Stability of Reconstituted and Diluted Mitomycin C Solutions in Polypropylene Syringes and Glass VialsAbstract


Autoria(s): Briot, Thomas; Truffaut, Christine; Le Quay, Luc; Lebreton, Anne; Lagarce, Frédéric
Contribuinte(s)

Micro et nanomédecines biomimétiques (MINT) ; Université d'Angers (UA) - Institut National de la Santé et de la Recherche Médicale (INSERM)

Data(s)

2016

Resumo

International audience

<p>Purpose: Mitomycin C (MMC) is widely used in treatment of non-muscle invasive bladder cancer at a 1 mg/mL concentration, by intravesical instillation. MMC is also used as an ophthalmic procedure in glaucoma care mostly with 0.2 mg/mL concentration. To accelerate syringes provision, it could be interesting to demonstrate the stability of the drug, in order to be able to prepare the chemotherapeutic drug several hours before the chemotherapy administration.</p><p>Methods: A stability indicating HPLC-UV method was developed and validated according to the ICH guidelines. Concentrations of the MMC stored at 25 °C and 60 % of relative humidity and protected from light in polypropylene syringes (1 mg/mL and 0.2 mg/mL) or glass vials (1 mg/mL) were evaluated for 96 h and compared to the initial observed concentrations.</p><p>Results: MMC stability was demonstrated in syringes and glass vials at 1 mg/mL only for 8 h in water for injections and for 10 h at 0.2 mg/mL in 0.9 % sodium chloride solutions, because relative concentrations (95 % confidence interval of the mean of 3 samples) were systematically over 90 % of the initial concentrations. After 96 h the relative concentrations were found below 80 % as compared to initial concentrations, thus indicating instability of these solutions. Degradation products were observed and remained below 3 %.</p><p>Conclusion: This study confirms that MMC solutions for ophthalmic application at 0.2 mg/mL or vesical instillation at 1 mg/mL have to be formulated extemporaneously to maintain the desired concentration.</p>

Identificador

hal-01392484

https://hal.archives-ouvertes.fr/hal-01392484

DOI : 10.1515/pthp-2016-0012

OKINA : ua15095

Idioma(s)

en

Publicador

HAL CCSD

Relação

info:eu-repo/semantics/altIdentifier/doi/10.1515/pthp-2016-0012

Fonte

ISSN: 2365-2411

Pharmaceutical Technology in Hospital Pharmacy

https://hal.archives-ouvertes.fr/hal-01392484

Pharmaceutical Technology in Hospital Pharmacy, 2016, 1 (2), pp.83-89. <https://www.degruyter.com/view/j/pthp.2016.1.issue-2/pthp-2016-0012/pthp-2016-0012.xml?format=INT>. <10.1515/pthp-2016-0012>

https://www.degruyter.com/view/j/pthp.2016.1.issue-2/pthp-2016-0012/pthp-2016-0012.xml?format=INT

Palavras-Chave #HPLC UV #ICH #Mitomycin C #Stability #stability indicating method #[SDV] Life Sciences [q-bio]
Tipo

info:eu-repo/semantics/article

Journal articles