this known study, nicotinamide and insulin was not mixed before administration. A similar study is described in Diabetologia 32 (1989), 160.
A composition for application to the hair and scalp which may contain nicotinamide and/or isophane insulin has been suggested in British patent No. 1,603,639. No compositions containing both nicotinamide and isophane insulin is described therein. This composition is for use in stimulating hair growth and in treating alopecia and excessive hair loss.
BRIEF DISCUSSION OF THIS INVENTION
According to this invention, a preparation containing nicotinamide or nicotinic acid or a salt thereof and insulin or an insulin derivative in solution is made. This preparation may, if desired, furthermore contain precipitated insulin or a precipitated insulin derivative having protracted action. For the purpose of subcutaneous administration, nicotinamide or nicotinic acid or a salt thereof is added in order to obtain a preparation with a more rapid onset of action. If the composition of this invention also contains precipitated insulin or a precipitated insulin derivative, a biphasic preparation may be obtained. Compared with the known biphasic insulin preparations, the biphasic preparations according to this invention have a more rapid onset of blood sugar lowering effect. Examples of precipitated insulin are zinc insulin crystals and protamine zinc insulin crystals.
The preparations of this invention are preferably solutions or suspensions.
Thus, the present invention relates to insulin solutions, optionally containing an insulin precipitate, for parenteral administration (for example, having a pH value in the range of about 3 to about 8.5) and containing nicotinamide or nicotinic acid or a salt thereof.
The concentration of dissolved insulin may be in the range of about 20 to 500 international units (IU) per ml.
Known to the art stabilizers and preservatives may be present in the insulin preparation.
ATTRIBUTES OF THIS INVENTION
Absent retarding substances in the insulin preparations of this invention, the absorption of insulin was surprisingly found to be faster than that of the reference insulin used in the examples below. This property is useful for a rapidly acting insulin, in particular in connection with a multiple injection regimen where insulin is given before each meal. With quicker onset of action, the insulin can conveniently be taken closer to the meal than with conventional rapidly acting insulin solutions. Furthermore, a faster disappearance of insulin probably diminishes the risk of post meal hypoglycemia.
The preparations of this invention are believed to be well suited for application in fountain pen like devices used for multiple injection insulin therapy.
DISCUSSION OF THIS INVENTION
The preparations of this invention may contain a naturally occurring insulin and/or an insulin derivative. Preferred insulins for practice of this invention are human i
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patent: 4971951 (1990-11-01), Bellon et al.
patent: 5155096 (1992-10-01), Bellon et al.
Lowney Karen A.
Novo Nordisk A S
Schain Howard E.
Zelson Steve T.
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