Table 2.
Formulations and storage conditions for GLP-1 RA products
| Product | Dosage form | Strength | Excipients | Shelf-life (in use stability) |
Ref |
|---|---|---|---|---|---|
| Exenatide BID Byetta® |
Solution in multi-dose prefilled pens | 300 μg in 1.2 ml 600 μg in 2.4 ml |
Mannitol (43 mg/ml), metacresol (2.2 mg/ml), glacial acetic acid and sodium acetate trihydrate. (pH 4.5) | 3 years at 2-8°C (30 days <25°C) |
[19, 29, 30] |
| Lixisenatide Adlyxin® |
Solution in multi-dose prefilled pens | 150 μg in 3 ml 300 μg in 3 ml |
Glycerol 85% (18 mg/ml), methionine (3.0 mg/ml), metacresol (2.7 mg/ml), sodium acetate trihydrate (3.5/ml mg), hydrochloric acid and sodium hydroxide (pH 4.5) | 2 years at 2-8°C (14 days < 30°C) |
[25, 31, 32] |
| Liraglutide Victoza® |
Solution in multi-dose prefilled pens | 18 mg in 3 ml | Propylene glycol (14.0 mg/ml), phenol (5.50 mg/ml), disodium phosphate dihydrate (1.42 mg/ml) (pH 8.15) | 30 months at 2-8°C (30 days at 2-8°C or 15-30°C) |
[20, 33] |
| Semaglutide Ozempic® |
Solution in multi-dose prefilled pens | 2 mg in 1.5 ml | Propylene glycol (14.0 mg/ml), phenol (5.50 mg/ml), disodium phosphate dihydrate (1.42 mg/ml), hydrochloric acid and sodium hydroxide (pH 7.4) | 3 years at 2-8°C (56 days at 2-8°C or 15-30°C) |
[34, 35] |
| Albiglutide Tanzeum® |
Lyophilized powder and solvent in single-dose prefilled dual-chamber pens | 30 mg or 50 mg in 0.5 ml after reconstitution | Mannitol (27.9 mg/ml), polysorbate 80 (0.01% w/w), sodium phosphate (1.64 mg/ml), trehalose dihydrate (44.3 mg/ml) | 3 years at 2-8°C (4 weeks < 30°C) |
[23, 36] |
| Dulaglutide Trulicity® |
Solution in single-dose prefilled syringes or pens | 0.75 mg in 0.5 ml 1.5 mg in 0.5 ml |
Mannitol (46.4 mg/ml), polysorbate 80 (0.20 mg/ml), citric acid anhydrous (0.14 mg/ml), trisodium citrate dihydrate (2.74 mg/ml) | 2 years at 2-8°C (14 days <30°C) |
[24, 37] |
| Exenatide QW Bydureon® |
Powder and diluent supplied with trays. Powder and diluent in single-dose dual-chamber pens |
2 mg in 0.65 ml after resuspension | 50:50 PLGA (57.2 mg/ml), sucrose (1.2 mg/ml), sodium chloride (6.3 mg/ml), carboxymethylcellulose sodium (29.2 mg/ml), polysorbate 20 (0.01 mg/ml), sodium phosphate monobasic monohydrate (0.9 mg/ml), sodium phosphate dibasic heptahydrate (0.78 mg/ml), sodium hydroxide | 3 years at 2-8 °C (4 weeks < 25°C) |
[21, 38] |
| Exenatide QW Bydureon® BCISE |
Suspension in single dose injector | 2 mg in 0.85 ml | 50:50 PLGA (43.7 mg/ml), sucrose (0.94 mg/ml); medium chain triglycerides (875.8 mg/ml) | 3 years at 2-8°C (4 weeks <25°C) |
[39] |
| Liraglutide and insulin degludec | Solution in multi-dose prefilled pens | 300 units insulin degludec and 10.8 mg | Glycerol 19.7 mg/ml, phenol 5.70 mg/ml, zinc 55 μg/ml, hydrochloric acid and sodium hydroxide (pH 8.15) | 2 years at 2-8°C (21 days at 2-8°C or 15-30°C) |
[27, 40] |
| Xultophy® 100/3.6 | liraglutide in 3 ml | ||||
| Lixisenatide and insulin glargine SOLIQUA® 100/33 |
Solution in multi-dose prefilled pens | 300 units insulin glargine and 100 μg lixisenatide in 3 ml | Glycerol 20 mg/ml, methionine 3 mg/ml, metacresol 2.7 mg/ml, zinc 30 μg/ml, hydrochloric acid and sodium hydroxide | 2 years at 2-8°C (28 days <25°C) |
[28, 41] |