From the Research
Semaglutide tablets are typically made from the active pharmaceutical ingredient (API) in powder form, not from a lyophilized form. The manufacturing process for oral semaglutide (brand name Rybelsus) involves combining the semaglutide powder with an absorption enhancer called sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC), which protects the peptide from degradation in the stomach and facilitates its absorption in the gastrointestinal tract, as described in the study by 1. This is necessary because semaglutide is a peptide that would normally be broken down by digestive enzymes before it could be absorbed. The powder form of semaglutide is preferred for tablet manufacturing as it allows for better mixing with excipients and provides greater stability during the tablet compression process. Some key points to consider include:
- The importance of the absorption enhancer in facilitating the absorption of semaglutide in the gastrointestinal tract, as noted in the study by 1.
- The stability of the powder form of semaglutide during the tablet compression process, which is crucial for ensuring the quality of the final product.
- The differences between the oral and injectable formulations of semaglutide, with the latter often utilizing lyophilization to maintain stability, as mentioned in the study by 2. Lyophilization (freeze-drying) is more commonly used for injectable formulations of semaglutide (like Ozempic or Wegovy) to maintain stability in liquid form after reconstitution, but is not the starting material for the oral tablet formulation. Further studies, such as the one by 3, have investigated the relationship between oral semaglutide tablet erosion and pharmacokinetics, providing additional insights into the behavior of the powder form of semaglutide in the body. Overall, the use of powder form semaglutide in tablet manufacturing is a critical aspect of ensuring the efficacy and safety of oral semaglutide products, as supported by the evidence from studies such as 1, 4, and 3.