Source: FDA, National Drug Code (US) Revision Year: 2021
SUBLOCADE (buprenorphine extended-release) injection is a clear, viscous, colorless to yellow to amber, sterile solution for subcutaneous injection only. It is designed to deliver buprenorphine at a controlled rate over a one month period.
The active ingredient in SUBLOCADE is buprenorphine free base, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist.
Buprenorphine is dissolved in the ATRIGEL delivery system at 18% by weight.
The ATRIGEL delivery system is a biodegradable 50:50 poly(DL-lactide-co-glycolide) polymer and a biocompatible solvent, N-methyl-2-pyrrolidone (NMP).
SUBLOCADE is provided in dosage strengths of 100 mg and 300 mg. Table 5 presents the delivered amounts of the raw materials and the approximate delivered volume for the two dosage strengths.
Table 5. Amounts of Raw Materials and Delivered Volume for the Dosage Strengths:
| Raw Materials in SUBLOCADE | 100 mg Dosage | 300 mg Dosage |
|---|---|---|
| Buprenorphine | 100 mg | 300 mg |
| Poly(DL-lactide-co-glycolide) | 178 mg | 533 mg |
| N-methyl-2-pyrrolidone | 278 mg | 833 mg |
| Approximate Delivered Volume | 0.5 mL | 1.5 mL |
The molecular weight of buprenorphine free base is 467.6, and its molecular formula is C29H41NO4. Chemically, buprenorphine is (2S)2[17-(Cyclopropylmethyl)-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol.
The structural formula is:
| Dosage Forms and Strengths |
|---|
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SUBLOCADE is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is a clear, colorless to yellow to amber solution provided in a prefilled syringe with a 19 gauge 5/8-inch needle. |
| How Supplied |
|---|
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SUBLOCADE is available as a sterile, clear, viscous, colorless to yellow to amber solution in a single dose, prefilled syringe with safety needle. SUBLOCADE, 100 mg/0.5 mL – NDC 12496-0100-1 Manufactured for Indivior Inc., North Chesterfield, VA 23235 |
| Drug | Countries | |
|---|---|---|
| SUBLOCADE | Australia, Canada, Israel, New Zealand, United States |
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