PHARMACEUTICAL COMPOSITIONS COMPRISING ACTIVE DRUGS, CONTRACEPTIVE KITS COMPRISING ACTIVE DRUGS, AND METHODS OF ADMINISTERING THE SAME

1 - 168 . (canceled)

169 . A method of providing contraception in a patient, the method comprising:

administering orally daily under a 28 consecutive day dosing regimen an active pharmaceutical composition comprising about 2 mg to about 6 mg of drospirenone and one or more pharmaceutically-acceptable excipients to said patient;

wherein said 28 consecutive day dosing regimen comprises:

administering said active pharmaceutical composition for 24 consecutive days followed by 4 consecutive days wherein no active pharmaceutical composition is administered to said patient; and

administering said active pharmaceutical composition daily at approximately the same time of day such that the interval between two dosages is approximately 24 hours;

wherein said pharmaceutical composition, when orally administered to said patient under fasting conditions, provides a pharmacokinetic profile for drospirenone having:

(i) a mean T max ranging from about 2.2 hours to about 6 hours;

(ii) a mean C max which is less than about 30 ng/ml; and

(iii) an AUC oh-tlast which is at least 300 ng·h/ml;

wherein the dissolution rate of said particle form of said drospirenone in said pharmaceutical composition is such that when subjected to an in vitro dissolution test according to the USP XXIII Paddle Method: no more than 50% of said drospirenone initially present in said pharmaceutical composition is dissolved within 30 minutes, and at least 50% of said drospirenone is dissolved in a time range from 3 hours to 4 hours; and

wherein said pharmaceutical composition does not contain an estrogen.

170 . The method of claim 169 , further comprising:

administering a placebo dosage unit during said 4 consecutive days wherein no active pharmaceutical composition is administered to said patient.

171 . The method of claim 170 , further comprising:

providing said active pharmaceutical compositions and said placebo dosage units in solid forms selected from the group consisting of: tablets, caplets, granules, pills, capsules, powders, and suspensions.

172 . The method of claim 171 , wherein said active pharmaceutical compositions and said placebo dosage units are both provided in tablet form.

173 . The method of claim 172 , wherein said active pharmaceutical composition tablets and said placebo dosage unit tablets further comprise a coating comprising a film-forming agent and one or more suitable excipients.

174 . The method of claim 173 , wherein said film-forming agent is selected from the group consisting of: hydroxypropylmethyl cellulose, hydroxypropryl cellulose, and ethyl cellulose.

175 . The method of claim 173 , wherein said one or more suitable excipients of said coating are selected from the group consisting of: softeners, fillers, and colorants.

176 . The method of claim 175 , wherein said colorants of said one or more suitable excipients of said coating are white for active pharmaceutical composition tablet coatings and green for said placebo dosage unit tablet coatings.

177 . The method of claim 169 , wherein said patient may miss one daily dosage of said active pharmaceutical composition within said 28 consecutive day dosing regimen, the method further comprising:

administering said missed dosage of said active pharmaceutical composition as soon as possible, but within about 24 hours; and

resuming said daily administration for the remaining days within said 28 consecutive day dosing regimen.

178 . The method of claim 169 , wherein said patient may miss 2 or more non-consecutive daily dosages of said active pharmaceutical composition within said 28 consecutive day dosing regimen, the method further comprising:

administering said missed dosages of said active pharmaceutical composition as soon as possible, but within about 24 hours; and

on each occasion, resuming said daily administration for the remaining days within said 28 consecutive day dosing regimen.

179 . The method of claim 169 , wherein said pharmaceutical composition is self-administered by said patient.

180 . The method of claim 169 , wherein said drospirenone is provided in particle form having a size distribution characterized by:

(i) a d 90 particle size of less than 100 μm;

(ii) a d 50 particle size in the range of about 10 μm to about 60 μm; and

(iii) a d 10 particle size of more than 3 μm.

181 . The method of claim 180 , wherein said drospirenone particles are obtained by a process consisting of: milling, crystallization, precipitation, sieve, or a combination thereof.

182 . The method of claim 181 , wherein said milling process comprises subjecting said drospirenone to one or more mills selected from the group consisting of: a fluid energy mill, a ball mill, a rod mill, a hammer mill, a cutting mill, and an oscillating granulator.

183 . The method of claim 169 , wherein said one or more pharmaceutically-acceptable excipients comprises talc, microcrystalline cellulose, anhydrous lactose, silicon dioxide, and magnesium stearate.

184 . The method of claim 169 , wherein said drospirenone is provided in an amount of about 4 mg.

185 . The method of claim 169 , wherein said pharmaceutical composition exhibits improved pharmacokinetics as compared to combined oral contraceptives containing drospirenone.

186 . The method of claim 185 , wherein said improved pharmacokinetics comprises one or more of the following: a delayed mean T max , a reduced mean C max , and a reduced mean AUC oh-tlast .

187 . The method of claim 169 , wherein said pharmacokinetic profile improves the tolerance of said drospirenone as compared to combined oral contraceptives containing drospirenone.

188 . The method of claim 187 , wherein said improved tolerance comprises a reduction in side-effects comprising one or more of the following: hyperkalemia, spotting, and irregular bleeding.

189 . The method of claim 169 , wherein said pharmacokinetic profile improves said patient's bleeding profile as compared to conventional progestogen-only contraceptives.

190 . The method of claim 189 , wherein said improved bleeding profile comprises a reduction in the incidence of unscheduled spotting and bleeding.