BILAYER TABLETS FOR THE PURPOSE OF OBTAINING SUITABLE TABLET SUBDIVISIONS

Tablets can be subdivided by patients for several reasons.However, these subdivisions are not guaranteed to produce acceptable splits using the known subdivision techniques.The main objective of this study is to evaluate the use of bilayer tablets to obtain suitable tablet subdivisions.Bilayer tablets of two formulations were evaluated.The bilayer tablets were produced by compaction of 250 mg of powder at 43 MPa followed by compaction of an additional 250 mg of the same powder at 43 MPa.Each of the evaluated bilayer tablets was either composed of microcrystalline cellulose (MCC) or a mixture of MCC and caffeine.Subdivisions were performed by pressing the metal tip of a lancet on the edge of the bilayer tablet at the interface between the layers.Properties of the bilayer tablets and the subdivided layers were determined.Furthermore, the friability of the bilayer tablets was tested.It was found that the produced bilayer tablets lost less than 1% of their weight and did not delaminate during the friability test.Moreover, it was found that two almost intact tablets were subdivided from each bilayer tablet.The weight of each subdivision was close to 50% of the weight of the whole bilayer tablet.The standard deviations of the percentage weights of the subdivisions were less than or equal to 0.15%.Therefore, it was possible to subdivide bilayer tablets to produce tablet splits with relatively high accuracy and precision. RezumatObiectivul principal al acestui studiu a fost de a evalua utilizarea comprimatelor bistratificate pentru a obine subdiviziuni adecvate.Au fost evaluate tablete bistrat din dou formulri farmaceutice.Tabletele cu dou straturi au fost produse prin compactarea a 250 mg de pulbere la 43 MPa urmat de compactarea a nc 250 mg din aceeai pulbere la 43 MPa.Fiecare dintre comprimatele cu dou straturi evaluate a fost compus fie din celuloz microcristalin (MCC), fie dintr-un amestec de MCC i cafein.Subdiviziunile au fost efectuate prin apsarea vrfului metalic al lancetei pe marginea tabletei, la interfaa dintre straturi.Au fost determinate att proprietile comprimatelor bi-strat ct i ale straturilor subdivizate.n urma determinrii friabilitii, s-a concluzionat c aceste comprimate bistratificate obinute au pierdut mai puin de 1% din greutate i nu s-au delaminat.Greutatea fiecrei subdiviziuni a fost aproape de 50% din greutatea ntregului comprimat.Abaterile standard ale ponderilor procentuale ale subdiviziunilor au fost mai mici sau egale cu 0,15%.