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Liquid pharmaceutical composition

A liquid drug and composition technology, applied in drug combination, drug delivery, antibody, etc., can solve problems such as adverse interactions, damage to preparations, increased process and cost burden

Inactive Publication Date: 2017-12-05
FRESENIUS KABI DEUT GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

While this particular combination of excipients undoubtedly represents a "delicate balance" (given the interplay between various technical factors) and is the result of extensive research and risk, it is debatable whether such a large number of different excipients is required, especially given that such a large number of different excipients inevitably increases process and cost burdens, toxicity risks, and interactions between components that can destroy the formulation. risk of adverse interactions

Method used

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  • Liquid pharmaceutical composition
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Examples

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specific Embodiment

[0266] In certain embodiments, the liquid pharmaceutical composition comprises adalimumab and any one of the combinations of components 1, 2, and / or 3 listed in Table A below. In embodiments in which one or more components are left blank, the composition should be considered to require only those actually listed in components 1, 2, and / or 3, but it should be understood that these embodiments do not necessarily Compositions containing components not listed are excluded. For example, Example A.4 requires that the pharmaceutical composition comprises a PVP surfactant and a monocyclic sugar stabilizer, but not necessarily component 3.

[0267] Table A - Various examples of liquid pharmaceutical compositions comprising adalimumab in any combination with any of the listed components Example (A.1-A.25)

[0268]

[0269]

[0270] "PVP surfactant" = general PVP surfactant; "monocyclic SS" = general monocyclic sugar stabilizer; "metal carboxylic acid" = general metal (hydro...

Embodiment

[3104] Stability studies performed on various liquid adalimumab formulations helped the inventors to identify some key parameters affecting the stability of adalimumab formulations, especially the stability of adalimumab itself. Such stability studies typically involve exposing the formulation to stress (eg heat, light, agitation, long term storage) and making appropriate time course measurements (ie before and after stress). For example, a bioanalyzer is commonly used for purity measurement; DSF is commonly used to measure development temperature; iCE280 is used to obtain isoform profiles; OD is used to assess protein content; SE-HPLC is used to determine protein aggregation; Other measurements, such as pH and osmolality, are made by known methods.

[3105] Based on the results of these stability studies, several formulations were selected as promising candidates for further study, including those shown in Table 1 below:

[3106] Table 1 - Promising candidate formulations ...

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Abstract

The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, and at least one component selected from the group consisting of: a polyvinylpyrrolidone (PVP) surfactant, an inositol sugar stabiliser, and a gluconate salt toncifier. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.

Description

technical field [0001] The present invention relates to a novel protein preparation. In particular, the present invention relates to liquid pharmaceutical compositions comprising adalimumab, methods of preparing said compositions, kits comprising said compositions, packages comprising said compositions, manufacturing said packages Products, and methods of treatment using the compositions and / or packaged products. Background technique [0002] By using FDA-approved drugs such as adalimumab ( Abbott Corporation, for the treatment of autoimmune diseases associated with tumor necrosis factor-α (TNF-α), such as rheumatoid arthritis, psoriasis, and other autoimmune diseases. Adalimumab is a human monoclonal antibody that inhibits the activity of human TNF-α to prevent its activation of TNF receptors, thereby down-regulating inflammatory responses associated with autoimmune diseases. Approved medical indications for adalimumab include: rheumatoid arthritis, psoriatic arthritis,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/32A61K47/26A61K47/12A61K39/395A61P29/00A61P19/02A61P17/06A61P37/00
CPCA61K9/0019A61K9/08A61K47/12A61K47/26A61K47/32C07K16/24A61K2039/505A61K47/08A61P1/04A61P17/06A61P19/00A61P19/02A61P29/00A61P37/00A61K39/39591A61K47/02A61K2039/54C07K16/241
Inventor G·里纳尔迪S·弗拉塔坎杰里A·德尔 里奥
Owner FRESENIUS KABI DEUT GMBH
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