Formulation of Dihydroartemisinin-Piperaquine (DHP) Generic Tablet as Antimalarials Drug
Abstract: The incidence of
malaria in Indonesia is about two million cases annually.
Dihydroartemisinin-piperaquine (DHP) is the first line therapy recommended for
uncomplicated malaria treatment, whereas DHP is still fully imported. The generic
DHP tablet formulation has the potential to become the first of DHP drug which
is locally produced. This study is aimed to formulate generic DHP film coated
tablets for antimalaria drug. Tablets were compressed with the combination of
wet granulation for piperaquine phosphate (PQP) and direct compression method
for DHA and coated with a moisture barier coating material. The parameters to
evaluate the quality of DHP tablets are physical properties, assay, and
dissolution test. DHA and PQP assay were performed by HPLC method. The
dissolution testing was conducted by in house method using HCl 0.1 N medium.
The result shows physical properties of filmcoated tablets meet the
requirement, i.e. uniform weight, 7.0-8.5 kp hardness, 0.02% friability and 3
minute 22 seconds disintegration. The assay to determine DHA in tablet was
95.17% and PQP was 97.05%. The result of dissolution testing shows the content
of DHA and PQP in the tablet were 113.51% and 96.55%, respesctively. The formulation
which is developed meets the general requirement of API in tablet 90–110% and
dissolution requirement >75%.
Keywords: Dihydroartemisinin;
Piperaquine; Tablets; Film coated
Penulis: Nanang Yunarto, Ani
Isnawati, Nurul Aini, Arifayu Addiena Kurniatri,
Kode Jurnal: jpfarmasidd160732
