Suboxone 8mg (Buprenorphine / Naloxone)

PRODUCT DESCRIPTION

Introduction

Suboxone 8mg is a pharmaceutical formulation combining buprenorphine and naloxone in an 8 mg to 2 mg ratio, respectively. It is available in the form of sublingual tablets or films designed to dissolve under the tongue for rapid systemic absorption. Suboxone is primarily used in research focusing on opioid dependence treatments, pharmacodynamics, and opioid receptor interactions. The product encompasses fixed dosage units with excipients and is intended strictly for research use in controlled environments, not for direct therapeutic application outside regulated clinical settings.

Chemical Properties and Specifications

Structural and Molecular Characteristics

• Active Ingredients: Buprenorphine hydrochloride and Naloxone hydrochloride dihydrate

• Buprenorphine Chemical Formula: C2929H4141NO44

• Buprenorphine Molecular Weight: 467.6 g/mol

• Naloxone Chemical Formula: C1919H2121NO44

• Naloxone Molecular Weight: 327.4 g/mol

• CAS Numbers: Buprenorphine – 53152-35-1; Naloxone – 465-65-6

• IUPAC Names:

  • Buprenorphine: (2S)-2-[(5R,6R,7R,14S)-9α-cyclopropylmethyl-4,5-epoxy-6-methoxy-17-methylmorphinan-7-yl]-3,3-dimethylbutan-2-ol

  • Naloxone: (4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,5,6,7,8,12b-hexahydro-4-methyl-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one

• Synonyms: Partial mu-opioid receptor agonist (buprenorphine), opioid antagonist (naloxone)

Physical Properties and Purity Standards

• Appearance: White hexagonal biconvex sublingual tablets approximately 11 mm in diameter, debossed with “N8”

• Purity: Pharmaceutical-grade purity ≥98% for both actives

• Excipients: Includes lactose monohydrate (approx. 168 mg per tablet), acesulfame potassium, citric acid anhydrous, magnesium stearate, maize starch, mannitol, natural lemon & lime flavor, povidone K30, and sodium citrate

• Solubility: Buprenorphine sparingly soluble in water and soluble in organic solvents; naloxone soluble in water and alcohol

• Storage Recommendations: Store at controlled room temperature (20-25 °C), protected from moisture and light

Pharmacological Profile and Mechanism of Action

Proposed Mechanism of Action

Buprenorphine acts as a partial agonist at the mu-opioid receptor, providing analgesic properties and opioid withdrawal symptom relief with a ceiling effect on respiratory depression, decreasing overdose risk relative to full agonists. It also exhibits antagonist activity at kappa-opioid receptors and modulates delta-opioid receptors.

Naloxone is a potent opioid receptor antagonist with high affinity for the mu-opioid receptor. When administered sublingually, naloxone has minimal bioavailability but serves to deter misuse by injection — if injected, naloxone blocks opioid effects and precipitates withdrawal.

Research Applications

Suboxone 8mg tablets are employed in studies exploring opioid addiction therapy, receptor binding dynamics, risk mitigation of opioid misuse, and pharmacokinetic-pharmacodynamic relationships. The combination is also examined in clinical pharmacology research focused on optimizing addiction treatment regimens and understanding the abuse-deterrent pharmaceutical design.

Comparative Analysis with Related Compounds

Comparison with Lower Dose Suboxone Formulations

Suboxone 8mg contains a higher concentration of buprenorphine and naloxone than the 2 mg/0.5 mg formulation, offering research models closer to maintenance doses in opioid dependence treatment. This enables studying dose-response effects, receptor saturation kinetics, and patient compliance in therapeutic drug monitoring research.

Advantages for Research

The fixed 4:1 buprenorphine to naloxone ratio provides a standardized formulation for examining dual agonist-antagonist pharmacodynamics. The higher dose formulation facilitates studies involving moderate to severe opioid dependence models and supports dosage optimization research.

Safety and Handling Guidelines

Laboratory Safety

Use personal protective equipment including gloves and eye protection when handling tablets. Avoid ingestion, inhalation, or skin contact. Conduct research under controlled conditions to prevent accidental exposure.

Disposal and Environmental Considerations

Dispose of unused or waste material in accordance with pharmaceutical hazardous waste regulations. Do not release into the environment as opioid components may cause ecological harm.

Regulatory Status

Suboxone 8mg is classified as a Schedule III controlled substance (varies by country), subject to strict regulation due to opioid content. It is approved for clinical use in opioid dependence treatment but restricted to licensed research facilities for experimental use.

Frequently Asked Questions (FAQs)

1. What is the buprenorphine to naloxone ratio in Suboxone 8mg?
   The ratio is 4:1, with 8 mg of buprenorphine and 2 mg of naloxone per tablet.

2. Why is naloxone added to Suboxone?
   To deter intravenous misuse by causing opioid withdrawal if injected.

3. How is Suboxone 8mg administered?
   Usually sublingually, the tablet dissolves under the tongue for absorption.

4. What are typical research uses for Suboxone 8mg?
   Studying opioid addiction treatment, pharmacodynamics, and abuse-deterrence mechanisms.

5. Is Suboxone 8mg safe to handle?
   It requires careful handling with PPE in research due to opioid activity and regulatory controls.

Conclusion

Suboxone 8mg is a critical high-dose sublingual combination of buprenorphine and naloxone used in research and clinical studies targeting opioid dependence therapy and pharmacology. Its formulation supports detailed exploration of opioid receptor partial agonist and antagonist interactions, abuse-prevention strategies, and dose-dependent effects. Safe laboratory practices and regulatory compliance are essential for its research utilization.