302results about "Lyophilised delivery" patented technology

The present disclosure provides daptomycin formulations which have improved chemical stability, faster reconstitution times when reconstituted from the solid state and longer in-use stability. The compositions comprise daptomycin, one basic amino acid or its salt and optionally one or more pH adjusting agents.

The present disclosure provides a formulation of an IL-12-albumin binding domain (ABD) fusion protein comprising a fusion protein of about 10 μg / mL to about 50 μg / mL, about 25 mM to about 100 mM alanine, about 100 mM to about 400 mM trehalose, about 10 mM to about 50 mM glycylglycine, about 0.01% to about 0.04% polysorbate 20 (v / v), and about 5 μM to about 20 μM diethylenetriaminepentaacetic acid (DTPA), and the formulation has a pH of about 6.8 to about 8.0. Such a formulation may be useful for treating and / or preventing an IL-12 related disease or disorder in a subject in need of treatment of an IL-12 related disease or disorder.

This application relates to a pharmaceutical composition of an aquaporin inhibitor and a method for producing the same. The pharmaceutical composition comprises 2-((3,5-bis(trifluoromethyl)phenyl)carbamoyl)-4-chlorophenyl dihydrogen phosphate or a pharmaceutically acceptable salt thereof, or a pharmaceutically acceptable solvate thereof, and meglumine. The pharmaceutical composition of an aquaporin inhibitor and a method for producing the same have the following advantages: the process is simple, easy to operate, conducive to industrial production, good product stability, and a significantly reduced content of degradable impurities, which ensures pharmaceutical efficacy.

Disclosed are a peptide amide compound composition, a preparation method therefor and medical use thereof. Specifically, the composition contains a compound of formula (I) and pH regulators, and the pH of the solution thereof is 3-5.5. The composition is stable and requires few excipients, and is stable in clinical use.

The present invention relates to the use of a therapeutic agent based on cell wall fragments of a virulent strain of Mycobacterium tuberculosis-complex for the preparation of a drug for the treatment of patients with active tuberculosis.

This invention provides the application of Liu Mo Tang freeze-dried powder in the preparation of products regulating intestinal flora imbalance, belonging to the field of biomedical technology. The Liu Mo Tang freeze-dried powder provided by this invention effectively improves intestinal flora imbalance, particularly in constipation-predominant irritable bowel syndrome (IBS). Constipation-predominant IBS leads to a decrease in butyrate-producing bacteria, reduced butyrate production capacity, impaired intestinal barrier function, increased permeability, and weakened intestinal motility, accompanied by pathogenic bacterial proliferation. After administration of Liu Mo Tang, the abundance of butyrate-producing bacteria is upregulated, and the increase of abnormal bacteria is inhibited, which helps restore intestinal butyrate supply, improves intestinal barrier function, and promotes the recovery of intestinal motility. By reshaping the balance between butyrate-producing bacteria and pro-inflammatory bacteria, it effectively improves intestinal flora imbalance in IBS.

The invention relates to compositions and methods for treating cancer in a patient comprising subcutaneously administering a PD-1 antagonist, e.g., an anti-PD-1 antibody (e.g. pembrolizumab), or antigen binding fragment thereof, with or without hyaluronidase every six weeks, in specific amounts to the patient. In specific embodiments, the amount of anti-PD-1 antibody, or antigen binding fragment thereof, is about 600 mg to about 1000 mg. In specific embodiments, the administration occurs about every three weeks, and the amount of anti-PD-1 antibody, or antigen binding fragment thereof, is about 300 mg to about 500 mg. In certain embodiments, the PD-1 antagonist is pembrolizumab, or an antigen binding fragment thereof. Also provided are compositions and kits formulated for subcutaneous administration comprising a particular dosage of an anti-PD-1 antibody, or antigen-binding fragment thereof, and uses thereof for treating cancer.

The present invention relates to the technical field of drug delivery and particularly to a freeze-dried formulation of lipid nanoparticles, a preparation method therefor, and use thereof. In the present invention, suitable freeze-dried formulation formulas, including freeze-drying protectant types and concentrations, buffer types and concentrations, and lipid nanoparticle formulas, are screened to obtain a freeze-dried formulation of lipid nanoparticles that comprises 10%-20% w / v sucrose as a single-component freeze-drying protectant, a 1-20 mM Tris or HEPES buffer as a buffer system, and a specific ionizable lipid. The freeze-dried formulation is simple to prepare and still retains excellent physicochemical properties and in vivo transfection efficiency after reconstitution, demonstrating good prospects in the development and application of nucleic acid drugs.

To provide immunogenic compositions capable of providing appropriate protection against Streptococcus pneumoniae serotypes not found in conventional vaccines.SOLUTION: The present invention provides new immunogenic compositions comprising conjugated Streptococcus pneumoniae capsular saccharide antigens (glycoconjugates) and uses thereof. Immunogenic compositions of the present invention typically comprise at least one glycoconjugate from a S. pneumoniae serotype not found in PREVNAR, SYNFLORIX and / or PREVNAR 13. The invention also relates to vaccination of human subjects, in particular infants and elderly, against pneumoccocal infections using the novel immunogenic compositions.SELECTED DRAWING: Figure 1

The application discloses a lyophilized powder of Evf and a preparation method thereof. The lyophilized powder comprises recombinant human acidic fibroblast growth factor, excipient, protein protective agent, pH buffer and lyophilized preparation maintenance agent. The lyophilized powder prepared by the method has high stability and is not easy to be broken into powder in the shaking process, so that electrostatic is avoided due to the friction between the broken powder and the bottle wall in the storage and transportation process, and the product quality is improved.

The invention relates to mRNA comprising lipid nanoparticles and their medical uses. The lipid nanoparticles of the present invention comprise a cationic lipid according to formula (I), (II) or (III) and / or a PEG lipid according to formula (IV), as well as an mRNA compound comprising an mRNA sequence encoding an antigenic peptide or protein. The invention further relates to the use of said lipid nanoparticles as vaccines or medicaments, in particular with respect to influenza or rabies vaccination.

The application belongs to the technical field of biological medicine, and particularly relates to a freeze-dried preparation based on synergistic effect of trehalose and arginine for optimizing the performance of omalizumab reconstitution and a preparation method thereof. The preparation method comprises the following steps: preparing a histidine-hydrochloric acid buffer, dissolving omalizumab, trehalose, arginine and polysorbate 20 in the histidine-hydrochloric acid buffer to prepare a solution preparation; and freeze-drying the solution preparation to obtain the freeze-dried preparation; wherein the molar concentration ratio of trehalose to arginine in the solution preparation is 10-90:15-55. The freeze-dried preparation obtained by using the preparation method has a fast reconstitution speed and a fast bubble disappearance speed during reconstitution, can save time, meets the clinical emergency drug demand, and is more convenient to use.

An antihistamine compound having the structure of formula (I), a pharmaceutically acceptable salt thereof, a method for preparing the same, and use of the antihistamine compound having the structure of formula (I) and a pharmaceutically acceptable salt thereof in the treatment of diseases such as seasonal / perennial allergic rhinitis, allergic conjunctivitis, and urticaria. JPEG2025519827000061.jpg85170

The asthma-relieving pharmaceutical composition based on baicalin-glycyrrhiza polysaccharide self-assembled nanoparticles comprises baicalin-glycyrrhiza polysaccharide self-assembled nanoparticles and at least one auxiliary material suitable for oral administration, wherein the mass ratio of baicalin and glycyrrhiza polysaccharide in the baicalin-glycyrrhiza polysaccharide self-assembled nanoparticles is 1:3-5.

The present invention provides, among other things, stable formulations comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.0 - 7.6, wherein less than approximately 5% of the anti-OSMR antibody exists as high molecular weight (HMW) species in the formulation.

This invention discloses a water-soluble carboxymethyl chitosan-dihydroporphyrin E6 antibacterial repair and regeneration agent, its preparation method, and its application. The structural formula of the carboxymethyl chitosan-dihydroporphyrin E6 antibacterial repair and regeneration agent is as follows: The carboxymethyl chitosan-dihydroporphyrin E6 antibacterial repair and regeneration agent prepared by this invention has good water solubility, strong antibacterial properties, and can promote periodontal tissue repair.

Implants containing lipophilic pharmaceutical agents are described. Excipients are used that provide adequate and controllable / tunable release of the lipophilic drug from the matrix of the implant. The implants can be implanted in a patient for release of the pharmaceutical agent. Methods for making and using such implants are also described.

The present invention provides an improved process for preparing microparticles comprising glatiramer acetate having low levels of residual organic solvent, in particular dichloromethane. The microparticles are incorporated into long-acting parenteral pharmaceutical compositions in a depot form, suitable for subcutaneous or intramuscular implantation or injection and useful for the treatment of multiple sclerosis.

This invention discloses a compound preparation for treating vascular dementia and its preparation method. The active pharmaceutical ingredient consists of protopanaxadiol and gallic acid in a 1:1 mass ratio, and the dosage form is liposomes. The preparation method includes extraction, mixing, liposome preparation, and optional freeze-drying steps: protopanaxadiol and gallic acid are extracted and purified from ginseng rhizome and Terminalia chebula fruit, respectively. After mixing, they are combined with phospholipids and cholesterol to prepare a lipid membrane. The membrane is then homogenized by hydration, low-temperature ultrasound, and high-pressure microfluidic jet to obtain a homogeneous liposome suspension, which can be further freeze-dried into a freeze-dried powder. The 1:1 composition of protopanaxadiol and gallic acid targets multiple points on the pathological mechanism of vascular dementia, showing significant therapeutic effects and broad application prospects. This preparation uses a liposome dosage form to improve the bioavailability of the active ingredient, the preparation process parameters are controllable, the active ingredient has high purity, the liposomes have uniform particle size, high encapsulation efficiency, and good stability.

The application discloses an exosome freeze-drying composition and a preparation method thereof, relates to the field of pharmaceutical preparations, and comprises the following components in parts by mass: 1E9 particles exosome, 1-2 parts of PEG2000 modified beta-sitosterol, 2-4 parts of cholesterol, 20-30 parts of HSA, 30-40 parts of trehalose and 0.5-1.5 parts of poloxamer 188. The preparation method comprises the following steps: step one, preparation of a lipid film; step two, hydration of the liposome; step three, fusion with the exosome; step four, preparation of a pre-freeze-drying suspension; and step five, freeze-drying and sub-packaging. The formula and the preparation method can effectively protect the structural integrity of the exosome in the freeze-drying process and improve the stability of the exosome.

A pharmaceutical composition comprising: an active pharmaceutical ingredient (API); 1-45 wt% non-gelatin matrix former comprising hydroxypropyl methylcellulose (hypromellose, HPMC), methyl cellulose,

The application relates to an influenza vaccine preparation and a preparation method thereof and relates to the technical field of influenza vaccine preparation. The influenza vaccine preparation contains, in the final reconstituted volume of 1000 mL, 50-180 mg of inactivated influenza vaccine of each valence, 1-8 g of wolfberry polysaccharide, 1-5 g of low-molecular-weight sodium hyaluronate, 8-23 g of a mixture of trehalose and mannitol, 6-10 g of an osmotic pressure regulator, 1-2 g of a buffer, and the balance of water.

Provided are a pharmaceutical composition comprising an anti-Nectin-4 antibody-drug conjugate and its use. The provided pharmaceutical composition has good stability.

The present invention relates to a stable pharmaceutical composition of a pharmacologically active fusion protein,, comprising a suitable buffering agent, stabilizer and surfactant wherein the composition essentially consisting of single sugar and essentially free of mannitol wherein the formulation maintains the purity of the fusion protein at least more than 77%. The invention discloses stable lyophilized composition of Thrombopoietin Receptor Agonist (TPO-RA) fusion protein that maintains high purity of the monomer and low level of product-related impurities, at elevated temperatures or during long-term storage, the formulation comprising a suitable buffering agent, stabilizer and surfactant wherein the composition essentially consisting of single sugar and essentially free of mannitol. The use of specific buffer systems (arginine acetate) and excipients help to ensure the stability of the peptibody during the freeze- drying (lyophilization) process and subsequent storage, thereby improving the product's shelf life and stability.

The invention belongs to the technical field of biological medicine, and particularly relates to a clostridium baumannii preparation and application thereof in pet disease treatment. The clostridium baumannii is prepared into a freeze-dried microbial inoculum, the freeze-dried microbial inoculum is matched with prebiotics, and the prebiotics can provide nutritional support and enhance the biological activity of the clostridium baumannii; meanwhile, the in-vivo microecological balance can be adjusted, in addition, the protein protective agent, the saccharide protective agent and other components added into the freeze-dried microbial agent can effectively maintain the activity of the clostridium baumannii, the shelf life of the preparation is prolonged, and the stability and reliability of the clinical application effect are guaranteed. According to the invention, a dosage form with an excellent effect is obtained by screening the components with different proportions, and the dosage form shows a more excellent effect in the aspect of treating the dog and cat osteoarthritis. The clostridium baumannii preparation can effectively inhibit inflammatory response caused by arthritis and relieve inflammatory injury, and the raw materials adopted by the clostridium baumannii preparation are natural, high in safety, free of obvious toxic and side effects and suitable for different individual pets.

The present disclosure relates generally to compositions, dosage forms, and methods for preventing and treating cancers and infections. An example method entails administering to the patient an effective amount of a composition comprising 1 × 107 to 500 × 107 intact, stabilized and substantially non-viable E. coli cells which have been treated in such a way as to result in about 70% to 99% reduction of lipopolysaccharide (LPS)-associated endotoxin activity when measured by the Limulus Amebocyte Lysate (LAL) assay as compared to untreated, wild-type E. coli cells, and wherein the composition contains 124 to 62000 endotoxin units (EU) of LPS.