GLP Tablet

GLP Tablet (Glucagon Like Peptide-1) is an intestinal insulinotropic hormone secreted by intestinal L cells. Its core function includes stimulating pancreatic beta cells to secrete insulin (glucose dependent) while inhibiting pancreatic alpha cells to secrete glucagon, forming a "bidirectional regulation" mechanism and effectively reducing postprandial blood glucose fluctuations. It can inhibit gastrointestinal peristalsis, prolong the time food stays in the stomach, and reduce the rapid rise of postprandial blood sugar.

Acting on the appetite regulation center of the hypothalamus in the central nervous system, enhancing satiety and reducing food intake. It can promote fat breakdown, inhibit fat synthesis, improve blood lipid profile (reduce triglycerides, increase high-density lipoprotein cholesterol), and has potential cardiovascular protective effects. Natural GLP-1 is easily degraded by dipeptidyl peptidase-4 (DPP-4) in the body, with a half-life of only 1-2 minutes. Tablets need to be swallowed whole and cannot be broken, chewed, or crushed. They should be taken with a glass of water.

GLP Tablet

GLP-1 Capsule

GLP-1 Injection

GLP-1 COA

Certificate of Analysis
Compound name	GLP-1
Grade	Pharmaceutical grade
CAS No.	87805-34-3
Quantity	Customized
Packaging standard	Customized
Manufacturer	Shaanxi BLOOM TECH Co., Ltd
Lot No.	202601090032
MFG	Jan 9th 2026
EXP	Jan 8th 2029
Item	Enterprise standard	Analysis result
Appearance	White or almost white powder	Conformed
Water content	≤5.0%	0.52%
Loss on drying	≤1.0%	0.35%
Heavy Metals	Pb≤0.5ppm	N.D.
	As≤0.5ppm	N.D.
	Hg≤0.5ppm	N.D.
	Cd≤0.5ppm	N.D.
Purity (HPLC)	≥99.0%	99.90%
Single impurity	<0.8%	0.47%
Total microbial count	≤750cfu/g	92
E. Coli	≤2MPN/g	N.D.
Salmonella	N.D.	N.D.
Ethanol (by GC)	≤5000ppm	400ppm
Storage	Store in a sealed, dark, and dry place below -20°C

GLP Tablet (glucagon like peptide-1) is a major breakthrough in the treatment of diabetes and obesity. It can achieve comprehensive improvement in blood glucose regulation, weight control and metabolism by simulating the physiological effects of natural GLP-1

The manufacturing process of GLP-1 is mainly divided into two categories: biological synthesis and chemical synthesis. In actual production, a combination of the two is often used to optimize cost and efficiency.

Biosynthetic method

 

The biosynthetic method focuses on microbial fermentation and expresses GLP-1 precursor peptides through genetically engineered yeast or Escherichia coli. For example, in Novo Nordisk's production of semaglutide, yeast cells are designed to secrete GLP-1 main chains, and after fermentation, the fermentation broth containing the target peptide is harvested.

The advantage of this method lies in the easy availability of raw materials and low production costs, but the purity of the product is low and requires multiple subsequent purification steps. The fermentation broth needs to be sequentially subjected to techniques such as low-pressure ion exchange chromatography, medium high pressure reverse phase chromatography, and tangential flow filtration to gradually remove impurities and concentrate the target peptide.

Chemical synthesis method

The chemical synthesis method is mainly based on solid-phase synthesis, which gradually couples amino acids to form polypeptide chains through resin carriers.Company's Tilpotide adopts a solid-liquid mixing method: first, four short peptide fragments are segmented and synthesized by liquid-phase synthesis, and then the fragments are connected into complete peptides by solid-phase synthesis. The chemical synthesis method can accurately control the peptide sequence and modification sites, but the yield is low when synthesizing long chains, and the coupling efficiency and purification steps need to be optimized.

Semi fermentation method

The semi fermentation method combines the advantages of biological and chemical synthesis, first producing GLP tablet main chain through fermentation, and then introducing fatty acid side chains or non natural amino acids through chemical modification.

For example, the C18 fatty acid side chain of semaglutide is chemically coupled to the main chain, significantly prolonging its half-life. This method combines the large-scale production capacity of fermentation method with the structural accuracy of chemical synthesis method, becoming the mainstream manufacturing path for long-acting GLP-1 drugs.

The manufacturing of GLP tablets relies on high-quality raw materials, and their selection directly affects drug activity and stability

Amino acids and protecting groups

Peptide synthesis requires the use of high-purity (≥ 99%) L-type amino acids, among which the introduction of non natural amino acids (such as alpha aminoisobutyric acid) can enhance the drug's resistance to enzymatic hydrolysis. In addition, protective groups need to be used during the synthesis process to protect the amino acid side chains and prevent side reactions from occurring. The removal of protective groups requires strict control of conditions to ensure the integrity of the polypeptide chain.

Fatty acid side chains

Fatty acid side chains are the key to prolonging the half-life of GLP-1 drugs. The C18 diacid side chain of semaglutide is covalently linked to the main chain, increasing molecular hydrophobicity and promoting its binding with plasma albumin, thereby reducing renal filtration. The synthesis of fatty acid side chains requires high-purity raw materials (≥ 98%), and chain length and saturation must be controlled to ensure drug metabolic stability.

Absorption enhancer

Oral GLP-1 drugs need to overcome the low pH and enzymatic environment of the gastrointestinal tract, and the application of absorption enhancers (such as SNAC) is crucial. SNAC (Sodium N - (8- [2-hydroxybenzoyl] - amino) octanoate) locally increases the pH value in the stomach, reduces the degradation of peptides by gastric proteases, and promotes drug cross cellular transport. Its purity needs to be ≥ 99%, and the particle size distribution needs to be controlled to optimize absorption efficiency.

The quality control of GLP-1 oral tablets runs through the entire production process, including raw material inspection, intermediate purification, and finished product stability testing.

Purity control

Peptide purity should be ≥ 99.5% to reduce immunogenicity and metabolic side effects. The purification process usually uses a combination of reverse phase chromatography (RPC) and ion exchange chromatography (IEC), combined with ultrafiltration and liquid exchange technology to remove impurities. For example, the purification of semaglutide requires a three-step chromatography process: the first step captures the target peptide, the second step removes missing sequence impurities, and the third step further refines it. The selection of ultrafiltration membrane packaging should consider retention rate (≥ 99%), organic solvent tolerance (such as acetonitrile ≤ 70%), and pressure resistance (positive TMP ≤ 5.5 bar).

Structural confirmation

The molecular structure of drugs needs to be confirmed by mass spectrometry (MS), nuclear magnetic resonance (NMR), and circular dichroism spectroscopy (CD) to ensure that the amino acid sequence, side chain modification, and spatial conformation are consistent with theoretical design. For example, the GLP-1/GIP dual receptor agonist structure of tilpotide requires verification of the correct folding and interaction of the two active regions.

stability test

The finished product needs to undergo long-term stability testing (such as 24 months of storage under 25 ℃/60% RH conditions) to monitor changes in drug content, related substances, and dissolution rate. Oral tablets also need to be evaluated for moisture absorption, fragility, and disintegration time to ensure their quality stability during storage and transportation.

 

The manufacturing technology of GLP-1 oral tablets is developing towards greater efficiency and precision, while its indications continue to expand.

Small molecule GLP-1 receptor agonist

Currently, most oral GLP-1 drugs are peptides that require absorption enhancers to enhance their bioavailability. The development of small molecule agonists can overcome this limitation by directly absorbing them orally, simplifying production processes, and reducing costs. For example,Orforglipron has entered phase III clinical trials and has been shown to significantly reduce blood sugar and body weight when taken orally once a day.

Multi targeted drugs

Dual/triple agonists of GLP-1 and receptors such as GIP and GCGR can synergistically regulate metabolism and enhance therapeutic efficacy. As the world's first GLP-1/GIP dual agonist, Tilpotide has a better weight loss effect than single target drugs. The manufacturing of future multi-target drugs requires optimization of the synthesis and purification processes of polypeptide chains to ensure correct folding and proportional control of each active region.

Indications expansion

GLP-1 shows potential in cardiovascular risk, diabetes nephropathy, non-alcoholic steatohepatitis (NASH), Alzheimer's disease and other fields. For example, semaglutide can reduce the risk of cardiovascular events by 26%, and its manufacturing process needs to meet higher purity and stability requirements to support long-term treatment needs.

Continuous production technology

The traditional batch production mode has the problems of low efficiency and high cost. Continuous production technology (such as continuous flow chromatography and continuous drying) can achieve seamless connection from raw materials to finished products, significantly improving production efficiency. For example, spray drying technology maintains polypeptide activity through instant drying, with high productivity and low cost, and has become the mainstream of polypeptide drying.

FAQ

Is GLP-1 similar to Ozempic?

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