Analiza nabrekanja in sproščanja iz ogrodnih tablet s hidroksipropil metilcelulozo v prisotnosti natrijevega lavrilsulfata in polisorbata 20

Prosen, Petra (avtor), Bogataj, Marija (mentor)

V magistrski nalogi smo preučevali nabrekanje in sproščanje iz ogrodnih tablet s hidroksipropil metilcelulozo v medijih pH vrednosti med 3 in 5, ki smo jim v različnih koncentracijah dodali eno od površinsko aktivnih snovi - anionski natrijev lavrilsulfat ali neionski polisorbat 20. Želeli smo preveriti, kako se interakcija med natrijevim lavrilsulfatom in hidroksipropil metilcelulozo odraža na sproščanju dobro in slabo vodotopne učinkovine (paracetamola oziroma natrijevega diklofenakata) in nabrekanju ogrodnih tablet s hidroksipropil metilcelulozo. Obnašanje tablet smo preučili še v medijih z dodanim polisorbatom 20, pri katerem interakcije s polimerom niso bile pričakovane. Nabrekanje tablet smo spremljali s sistemom s kamerami dissoGUARD® med poskusi sproščanja na napravi z vesli. Prav tako smo pri enakih pogojih spremljali tudi nabrekanje tablet brez učinkovine in rezultate primerjali z vrednostmi, dobljenimi pri testiranju tablet z učinkovinami. Tablete brez učinkovine smo po 4 urah v mediju tudi stehtali, da bi preučili spremembo mase tablet in rezultate povezali z rezultati nabrekanja. Rezultati sproščanja in nabrekanja kažejo na različne vplive izbranih površinsko aktivnih snovi. Interakcija med natrijevim lavrilsulfatom in hidroksipropil metilcelulozo se je odrazila na sproščanju, nabrekanju in spremembi mase ogrodnih tablet. Za sproščanje učinkovin v mediju z 0,05 % natrijevega lavrilsulfata je bil značilen nižji delež sproščenih učinkovin kot v mediju brez dodanih površinsko aktivnih snovi. Višje koncentracije natrijevega lavrilsulfata so sproščanje učinkovin izboljšale. Trend nabrekanja tablet je bil v obratni korelaciji s trendom sproščanja učinkovin. Značilna sta bila manjše nabrekanje in/ali večja erozija ogrodja tablet pri višjih koncentracijah natrijevega lavrilsulfata. Trend spremembe mase je v večini primerov sovpadal s trendom spreminjanja dimenzij tablet - bolj kot se je tableta povečala, večja je bila tudi njena masa. Nabrekanje tablet z natrijevim diklofenakatom je bilo v medijih z natrijevim lavrilsulfatom le v manjši meri odvisno od pH-vrednosti medija, topnosti učinkovine in solubilizacije, medtem ko so bili to pomembni dejavniki za hitrost sproščanja slabo topne učinkovine. Vpliv polisorbata 20 na nabrekanje tablet brez učinkovine in tablet s paracetamolom ni bil koncentracijsko odvisen, tablete so nabrekale nekoliko bolj kot v medijih brez dodanih površinsko aktivnih snovi, imel je tudi manjši vpliv na povečanje sproščanja obeh učinkovin v primerjavi z natrijevim lavrilsulfatom. V mediju pH 5 je polisorbat 20 sproščanje natrijevega diklofenakata upočasnil.

• Jezik: Slovenski jezik
• Ključne besede: interakcija, natrijev lavrilsulfat, hidroksipropil metilceluloza, nabrekanje, sproščanje
• Vrsta gradiva: Magistrsko delo/naloga
• Organizacija: FFA - Fakulteta za farmacijo
• Leto izida: 2019
• PID: 20.500.12556/RUL-109911
• Datum objave v RUL: 10.09.2019

Sekundarni jezik

• Jezik: Angleški jezik
• Naslov: Swelling and dissolution analysis of hydroxypropyl methylcellulose matrix tablets in presence of sodium lauryl sulfate and polysorbate 20

Izvleček

The purpose of this work was to study swelling and release behaviour from hydroxypropyl methylcellulose tablets in dissolution media of pH between 3 and 5 to which we added various concentrations of one of the surfactants - anionic sodium lauryl sulfate or nonionic polysorbate 20. We wanted to see how the interaction between sodium lauryl sulfate and hydroxypropyl methylcellulose reflects in the release of well and poorly water-soluble drugs (paracetamol or sodium diclofenac) and in the swelling of the matrix tablets with hydroxypropyl methylcellulose. The behaviour of the tablets was also studied in media with added polysorbate 20, in which interactions with the polymer were not expected. The swelling of the tablets was monitored with dissoGUARD® camera system during the dissolution tests on a paddle apparatus. The swelling of the tablets without a drug was also observed under the same conditions and the results were compared with those obtained from the tablets containing one of the drugs listed above. After 4 hours in a medium, the tablets without a drug were weighed in order to examine the change in tablet mass and correlate the results with the results of swelling. The results of the release and swelling indicate the different effects of selected surfactants. The interaction between sodium lauryl sulfate and hydroxypropyl methylcellulose was reflected in the release, swelling and changes in the mass of the matrix tablets. In the medium with 0.05% sodium lauryl sulfate lower amount of drug released than in media without added surfactants was observed. Higher concentrations of sodium lauryl sulfate have improved the release of the drugs. The trend of swelling of tablets was in reverse correlation with the trend of the release of the drugs. A minor swelling and/or greater erosion of the tablet matrix at higher concentrations of sodium laurylsulfate was distinctive. The trend of mass change in most cases coincided with the trend of changing the size of the tablets - the more the tablet enlarged, the greater the mass. The swelling of tablets with sodium diclofenac in media with sodium lauryl sulfate was only to a lesser extent dependent on pH value of medium, solubility of the drug and solubilization of the drug, while these were important factors for the release rate of the poorly soluble drug. The effect of polysorbate 20 on the swelling of tablets without drug and tablets with paracetamol was not concentration dependent, the tablets swelled slightly more than in media without added surfactants, and it also had smaller effect on increasing the release of both drugs compared to sodium lauryl sulfate. In media with pH 5 polysorbate 20 slowed down the release of sodium diclofenac.

• Ključne besede: interaction, sodium lauryl sulfate, hydroxypropyl methylcellulose, swelling, dissolution