Active substance concentrate with formoterol, suitable for storage
AssigneeBoehringer Ingelheim Pharma GmbH & Co. KG
InventorsDieter Hochrainer, Bernd Zierenberg
Life of this patent
Estimating the term…
Abstract
The present invention relates to a formoterol active substance concentrate suitable for storage, in the form of a solution or suspension for use in inhalers for inhalation or nasal therapy.
Claims22
Propellant-free active substance concentrate suitable for storage containing formoterol in the form of its free base, one of the pharmacologically acceptable salts thereof or one of the addition products thereof as the active substance, in a pharmacologically acceptable solvent or suspension agent, wherein the concentration of formoterol is between about 75 mg/ml and about 500 mg/ml.
Active substance concentrate suitable for storage, containing formoterol as active substance, characterised in that formoterol is present as a suspension in water in a concentration of between about 250 mg/ml and about 350 mg/ml and in that the active substance concentrate is adjusted to a pH of about 4.5 to about 5.5 and is in the form of a pharmacologically acceptable salt in an amount such that the formoterol is dissolved to an extent of less than about 0.5% (w/w).
Formulation of a solution for inhalation therapy, containing a solvent mixture of ethanol/water which is adjusted to a pH of about 4.5 to about 5.5, dissolved formoterol in a concentration of about 0.9 to about 1.5 mg/ml based on formoterol, a preservative in a pharmacologically acceptable amount and Na-EDTA in a pharmacologically acceptable amount.
Dependencies are inferred from the claim text.