Rt

2-8°C, or at room temperature for <2 months

Table 1 List of Selected Commercially Available Lipid-Based Formulations for Oral Administration in the United States in 2005 (Continued)

Molecule/trade name/company/ date of initial marketing

Chemical structure

Indication

Dose

Type of formulation, strength

Lipid excipients and surfactants

Nonlipid excipients

Storage

Progesterone/ Prometrium®/ Solvay

Ritonavir'/ Norvir®/ Abbott/1999 in the U.K.

Hormone replacement therapy

HIV antiviral

Oral solution, Polyoxyl 40

80 mg/mL lopinavir and 20 mg/mL ritonavir

Soft gelatin capsule, 100, 200 mg micronized

Soft gelatin capsule, 100 mg hydrogenated castor oil (cremophor RH 40), peppermint oil

Peanut oil

Oleic acid, polyoxyl 35 castor oil (cremophor EL)

Alcohol (42.2% v/v), glycerin, propylene glycol, sodium chloride, sodium citrate, citric acid, water, and flavors/ sweeteners

None

BHT, ethanol

2-8°C, or at room temperature for <2 months

RT, protect from light and excessive moisture

Temperature for <1 month

Pediatrics 250-450 mg/m2 up to a maximum of 600 mg (< 7.5 mL) b.i.d.

Oral solution, 80mg/mL

Saquinavir/ Fortovase™/ Roche/1998 in the U.K. Discontinued in 2006 (14)

Sirolimus/ Rapamune®/ Wyeth-Ayerst/ 2001 in the U.K.

Tipranavir/ Aptivus®/ Boeliringer Ingelheim/

HIV antiviral

Immunosuppressant

HIV antiviral

1200mg (6 capsules) t.i.d. without ritonavir; 1000mg (5 capsules) b.i.d. with ritonavir 6mg (6mL) loading dose followed by 2mg (2mL) q.d.

capsules) with ritonavir 200 mg b.i.d.

Soft gelatin capsule, 200 mg

Polyoxyl 35 Ethanol (43%), castor oil water, propylene

(cremophor EL) glycol, citric acid, sweetener, dye flavors.

Soft gelatin capsule, 200 mg

Oral solution, 1 mg/mL

Medium-chain mono- and diglycerides, dl-a-tocopherol

Phosal 50 PG® (phosphatidylcholine, mono- and diglycerides, soy fatty acids, ascorbyl palmitate), polysorbate 80 Polyoxyl 35 castor oil (cremophor EL), medium-chain mono-and diglycerides

Povidone

Phosal 50 PG® (propylene glycol, ethanol 1.5-2.5%)

Ethanol (7% w/w or 0.1 g per capsule), propylene glycol

2-8°C, or at room temperature for <3 months

2-8°C, or at room temperature for <15 days

2-8°C prior to opening the bottle, room temperature for <60 days

Molecule/trade name/company/ date of initial marketing

Chemical structure

Indication

Dose

Type of formulation, strength

Lipid excipients and surfactants

Nonlipid excipients

Storage

Tolterodine tartrate/Detrol® LA/Pharmacia & UpJohn/2001 in the U.K.

Tretinoin/ Vesanoid®/ Roche/2001 in the U.K.

Overactive

bladder— muscarinic receptor antagonist

Antineo-plastic

2-4 mg q.d. Extended Medium-chain

(1 capsule) release hard triglycerides.

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