Abstract
Oral administration of proteins and peptides is extremely difficult due to the nature of the digestive system, which is designed to break down polypeptides into amino acids before absorption. The low bioavailability of drugs is still an active area of research, and researchers have investigated several places in the gastrointestinal tract, but an important breakthrough that would be widely applicable to various proteins and peptides have not been achieved. Semaglutide is a recombinant long acting GLP-1 receptor agonist. Semaglutide is structurally represented as:
The present study aimed to develop and characterize a dosage form provides stabilized pharmaceutical compositions to enhance the pharmacokinetic profile of Semaglutide by using one or more permeation enhancers, along with pharmaceutically acceptable excipients and process for the preparation thereof, thereby reducing fluctuations in plasma concentration and improving bioavailability.
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Example 1
| Sno. | Excipients Mg/Uni | Mg/Uni | |||||
|---|---|---|---|---|---|---|---|
| Intragranular | 1 | 3mg | 7mg | 14mg | 1.5mg | 4mg | 9mg |
| 1 | Semaglutide | 3.00 | 7 | 14 | 1.5 | 4.00 | 9.00 |
| 2 | Microcrystalline Cellulose | 144 | 140 | 133 | 146.0 | 143.00 | 138.0 |
| 3 | Povidone | 12 | 12 | 12 | 12 | 12 | 12 |
| 4 | Sodium Salcaprozate SNAC | 400 | 400 | 400 | 400.00 | 400.00 | 400.00 |
| 5 | Magnesium Stearate | 10 | 10 | 10 | 10 | 10 | 10 |
| Intragranular | 2 | ||||||
| 6 | Sodium Salcaprozate SNAC | 400 | 400 | 400 | 400 | 400 | 400 |
| 7 | Povidone | 11 | 11 | 11 | 11 | 11 | 11 |
| 8 | Microcrystalline Cellulose | 100 | 100 | 100 | 100 | 100 | 100 |
| 9 | Magnesium Stearate | 10 | 10 | 10 | 10 | 10 | 10 |
| Extra-granular | |||||||
| 11 | Magnesium Stearate | 10 | 10 | 10 | 10 | 10 | 10 |
| 12 | TOTAL WEIGHT | 1100 | 1100 | 1100 | 1100 | 1100 | 1100 |
INTRODUCTION
The current research pertains to a pharmaceutical formulation intended for oral use, which includes Semaglutide or its pharmaceutically acceptable salts or derivatives, one or more permeation enhancers, as well as pharmaceutically acceptable excipients and the method for its preparation. A pharmaceutical composition comprising Semaglutide and one or more permeation enhancers selected from Labrasol, Capryol, 5-CNAC, 5-CNAC Disodium, Salcaprozate Sodium (SNAC), Vitamin E TPGS, Gelucire, Soyabean lecithin, Lysine, Phenyl alanine, Tryptophan, Sodium caprylate, Sodium caprate, Capsaicin analogue, Sodium laurate, Sodium chenodeoxycholate, Propyl gallate, Sodium octanoate, Sodium nonanoate, Sodium decanoate, Sodium undecanoate, Sodium dodecanoate, Sodium tridecanoate, Dodecyl maltoside, Tridecyl maltoside, Tetradecyl maltoside, Sucrose mono dodecanoate, Sucrose mono-tridecanoate, Sucrose mono-tetradecanoate, Sodium dodecyl sulfate, Sodium hexanoate, Sodium heptanoate, Sodium tetradecanoate, and combinations thereof.
The pharmaceutical composition comprises semaglutide and pharmaceutically acceptable excipients selected from the group consisting of permeation enhancer, binders, solubilzer, diluents, disintegrants, lubricants, glidants, antioxidants, pH adjusting agents, flavouring agent, colorants and sweetening agent etc.
The pharmaceutical formulation provided herein comprises permeation enhancers, which are included in formulations to improve the absorption of a pharmacologically active drug.
Download the full article as PDF here: METHOD FOR THE PREPARATION OF SEMAGLUTIDE TABLET
Srinivas reddy, Tummuru and HUSSAIN KHAN, BAJI, “METHOD FOR THE PREPARATION OF SEMAGLUTIDE TABLET”, Technical Disclosure Commons, (September 16, 2025)
https://www.tdcommons.org/dpubs_series/8596
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