2210 preparation of self emulsifying tablets sets

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2.2.10. Preparation of Self-Emulsifying Tablets (SETs)Tablets of 177 mg weight were prepared using an instrumented press (8.0 mm flat-edged punches,Gamlen D-Series Press, Nottingham, UK) in the range 40–100 MPa at 3 mm/s compression rate.Force-displacement profiles were recorded during the compression and ejection stages. Ejectabilitywas taken as the maximum ejection force. Since preliminary experiments had shown that SEPs couldnot form good tablets on their own, they were compressed after mixing with 20%, 30%, and 40% Avicel101 and compressed at three compressions of 20, 40, and 60 MPa. The tableting experiments wereorganized in a small experimental design shown in Table3.Table 3.Composition (%) of self-emulsifying tablets and compression pressures applied fortheir preparation.Self-Emulsifying Pellets (SEPs)Avicel 101Compression (MPa)2080202080402080603070203070403070604060204060404060602.2.11. Evaluation of SETsThe weight of SETs before placing in the die for compression and of the ejected tablet after wipingwith filter paper were measured with accuracy±0.01 mg (New Classic MF, Mettler Toledo, Greifensee,Switzerland). No significant weight change was noticed to suggest leakage in the compression range20 to 60 MPa.Tablet porosity:The weight (Wt) and dimensions of tablets were measured with accuracy±0.001 g(UW 220 balance, Shimadzu Corporation, Kyoto, Japan) and±0.01 mm (Moore & Wright micrometer,Moore & Wright, Sheffield, UK) respectively. From the tablet volume (Vt) and the particle density Ps(g/cc) (taken as the weighted average of components obtained from the Handbook of PharmaceuticalExcipients) the porosity (%) was calculated from Equation (5).
Processes2019,7, 3657 of 22Tablet Porosity=1-[(Wt/Vt)/Ps)](5)Tensile strength and friability:Tablet tensile strength was determined by diametrical loading withthe apparatus that was used for compression (Gamlen D-Series Press, Gamlen Tableting, Nottingham,UK), but operated in fracture mode (10 Kg load cell).Tensile strength (T) was calculated fromEquation (6) [21]T=2Fπ/Φh(6)Fis the breaking load,Φthe tablet diameter andhits thickness. Friability was determinedaccording to USP 1216 using the apparatus described above for pellets (Copley Scientific, type FRV2000, Nottingham, UK) but after replacing the abrasion drum with the Roch design drum. Tabletsof about 6.5 g total weight were added to the drum and rotated for 5 min at 25 rpm. They weresubsequently removed and weighed. Friability was the %weight difference of tablets before andafter testing relative to original weight. Three measurements were taken and mean and standarddeviations calculated.2.2.12. In Vitro ReleaseDrug release studies were carried out using samples of self-emulsifying pellets, self-emulsifyingtablets and commercial tablets corresponding to 10 mg AtrCa. The tests were conducted in triplicate in900 mL of pH 1.2 or pH 6.8 medium at 75 rpm and 37±0.5C on a USP II apparatus (Sotax AG, Aesch,Switzerland) (n=3). Aliquots were removed at: 5, 10, 15, 30, 45, 60, 90, 120, 150, 180, 240 min timeintervals, filtered through a 0.45μm pore size membrane filter, diluted suitably and analyzed by HPLCat 237 nm [22].

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Term
Spring
Professor
RBLAND
Tags
Emulsion, SEPs, SEDDS

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