SPL Set ID: c2b08332-3256-4658-965a-ede3d973a388
1 drug(s) with this SPL Set ID
Doxycycline hyclate delayed-release tablets USP, for oral administration, contain specially coated pellets of doxycycline hyclate, USP, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate, USP is: The molecular formula is C 22 H 24 N 2 O 8 •HCl •½ C 2 H 6 O •½ H 2 O and a molecular weight of 512.9. The chemical name for doxycycline hyclate, USP is 4-(dimethylamino)-1,4,4α,5,5α,6,11,12α-octahydro-3,5,10,12, 12α-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacencarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate, USP is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 50 mg or 200 mg equivalent to doxycycline hyclate 57.7 mg or 230.8 mg, respectively. Inactive ingredients in the tablet formulation are: crospovidone, D&C Yellow #10 Aluminum Lake, hypromellose 2910, hypromellose phthalate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicified microcrystalline cellulose, talc, and triethyl citrate. USP Dissolution test pending. structural formula