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Pilot study: bioequivalence of dihydroartemisinin in dihydroartemisinin-piperaquine tablet generic formulation in healthy Indonesian volunteers

Isnawati, Ani Gitawati, Retno Alegantina, Sukmayati Setyorini, Herni Asih 名古屋大学

2023.05

概要

Malaria disease is still a problem in Indonesia. In 2018, from 514 regencies in Indonesia, there
are 285 regencies with malaria-free status, and 229 regencies especially in eastern Indonesia are
not yet gained malaria-free status. Based on blood examination in Indonesia Basic Health Survey
(Riskesdas) 2018, region with highest malaria is Papua 12.07% and West Papua 8.64% and East
Nusa Tenggara (NTT) 1.99%.1 Therefore malaria medicine is highly needed. Malaria treatment
with artemisinin combine based therapy (Artemisinin-based Combination Therapy, ACT) is the
best therapy for malaria that is recommended by WHO until now.2,3 One of ACT that is widely
used in Indonesia as first line malaria treatment and prospective in terms of safety and efficacy
is dihydroartemisinin-piperaquine (DHP) fixed-combination. This DHP is well tolerated with high
effectiveness to cure falciparum malaria with cure rate more than 95%, 3 days treatment with
follow up to 42 days.4-7 DHP tablet is imported product as well as all medicine ingredients in
Indonesia, estimated 95% is imported. To fulfill demand in Indonesia by producing local medicine,
quality test in vitro and in vivo are done to local DHP tablet.
In order to have good quality product and fulfill requirement as generic product, a series of
product quality test is needed that is comprised of physical test (tablet description, tablet weight
uniformity, tablet thickness, tablet hardness, tablet crispness) and chemical test (rate determination, dissolution, dissolution test profile compared to comparator).8 Generic medicine has also
run through clinical test, like innovator medicine before widely used. Implementing clinical
test to generic medicine needs high budget because it needs big sample to decide equivalent.
As alternative, bioequivalence (BE) test which has accurate endpoint (medicine rate in plasma)
is implemented. This test is used due to low variability, and few samples needed. If the two
bioequivalent medicines give the same effect, in terms of efficacy and safety, they can be act
as substitute and can be distributed in Indonesia.8
Thus, DHP tablet consist of 2 different chemical active substances, one of which is water
insoluble dihydroartemisinin (DHA) and the other piperaquine which is a water soluble substance.
The BE test has previously been carried out on the first formula using a parallel design. The
result is inequivalent.9 Therefore, in the BE test in this study, a pilot study of the active substance
DHA was carried out through reformulation of DHP tablet because this substance is a chemical
substance that is difficult to dissolve and difficult to absorb. ...

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参考文献

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