| Autor: |
Annereau M; Clinical Pharmacy Department, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, 94800 Villejuif, France.; EA 401: Matériaux et Santé, Université Paris-Sud, UFR Pharmacie, 92290 Châtenay-Malabry, France., Hinterlang M; Clinical Pharmacy Department, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, 94800 Villejuif, France., Bienayme H; Orphelia Pharma, 85 Boulevard Saint-Michel, 75005 Paris, France., Vassal G; Oncopaediatric Department, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, 94800 Villejuif, France., Pinon A; Clinical Pharmacy Department, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, 94800 Villejuif, France., Schmitt M; Orphelia Pharma, 85 Boulevard Saint-Michel, 75005 Paris, France., Denis L; Clinical Pharmacy Department, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, 94800 Villejuif, France., Lemarchand C; Orphelia Pharma, 85 Boulevard Saint-Michel, 75005 Paris, France., Martin L; Orphelia Pharma, 85 Boulevard Saint-Michel, 75005 Paris, France., Lemare F; Clinical Pharmacy Department, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, 94800 Villejuif, France., Abbou S; Oncopaediatric Department, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, 94800 Villejuif, France., Bastid J; Orphelia Pharma, 85 Boulevard Saint-Michel, 75005 Paris, France., Tortolano L; EA 401: Matériaux et Santé, Université Paris-Sud, UFR Pharmacie, 92290 Châtenay-Malabry, France.; Département de Pharmacie, Hôpital Universitaire Henri Mondor, AP-HP, F-94010 Créteil, France. |
| Abstrakt: |
The development of oral pediatric forms by pharmaceutical companies is still insufficient. In fact, many drugs used in paediatric oncology, such as temozolomide, are not labeled and adapted for paediatric use. Temozolomide (TMZ) is an alkylating agent used as the standard of care for many adult and pediatric brain tumours, such as neuroblastoma, glioblastoma and medulloblastoma. The present study was carried out to propose a suitable and palatable formulation of the oral liquid preparation of TMZ. The suspension is composed of TMZ suspended in SyrSpend SF pH 4, as well as TMZ crystallization stabilizing agents and sweetening agents. To reach this formulation, several taste-masking agents were evaluated. Here, we describe the method of preparation of the formation as well as the monocentric population treated with the formulation over a 5-year period. A 20 mg/mL TMZ suspension was developed. TMZ suspension is stable for 6 weeks, stored between 2 and 8 degrees, protected from light, and compatible with nasogastric tubes. Thirty-eight patients participated in the palatability study and choose cola flavour, and 104 patients were treated in Gustave Roussy with the developed suspension; no unexpected event was reported. To conclude, we propose here a new TMZ liquid formulation which is stable for at least 6 weeks and well-tolerated with extensive feedback. |
