@article{
author = "Kovačević, Jovana and Kovačević, Aleksandar and Miletić, Tijana and Đuriš, Jelena and Ibrić, Svetlana",
year = "2022",
abstract = "Understanding the effect of the characteristics of formulation and process parameters on
the physicochemical properties of a pharmaceutical product is very significant for the
development of solid dosage forms, as the knowledge gained on small scale batches in the early
phase of development is used in the later phases of product lifecycle or in the development of
other products. One of the approaches for gaining a better understanding of the effects of the
formulation and production process on the quality of the finished product is to apply a
systematical approach which concerns performing experiments according to a predefined factorial
or fractional factorial experimental plan. However, often it is the case that there are available data
gathered in a non-systematic way, because experiments were not performed according to a
predetermined experimental plan. In such a case, data mining techniques could be used to extract
useful data from the historical data set. In this research, the possibility of using several data mining
techniques to build models that describe the effect of formulation characteristics on acid resistance
and dissolution profile of a model drug from gastro-resistant pellets. The model drug used in the
research is duloxetine hydrochloride from the group of antidepressants. It belongs to the BCS 2
class of active pharmaceutical ingredients, and it is therefore necessary for the release profile of
duloxetine to be characterized by a higher number of tested time points. The developed models
can be used for planning future laboratory trials, or in the development of other products., Razumevanje uticaja karakteristika formulacije i procesnih parametara na fizičkohemijske osobine farmaceutskog proizvoda je vrlo značajno u razvoju čvrstih doziranih oblika jer se znanje stečeno u fazi razvoja koristi i u svim sledećim fazama životnog ciklusa proizvoda, a može da se primeni i u razvoju drugih proizvoda. Jedan pristup ka postizanju boljeg poznavanja proizvoda i procesa je primena sistematičnog pristupa koji podrazumeva izvođenje eksperimenata u skladu sa predefinisanim faktorijalnim ili frakcionim faktorijalnim eksperiementalnim planom. Međutim, čest je slučaj da dostupni podaci nisu prikupljeni na sistematičan način zato što eksperimenti nisu izvođeni po predefinisanom planu. Tada se mogu primeniti tehnike istraživanja i analize podataka da bi se iz seta istorijskih podataka izdvojili korisni podaci. U ovom istraživanju smo ispitali mogućnost korišćenja različitih tehnika istraživanja i analize podataka za razvoj modela koji opisuju efekte formulacije na gastrorezistenciju i profil oslobađanja model supstance iz gastrorezistentnih peleta. Model supstanca je duloksetin hidrohlorid iz grupe antidepresiva. Pripada BCS 2 klasi lekovitih supstanci, te je poželjno da profil brzine rastvaranja duloksetina iz peleta bude okarakterisan većim brojem vremenskih tačaka. Razvijeni modeli se mogu koristiti za planiranje narednih proba ili u razvoju drugih proizvoda.",
publisher = "Pharmaceutical Association of Serbia",
journal = "Arhiv za farmaciju",
title = "Data mining techniques applied in the analysis of historical data, Tehnika istraživanja i analize podataka primenjena u analizi istorijskih podataka",
volume = "72",
number = "6",
pages = "701-715",
doi = "10.5937/arhfarm72-41368"
}
