Preformulation Study of Dolasetron: An Insight for Formulation and Development of Nasal Formulation
Mansi
Rathod, Dharmik Mehta, Pragna Shelat, Punit Parejiya
ABSTRACT
The objective of
preformulation study is to develop the elegant, stable, effective and safe
dosage form by establishing kinetic profile, compatibility with other
formulation excipients and to establish physico-chemical parameter of new drug
substance. This could provide important information for formulation design or
support the need for molecular modification. So, in the present study
preformulation studies were performed on Dolasetron (DS) to assess its
suitability for nasal formulation. DS is a specific and selective serotonin
subtypes 3 (5-HT) receptor antagonists, used to treat chemotherapy induced nausea
and vomiting. The authenticity of DS was established by DSC and FITR spectra.
An UV spectrophotometric method and HPLC method were employed for determination
of DS in bulk and blood plasma respectively. Saturation solubility,
micromeritical properties, melting point, pH, hygroscopicity and stability
profile were studied. The UV method was linear in the range of 5-50 ?g/ml. The
low % CV values of intra-day and inter-day variations revealed that the
proposed method is robust. The retention time of DS in HPLC method was found to
be 2.8 min. The method was proven robust by obtaining very high regression
coefficient value (0.999). The results of the physicochemical study of drug
revealed suitability of DS for nasal route. Moreover, the drug was found stable
in both solid as well as liquid state at different conditions.
Keywords:
Preformulation, dolasetron, nasal formulation, bioavailability, stability