Yaz Description

Each hormone-containing, light pink, film-coated tablet contains 3.0 mg drospirenone and 0.020 mg ethinylestradiol stabilized by betadex as a clathrate (molecular inclusion complex).
YAZ (drospirenone and ethinylestradiol) tablets are available in a 28-day regimen.
Drospirenone: Proper Name: drospirenone.
Chemical Name: 6β, 7β; 15β, 16β-dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone (IUPAC) [6R-(6α, 7α, 8β, 9α, 10β, 13β, 14α, 15α, 16α, 17β]-1,3',4',6,7,8,9,10,11,12,13,14,15,16,20,21-hexadecahydro-10,13-dimethylspiro[17H-dicyclopropa[6,7:15,16] cyclopenta[α]phenanthrene-17,2'(5'H)-furan]-3,5'(2H)-dione (USAN).
Molecular Formula: C₂₄H₃₀O₃.
Molecular Weight: 366.50.
Description: White to off-white crystalline powder. Freely soluble in dichloromethane; soluble in acetone, methanol, ethyl acetate, dimethoxyethane and toluene; sparingly soluble in ethanol; and practically insoluble in water, n-hexane and diisopropyl ether. Melting range is 199°C to 201°C.
pKa: Neutral molecule without any acid-base properties in aqueous solutions (pH 1 to 12).
Partition coefficient: log P_OW = 3.08.
Ethinylestradiol: Proper Name: ethinylestradiol (as betadex clathrate).
Chemical Name: 19-nor-17α-pregna-1,3,5(10)-triene-20-yne-3,17-diol,Bis(β-cyclodextrin-clathrate) (IUPAC).
Molecular Formula: C₁₀₄H₁₆₄O₇₂.
Molecular Weight: 2566.4.
Description: White to off-white powder. The aqueous solubility of ethinyl estradiol (as betadex clathrate) is 3.7 g/L. Due to decomposition, no melting point or range can be determined.
pKa: 10.51 ± 0.03.
Partition Coefficient: log P_OW = 3.38 (pH=5); 3.53 (pH=7); 3.20 (pH=9).
Excipients/Inactive Ingredients: Nonmedicinal ingredients for hormone-containing tablets: lactose monohydrate, maize starch, magnesium stearate, lacquer pink (or alternatively hypromellose 5 cP, talc, titanium dioxide and ferric oxide red).
Nonmedicinal ingredients for hormone-free tablets: cellulose microcrystalline, lactose monohydrate, magnesium stearate, hypromellose 5 cP, talc, titanium dioxide.