Table 1.
Marketed solid dispersion formulations.
| S. no. | Drug | Class | Method | Carrier | Manufacturer | Trade name | Dosage form | Year approval | USFDA orange book application number | Status |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Nabilone | Anti cancer | Solvent evaporation | PVP | Valeant | Cesamet® | Capsule | FDA (1985) | N018677 | Prescription |
| 2 | Itraconazole | Anti fungal | Fluid bed bead layering | HPMC | Janssen Pharmaceuticals Inc. | Sporanox® | Capsule | FDA (1992) | N020083 | Prescription |
| 3 | Tacrolimus | Organ transplantation | Kneading, drying | HPMC | Astellas | Prograf | Capsules | FDA/MHRA (1994) | N050708 | Prescription |
| 4 | Verapamil | Anti hypertensive | Hot melt extrusion | HPMC/HPC | Abbot | Isoptin SR | Tablets | FDA (1987) | N018593 | Withdrawn |
| 5 | Troglitazone | Anti diabetic | Hot melt extrusion | HPMC | Pfizer | Rezulin® | Tablets | FDA (1997) | N020720 | Withdrawn |
| 6 | Rosuvastatin | Anti hyperlipidemic | Spray drying | HPMC | Astra Zeneca | Crestor® | Tablets | 2002 (FDA) 2004 (EMA) |
N021366 | Prescription |
| 7 | Duloxetine | Depression | NA | HPMCAS | Eli Lilly | Cymbalta | Capsule | FDA (2004) | N021427 | Prescription |
| 8 | Lopinavir/Ritonavir | AIDS | Melt extrusion | PVP | Abb Vie | Kaletra | Tablets | EMA (2001) FDA (2005) |
N021906 | Prescription |
| 9 | Vildagliptin/Metformin HCl | Anti diabetic | Melt extrusion | HPC | Novartis | Eucreas/Galvusmet | Tablets | EMA (2007) | NA | NA |
| 10 | Fenofibrate | Hyperlipidemia | Spray melt | PEG6000 Poloxamer 188 |
Santorus Veloxis |
Fenoglide | Tablets | FDA (2010) | N022118 | Prescription |
| 11 | Etravirine | AIDS | HME | HPMC | J & J | Intelence | Tablets | FDA/EMA (2008) | N022187 | Prescription |
| 12 | Tolvaptan | Hyponatremia | Granulation | NA | Otsuka | Samsca | Tablets | FDA/EMA (2009) | N022275 | Prescription |
| 13 | Itraconazole | Onychomycosis | Hot melt extrusion | HPMC | Merz | Onmel | Tablets | FDA (2010) | N022484 | Prescription |
| 14 | Everolimus | Organ transplantation | Co-precipitation | HPMC | Novartis | Certican/Zortress | Tablets | FDA/EMA (2010) | N021560 | Prescription |
| 15 | Ritonavir | AIDS | HME | PVP | Abbvie | Norvir | Tablets | EMA(2009) FDA (2010) |
N022417 | Prescription |
| 16 | Vemurafenib | Cancer | Co-precipitation | HPMCAS | Roche | Zelboraf | Tablets | FDA (2011) EMA (2012) |
N202429 | Prescription |
| 17 | Telaprevir | Hepatitis | Spray drying | HPMCAS | Vertex | Incivek | Tablets | EMA/FDA (2011) | N201917 | Withdrawn |
| 18 | Itraconazole | Fungal infection | Spray drying | HPMCP | Mayne | Lozanoc | Capsules | NA | NA | NA |
| 19 | Ivacaftor | Cystic fibrosis | Spray drying | HPMC-AS | Vertex | Kalydeco | Tablet | EMA/FDA (2012) | N203188 | Prescription |
| 20 | Tacrolimus | Organ transplantation | Wet granulation | HPMC | Astellas | Advagraf/Astagraf XL | Capsules | FDA 2012 | N204096 | Prescription |
| 21 | Posaconazole | Fungal infection | HME | HPMCAS | Merck | Noxafil | Tablet | FDA (2013) EMA (2014) |
N205053 | Prescription |
| 22 | Etravirine | AIDS | Spray drying | HPMC | Tibotec | Intelence | Tablet | FDA 2008 | N022187 | Prescription |
| 23 | Regorafenib | Cancer | NA | Povidone K25 | Bayer | Stivarga | Tablet | FDA 2012 | N203085 | Prescription |
| 24 | Silibinin | NA | Spray drying | Lecithin | Tianjin Tasly | Shuilinjia | Capsule | NA | NA | NA |
| 25 | Everolimus | Immunosuppressant | Spray drying | HPMC | Novartis | Votubia | Tablet | EMA/FDA (2010) | NA | NA |
| 26 | Nilvadipine | Hypertension | Spray drying | HPMC | Fujisawa | Nivadil | Tablet | NA | NA | NA |
| 27 | Griseofulvin | Fungal infection | Melt extrusion | PEG6000 | Pedinol | Gris-PEG | Tablet | 1982 | N050475 | Prescription |
| 28 | Florfenicol | NA | Enteric cellulose | Hebei Huaqiang | Flofenicol | Powder | NA | NA | NA | |
| 29 | Ivacaftor; Lumacaftor | Cystic fibrosis | Spray drying | HPMCAS/SLS | Vertex Pharmaceuticals Inc. | Orkambi | Tablet | 2015 | N206038 | Prescription |