April 27, 2017
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(buprenorphine and naloxone) Buccal Film


BUNAVAIL (buprenorphine and naloxone) buccal film is a citrus flavored oral transmucosal form of buprenorphine, an opioid partial agonist, and naloxone, an opioid antagonist, intended for application to the buccal mucosa. Each dose unit is a yellow rectangular film, with ink marking on the mucoadhesive side. The film adheres upon contact with the moist buccal mucosa. BUNAVAIL contains buprenorphine HCl, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid receptor antagonist, at a ratio of ~6:1 (ratio of free bases). It is available in three strengths: 2.1 mg buprenorphine with 0.3 mg naloxone in a 2.2 cm2 film; 4.2 mg buprenorphine with 0.7 mg naloxone in a 4.4 cm2 film; and 6.3 mg buprenorphine with 1 mg naloxone in a 6.5 cm2 film. Each film also contains carboxymethylcellulose sodium, citric acid, citrus blend flavor, dibasic sodium phosphate, blue ink, hydroxyethyl cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate, polycarbophil, propylene glycol, propylparaben, yellow iron oxide, sodium benzoate, sodium hydroxide, sodium saccharin, vitamin E acetate, and purified water. The blue ink contains FD&C blue #1, ethanol, purified shellac, acetone, ammonium hydroxide and water.

Chemically, buprenorphine HCl, USP is 6,14-Ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α,7α(S)]. It has the following chemical structure:

Buprenorphine HCl - Structural Formula Illustration 1

Buprenorphine HCl has the molecular formula C29H41NO4 ∙ HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate, USP is morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, hydrochloride, (5α)-, dihydrate. It has the following chemical structure:

Naloxone - Structural Formula Illustration 2

•HCl •2H2O

Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 • HCl • 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder, and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.

Last reviewed on RxList: 1/3/2017
This monograph has been modified to include the generic and brand name in many instances.

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