ChinaFinishedDosageFormSuppliers DESCRIPTION Dulaglutide is a

Comments · 56 Views

ChinaFinishedDosageFormSuppliers DESCRIPTION Dulaglutide is a human glucagon-like peptide-1 (GLP-1) receptor agonist.

ChinaFinishedDosageFormSuppliers DESCRIPTION Dulaglutide is a human glucagon-like peptide-1 (GLP-1) receptor agonist. The molecule is a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker and is produced using mammalian cell (Chinese hamster ovary) culture. The GLP-1 analog portion of dulaglutide is 90% homologous to native human GLP-1 (7-37). Structural modifications were introduced in the GLP-1 part of the molecule responsible for interaction with the enzyme dipeptidyl-peptidase-IV (DPP-4). Additional modifications were made in an area with a potential T-cell epitope and in the areas of the IgG4 Fc part of the molecule responsible for binding the high-affinity Fc receptors and half-antibody formation. The overall molecular weight of dulaglutide is approximately 63 kilodaltons. DULAGLUTIDE (dulaglutide) injection is a clear, colorless, sterile, preservative-free solution for subcutaneous use. Each single-dose pen contains a 0.5 mL solution of 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg of dulaglutide and the following excipients: citric acid anhydrous (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg for 0.75 mg and 1.5 mg; 0.125 mg for 3 mg and 4.5 mg), and trisodium citrate dihydrate (1.37 mg), in water for injection. Mechanism of Action DULAGLUTIDE contains dulaglutide, which is a human GLP-1 receptor agonist with 90% amino acid sequence homology to endogenous human GLP-1 (7-37). Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying. Pharmacodynamics DULAGLUTIDE lowers fasting glucose and reduces postprandial glucose (PPG) concentrations in patients with type 2 diabetes mellitus. The reduction in fasting and postprandial glucose can be observed after a single dose. Fasting and Postprandial Glucose In a clinical pharmacology study in patients with type 2 diabetes mellitus, treatment with once weekly DULAGLUTIDE resulted in a reduction of fasting and 2-hour PPG concentrations, and postprandial serum glucose incremental AUC, when compared to placebo (-25.6 mg/dL, -59.5 mg/dL, and -197 mg*h/dL, respectively); these effects were sustained after 6 weeks of dosing with the 1.5 mg dose. First- and Second-Phase Insulin Secretion Both first- and second-phase insulin secretion were increased in patients with type 2 diabetes treated with DULAGLUTIDE compared with placebo. Insulin and Glucagon Secretion DULAGLUTIDE stimulates glucose-dependent insulin secretion and reduces glucagon secretion. Treatment with DULAGLUTIDE 0.75 mg and 1.5 mg once weekly increased fasting insulin from baseline at Week 26 by 35.38 and 17.50 pmol/L, respectively, and C-peptide concentration by 0.09 and 0.07 nmol/L, respectively, in a monotherapy trial. In the same trial, fasting glucagon concentration was reduced by 1.71 and 2.05 pmol/L from baseline with DULAGLUTIDE 0.75 mg and 1.5 mg, respectively. Gastric Motility Dulaglutide causes a delay of gastric emptying. The delay in gastric emptying is dose-dependent but is attenuated with adequate dose escalation to higher doses of DULAGLUTIDE. The delay is largest after the first dose and diminishes with subsequent doses. Cardiac Electrophysiology (QTc) The effect of dulaglutide on cardiac repolarization was tested in a thorough QTc study. Dulaglutide did not produce QTc prolongation at doses of 4 and 7 mg. The maximum recommended dose is 4.5 mg once weekly. Name: Dulaglutide DULAGLUTIDE contains dulaglutide, a human GLP-1 receptor agonist. The molecule is a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker and is produced using mammalian cell culture. The GLP-1 analog portion of dulaglutide is 90% homologous to native human GLP-1 (7-37). Structural modifications were introduced in the GLP-1 part of the molecule responsible for interaction with the enzyme dipeptidyl-peptidase-IV (DPP-4). Additional modifications were made in an area with a potential T-cell epitope and in the areas of the IgG4 Fc part of the molecule responsible for binding the high-affinity Fc receptors and half-antibody formation. The overall molecular weight of dulaglutide is approximately 63 kilodaltons. Dosage: Injection Specification 0.75mg: 0.5ml, 1.5mg : 0.5ml, Indications DULAGLUTIDE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. In 2020, the company's RD center and some production lines settled in Hangzhou Pharmaceutical Town, and the level of RD and production of software and hardware has been effectively improved. With the help of academician expert workstations, post-doctoral workstations and other scientific research platforms, Jiuyuan vigorously develops the research and development of macromolecular drugs focusing on insulin and monoclonal antibodies. Based on the product positioning of innovative drugs and generic drugs, and both biological drugs and chemical drugs, the company focuses on the development of new drugs in the fields of tumor, blood, cardiovascular, hepatitis, diabetes, etc. The company has successively won many honorary titles such as National High-tech Enterprise, National Torch Program Key High-tech Enterprise, Provincial Science and Technology Progress Second Prize, Provincial Famous Trademark, Provincial High-tech Research and Development Center, etc. Company Honor National New High-tech Enterprise Key New High-tech Enterprise of National Torch Plan National superior enterprise of intellectual property Provincial New High-tech Research Development Center Zhejiang Provincial Enterprise Technology Center Zhejiang Famous Trademark Zhejiang Jiuyuan Gene Engineering Biopharmaceutical Research Institute FAQ Q: Are you trading company or manufacturer? A: We are professional manufacturer specialized in the research, development, manufacture and marketing of pharmaceuticals based on gene engineering and biochemical technology since 1993. And we trade our products with our clients directly. Q: How many different types of products your company manufactures? A: Now we have 36 products including pipeline products. All the pharmaceutical manufacturing activities are carried as per GMP requirements. The day to day licensing and regulatory activities are controlled by SFDA. Q: When can I get the price? A: Usually we quote within 8 hours after we get your inquiry. Q: What's your MOQ? A: If we have the products in stock, it will be no MOQ. If we need to produce, we can discuss the MOQ according to customer's exact situation. Q: How long is your delivery time? A: The general delivery time is 30-45 days after receiving your order confirmation. if we have the goods in stock, it will only take 1-2 days. Our Services 1. Good knowledge on different market can meet special requirements. 2. Real manufacturer with our own factory located in china. 3. Strong professional technical team ensure to produce the top quality products. 4. Special cost control system ensure to provide the most favorable price. 5. Rich experience on drug.ChinaFinishedDosageFormSuppliers website:http://www.jiuyuangene.net/finished-dosage-form/

Comments