Source: FDA, National Drug Code (US) Revision Year: 2019
BUTRANS is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)].
The structural formula is:
The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C.
Five different strengths of BUTRANS are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream.
Table 6. BUTRANS Product Specifications:
| Buprenorphine Delivery Rate (mcg/hour) | Active Surface Area (cm²) | Total Buprenorphine Content (mg) |
|---|---|---|
| BUTRANS 5 | 6.25 | 5 |
| BUTRANS 7.5 | 9.375 | 7.5 |
| BUTRANS 10 | 12.5 | 10 |
| BUTRANS 15 | 18.75 | 15 |
| BUTRANS 20 | 25 | 20 |
BUTRANS is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded.
Figure 1. Cross-Section Diagram of BUTRANS (not to scale):
The active ingredient in BUTRANS is buprenorphine. The inactive ingredients in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate cross-linked with aluminum.
| Dosage Forms and Strengths |
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BUTRANS is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. BUTRANS is available in five strengths:
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| How Supplied |
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BUTRANS Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units. BUTRANS (buprenorphine) 5 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 45 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 5 mcg/hr and are supplied in a 4-count carton (NDC 59011-750-04). BUTRANS (buprenorphine) 7.5 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 58 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 7.5 mcg/hr and are supplied in a 4-count carton (NDC 59011-757-04). BUTRANS (buprenorphine) 10 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 68 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 10 mcg/hr and are supplied in a 4-count carton (NDC 59011-751-04). BUTRANS (buprenorphine) 15 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 72 mm by 59 mm. Each system is printed in blue with the BUTRANS logo and 15 mcg/hr and are supplied in a 4-count carton (NDC 59011-758-04). BUTRANS (buprenorphine) 20 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 72 mm by 72 mm. Each system is printed in blue with the BUTRANS logo and 20mcg/hr and are supplied in a 4-count carton (NDC 59011-752-04). Distributed by: Purdue Pharma L.P., Stamford, CT 06901-3431 Manufactured by: LTS Lohmann Therapy Systems Corp., West Caldwell, NJ 07006 |
| Drug | Countries | |
|---|---|---|
| BUTRANS | Canada, Germany, Ireland, Israel, Netherlands, Tunisia, United Kingdom, United States |
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