Pharmaceutical formulation
AssigneeBoehringer Ingelheim International GmbH
InventorsDetlef MOHR, Florian SOMMER
Life of this patent
Estimating the term…
Abstract
The present invention relates to pharmaceutical formulations of highly active drugs with limited shelf-life in aqueous media, suitable to be administered by a caregiver person to a patient avoiding or minimizing the risk of exposure, contact or contamination of the caregiver person with the active product ingredient (API), preferably an EGFR-TKI such as afatinib dimaleate.
Claims17
A pharmaceutical kit comprising
- (i) at least one water-soluble pharmaceutical capsule containing a powder formulation of a drug comprising an active pharmaceutical ingredient (API) susceptible to hydrolytic decomposition,
- (ii) 50 to 250 ml of a suitable pharmaceutically acceptable solvent as a reconstitution medium contained in a pharmaceutically acceptable container 5 to 300% oversized by volume, for preparation of an oral solution comprising the API ready for administration with a shelf-life of the oral solution of up to 6 months at ambient temperature, and, optionally
- (iii) an oral syringe of suitable volume and graduation which can be connected with the bottle via an adapter plug, for dosing and administration,
- and, optionally,
- (iv) handling instructions comprising preparation of the oral API solution, measurement, withdrawal and administration of a dose.
A pharmaceutically acceptable solvent comprising the combination of the following four taste masking principles
- (1) a pharmaceutically acceptable acid,
- (2) a pharmaceutically acceptable sweetener,
- (3) a pharmaceutically acceptable salt and
- (4) a pharmaceutically acceptable flavor.
A method of administering a water-soluble pharmaceutical capsule containing a powder formulation of a drug comprising an API susceptible to hydrolytic decomposition to a patient who cannot swallow tablets, comprising
- dissolving the water-soluble capsule in 50 to 250 ml of a suitable pharmaceutically acceptable solvent as a reconstitution medium contained in a pharmaceutically acceptable container 5 to 300% oversized by volume,
- obtaining a defined dosage by withdrawing the required volume of the oral solution from the bottle using an oral syringe of suitable volume and graduation to be connected with the bottle via an adapter plug, and
- administering the defined dosage from the syringe orally to the patient.
A process for preparing a pharmaceutically acceptable solvent as a reconstitution medium for preparation of an oral solution of a drug ready for administration, comprising the steps of:
- successively dissolving the following four taste masking principles
- (1) a pharmaceutically acceptable acid,
- (2) a pharmaceutically acceptable sweetener,
- (3) a pharmaceutically acceptable salt and
- (4) a pharmaceutically acceptable flavor
- in purified water,
- adjusting to final weight by addition of purified water to obtain a bulk solution,
- optionally filtering the bulk solution, and
- optionally filling the bulk solution in a pharmaceutically acceptable container.
Dependencies are inferred from the claim text.