Patent classifications
A61K47/183
Stabilized Formulations Containing Anti-Interleukin-4 Receptor (IL-4R) Antibodies
The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human interleukin-4 receptor (hIL-4R). The formulations may contain, in addition to an anti-hIL-4R antibody, at least one amino acid, at least one sugar, or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months.
FORMULATION OF AGLYCOSYLATED THERAPEUTIC ANTIBODIES
Described herein are antibody formulations including a therapeutic antibody at a concentration of at least 20 mg/ml, methods for optimizing and producing such antibody formulations, and methods of using such antibody formulations. Antibody formulations including a therapeutic antibody at a concentration of at least about 20 mg/mL are described herein. For example, described are high concentration solutions and formulations of aglycosylated antibod(ies), methods of making such formulations, and methods for using such formulations. The described formulations, when solutions, exhibit reduced viscosity and good stability.
STABLE 5-METHYLTETRAHYDROFOLATE FORMULATIONS TO MODERATE METHYLENETETRAHYDROFOLATE REDUCTASE ASSOCIATED POLYMORPHISMS
Provided herein are methods for preparing stable solutions containing 5-methyltetrahydrofolate (MTHF). Also provided herein are stable compositions containing calcium 5-methyltetrahydrofolate (MTHF-Ca).
Stable Pharmaceutical Solution Formulation of GLP-1R Antibody Fusion Protein
Disclosed is a stable pharmaceutical solution formulation of a GLP-1R antibody fusion protein, comprising a therapeutically effective amount of the GLP-1R antibody fusion protein, an amino acid, a surfactant and a buffer system. The final concentration of the amino acid is 1-500 mM, the final concentration of the surfactant is 0.01%-0.5%, and the pH value of the stable solution formulation is from 5.0 to 8.0. The stable solution formulation of the present invention can be used in the treatment of diabetes, obesity and conditions associated therewith.
STABLE LIQUID FORMULATION FOR MONOCLONAL ANTIBODIES
The present invention concerns stable pharmaceutical compositions for monoclonal antibodies, for example IgG antibodies. The invention further relates to medicaments and treatments using the pharmaceutical compositions of the invention. Additionally, the invention relates to a kit comprising at least one of the pharmaceutical compositions of the invention and a method for reducing aggregation of antibodies.
Stable pharmaceutical composition of vasopressin
The present invention relates to a stable pharmaceutical composition comprising vasopressin or pharmaceutically acceptable salts thereof. The present invention further provides a method of increasing blood pressure in adults with vasodilatory shock by administering said pharmaceutical composition of vasopressin or pharmaceutically acceptable salts thereof.
Insulin premix formulation and product, methods of preparing same, and methods of using same
A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster. The methods for making and using such formulation are also provided. The pharmaceutically acceptable insulin premix formulation may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product. The insulin premix product can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2° C. to 5° C. for 24 months followed by additional 30 days at room temperatures of 23° C. to 27° C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.
Compositions in the form of an injectable aqueous solution comprising amylin, an amylin receptor agonist or an amylin analog, and a co-polyamino acid
An injectable aqueous solution, of which the pH is from 6.0 to 8.0, comprising at least: a) amylin, an amylin receptor agonist or an amylin analog; b) a co-polyamino acid bearing carboxylate charges and hydrophobic radicals Hy, said co-polyamino acid consisting of glutamic or aspartic units and said hydrophobic radicals Hy having the following formula I: ##STR00001## wherein the composition does not comprise a basal insulin of which the isoelectric point pI is from 5.8 to 8.5. It also relates to a composition wherein it moreover comprises a prandial insulin.
LIQUID PHARMACEUTICAL COMPOSITION
The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, arginine and/or methionine, and a small polyol stabiliser such as glycerol. 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.
PROCESS FOR THE PREPARATION OF A COMPOSITION OF LIPOAMINO ACIDS AND DIOLS
Disclosed are a new composition of lipoamino acids and diols, a process for the preparation thereof, and a cosmetic or pharmaceutical composition resulting therefrom.