20.500.12556/DKUM-11086 OPTIMIRANJE TEHNOLOŠKEGA POSTOPKA IZDELAVE TABLET ZA ZDRAVLJENJE PLJUČNE TUBERKULOZE PROCESS OPTIMIZATION OF TABLETS PREPARATION FOR TREATMENT OF PULMONRY TUBERCULOSIS Predmet raziskovanja diplomske naloge je optimiranje tehnološkega postopka izdelave tablet za zdravljenje pljučne tuberkuloze v fazi granuliranja, s katerim želimo doseči v tehnološkem postopku predpisane meritve trdnosti in razpadnosti tablet v fazi tabletiranja. Začeli smo tako, da smo v fazi granuliranja v izdelek vgradili 12 kg purificirane vode pri 80% hitrosti vbrizgavanja granulirne tekočine. S tem postopkom smo v fazi tabletiranja izdelali tablete, ki so dajale neustrezno trdnost in zadovoljivo razpadnost. Nadaljevali smo z vgradnjo 13 kg purificirane vode pri enaki hitrosti vbrizgavanja granulirne tekočine, vendar smo na ta način izdelali tablete, ki so dajale ustrezno trdnost tablet in neustrezen, daljši čas razpadnosti tablet. V nadaljevanju smo spremljali lastnosti granulata pri vgradnji 13 kg purificirane vode pri 100% hitrosti vbrizgavanja granulirne tekočine, ki pa je v primerjavi s predhodnimi poizkusi dajal najboljše rezultate. Poizkusi so to tezo potrdili. Glede na rezultate postopkov izdelave smo predpostavili maksimalen čas trajanja mehanske operacije in maksimalen navor mešala v fazi granuliranja. Maksimalnih doseženih mehanskih parametrov pri postopku izdelave zdravila ne smemo prekoračiti. Nato smo želeli ugotoviti vpliv časa mešanja suhega granulata in pomožnih snovi pri pripravi zmesi za tabletiranje na trdnost in razpadnost tablet. Ugotovitve so pokazale, da čas homogenizacije v temu namenjenem mešalniku nima nikakršnega vpliva na trdnost in razpadnost tablet. Vpliv nastavitev tabletirnega stroja na kakovost tablet smo želeli dokazati tako, da smo nastavitve na tabletirnem stroju spreminjali in tako spremljali karakteristične parametre tablet. Rezultati so nam pokazali, da z večanjem sile stiskanja ne dosežemo višje trdnosti tablet in tako tudi predpisanega časa razpadnosti tablet. Po opravljeni raziskavi smo pridobljene rezultate prikazali tabelarično, ki nam bodo v prihodnje v pomoč pri izdelavi tega izdelka. The scope of this dissertation is the optimisation of granulation stage of the technological procedure for production of tablets, used for the medical treatment of pulmonary tuberculosis. The aim of this optimisation was to achieve the set requirements for hardness and disintegration of tablets in the tabletting stage. Our first experiment started with adding 12 kg of purificated water into the product in the granulation stage by injecting the granular liquid at 80% of speed. By doing so, we have achieved to produce tablets with corresponding disintegration, but they did not have the required hardness. In next step we added 13 kg of purificated water with the same injection speed of the granular liquid as in first experiment. In this case the tablets had the required hardness, but the disintegration was not within the set limits. Due to this, we have changed the characteristics of granulate by adding 13 kg of purified water with the injection of granular liquid at 100% of speed, which in comparison with previous experiments, gave us the best results. The test has confirmed this thesis. With the results obtained by experiments we were able to determine the maximal duration time of mechanical operation and maximal torque of the stirrer in the granulation stage. Determined maximal mechanical parameters should not be exceeded in the production of drug. Afterwards, we intended to establish how the stirring time, of a dry granulate and excipients in the preparation of tabletting mass, influences the hardness and disintegration of tablets. The results showed that time of homogenization in the stirrer does not affect the hardness and disintegration of tablets. We have also tried to demonstrate how the settings of the tabletting machine are affecting the quality of the product. The results showed that by increasing the pressing force, the tablet hardness is not increased tablet hardness and thus the prescribed time of tablet disintegration is not obtained. Finally, the results obtained in present work are summarized and presented in tabular form, wich offers a support for optimization of tablet production. The table demonstrates the influence of control parameters on the product characteristics in the granulation stage. mehanski postopki homogeniziranje granuliranje tabletiranje trdnost tablet razpadnost tablet mechanical procedures homogenization granulation tabletting hardness of tablets disintegration of tablets true true false [S. Ilič] Slovenski jezik Angleški jezik Diplomsko delo 2009-06-29 17:41:23 2009-12-22 09:35:09 2022-04-11 23:29:13 2022-04-17 03:29:48 2009 0 Maribor 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 [66.022.5:539.215]:615.453.5(043.2) 13326102 URN:SI:UM:DK:B338Y7X4 VS_Ilic_Sandra_2009.pdf VS_Ilic_Sandra_2009.pdf 1 30DA3AEC51D2A774B312372C4E120372 f00e080063053ef95a237eb684224d40b6e78e689d42b7f801c8059b2d7b056d 04d8bb75-7c03-11eb-bb7a-00155d0001ca 20.500.12556/dkum/de1f5793-8e47-4e45-90a0-e14ae3c587c5 https://dk.um.si/Dokument.php?lang=slv&id=9618 Fakulteta za kemijo in kemijsko tehnologijo 0 0 0