FIELD: pharmaceutics.
SUBSTANCE: group of inventions relates to a storage-stable soft gelatin capsule, a pharmaceutical composition containing such a capsule, method of its production and method of increasing stability of inner content and/or shell of such capsule. Soft gelatine capsule has an internal content with an active substance selected from diclofenac, diclofenac epolamine (DHEP), tadalafil or pharmaceutically acceptable salts thereof, and the shell of the said capsule contains hydroxypropyl-beta-cyclodextrin (HPBCD) in an amount of (a) less than 10% by weight of the shell weight and (b) a substoichiometric amount to form an inclusion complex with the active substance of the internal content.
EFFECT: disclosed gelatine capsules are stable during storage, prevent formation of by-products from the active substance and have high consistency of weight, id est low hygroscopicity.
13 cl, 2 tbl, 4 ex
Title | Year | Author | Number |
---|---|---|---|
STABLE INJECTABLE PARACETAMOL FORMULATION FOR INJECTIONS | 2011 |
|
RU2519764C1 |
CAPSULES CONTAINING WATER FILLING COMPOSITIONS, STABILISED WITH DERIVATIVE OF CYCLODEXTRIN | 2003 |
|
RU2359698C2 |
PHARMACEUTICAL COMPOSITION AND METHODS FOR USE | 2017 |
|
RU2719450C1 |
METHOD FOR OBTAINING AMORPHOUS CO-EVAPORATES OF CLADRIBIN WITH CYCLODEXTRINS | 2021 |
|
RU2758436C1 |
SUSTAINABLE STRUCTURES OF ANTITHROMBOCYTIC AGENTS, OMEGA-3 FATTY ACIDS AND AMYLOSE IN SOFT GELATIN CAPSULES | 2012 |
|
RU2630606C2 |
PHARMACEUTICAL SOFT GELATIN CAPSULE DOSAGE FORM WITH MODIFIED GUAR GUM | 2014 |
|
RU2676480C2 |
METHOD OF OBTAINING A SOLID FORM OF THE DRUG SEDATIVE AND ANTISPASMODIC ACTION | 2015 |
|
RU2578432C9 |
METHOD OF PREPARING THE COMPLEX OF SILIBININE WITH CYCLODEXTRIN, INCLUSION COMPLEX OF SILIBININE WITH CYCLODEXTRIN, PHARMACEUTICAL COMPOSITION SHOWING ANTIHEPATOTOXIC ACTIVITY AND A METHOD OF ITS PREPARING | 1991 |
|
RU2108109C1 |
STABILISED AMORPHOUS FORMS OF IMANITIB MESYLATE | 2008 |
|
RU2489149C2 |
PERORAL LIQUID COMPOSITIONS | 2000 |
|
RU2252019C2 |
Authors
Dates
2022-03-24—Published
2018-02-09—Filed