Tirzepatide

Overview

Tirzepatide is a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. This unique dual mechanism provides enhanced glycemic control and weight management benefits compared to single-target therapies. Our pharmaceutical-grade compounded formulation is manufactured in an FDA-registered 503B facility under strict cGMP conditions, ensuring consistent quality and potency for healthcare professionals.

Mechanism of Action

Tirzepatide functions as a dual agonist, binding to both GIP and GLP-1 receptors. The GLP-1 component stimulates insulin secretion, suppresses glucagon release, and slows gastric emptying. The GIP component enhances insulin secretion and may improve lipid metabolism. This dual action results in superior glycemic control and weight reduction compared to GLP-1-only agonists. The peptide structure includes modifications that extend its half-life, allowing for once-weekly administration.

Pharmacology

• Dual receptor agonism: Activates both GIP and GLP-1 receptors with high affinity
• Extended half-life: Approximately 5 days, enabling once-weekly dosing
• Glucose-dependent insulin secretion: Reduces hypoglycemia risk
• Delayed gastric emptying: Contributes to satiety and reduced caloric intake
• Central appetite regulation: Acts on hypothalamic centers to reduce food intake
• Improved beta-cell function: May preserve pancreatic function over time

Stability & Storage

• Storage temperature: 2-8°C (36-46°F) - refrigeration required
• Protect from light: Store in original container until use
• Stability data: Comprehensive stability testing performed per USP guidelines
• Beyond-use date: Provided with each batch based on stability studies
• Handling: Allow to reach room temperature before administration
• Do not freeze: Freezing may denature the peptide structure

Testing & Release Criteria

• Sterility testing: USP <71> - Sterility Tests performed on every batch
• Bacterial endotoxin testing: USP <85> - LAL test to ensure pyrogenicity limits
• Potency assay: HPLC analysis confirming 95-105% of labeled amount
• Identity testing: Mass spectrometry confirmation of molecular structure
• pH testing: Verified within acceptable range for injectable formulations
• Particulate matter: USP <788> - Sub-visible particulate testing
• Container closure integrity: Ensures sterility maintenance throughout shelf life
• Stability indicating methods: Validated analytical procedures for degradation products