Subutex (Buprenorphine) 8mg

PRODUCT DESCRIPTION

Introduction

Subutex 8mg is a pharmaceutical formulation consisting solely of buprenorphine hydrochloride, a semi-synthetic opioid used primarily for opioid dependence treatment and research. It is supplied as uncoated, white to off-white oval sublingual tablets designed for dissolution under the tongue, enabling systemic absorption. Subutex is utilized in clinical and research settings focusing on opioid addiction therapy, opioid receptor pharmacology, and treatment of chronic pain. The 8mg dosage strength is suitable for higher-dose research models requiring opioid receptor partial agonist investigation.

Chemical Properties and Specifications

Structural and Molecular Characteristics

• Chemical Formula: C2929H4141NO44·HCl

• Molecular Weight: 504.1 g/mol (buprenorphine hydrochloride)

• CAS Number: 71244-22-5

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

• Synonyms: Buprenorphine HCl, SUBUTEX

Physical Properties and Purity Standards

• Appearance: White to off-white, oval, uncoated sublingual tablets

• Purity: Pharmaceutical grade ≥98%

• Excipients: Lactose monohydrate, mannitol, cornstarch, povidone K30, citric acid, sodium citrate, magnesium stearate

• Solubility: Sparingly soluble in water (17 mg/mL), soluble in organic solvents such as ethanol

• 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 is a partial agonist at the mu-opioid receptor, providing analgesic effects and suppression of opioid withdrawal symptoms. Its binding exhibits high affinity and slow dissociation kinetics, leading to sustained receptor activation with a ceiling effect on respiratory depression and euphoria, reducing overdose risk compared to full agonists. It also acts as an antagonist or inverse agonist at kappa-opioid receptors and has weak agonist activity at delta-opioid receptors.

Research Applications

Subutex 8mg tablets are used in opioid dependence and addiction research to examine opioid receptor interactions, dosing effects, pharmacokinetics, and the efficacy of partial agonists in maintenance therapy. It serves as a model for studying opioid withdrawal suppression and overdose risk mitigation. Research also explores its analgesic properties and safety profile alongside other opioid therapies.

Comparative Analysis with Related Compounds

Comparison with Suboxone

Subutex contains only buprenorphine without the opioid antagonist naloxone, making it the preferred choice during induction phases of opioid dependence treatment to avoid naloxone-induced withdrawal. In research, this allows isolation of buprenorphine’s effects without interference from naloxone.

Advantages for Research

The pure buprenorphine formulation facilitates detailed study of opioid receptor partial agonism without antagonist interference. It is valuable for receptor pharmacodynamics, dose optimization, and comparison with combination therapies.

Safety and Handling Guidelines

Laboratory Safety

Handle with standard laboratory protective equipment including gloves and goggles to minimize exposure risk. Avoid ingestion and inhalation. Use in a well-ventilated area or fume hood as necessary for powder or tablet processing.

Disposal and Environmental Considerations

Dispose of unused tablets and waste according to pharmaceutical hazardous waste regulations. Prevent release into the environment and follow institutional controlled substance waste protocols.

Regulatory Status

Buprenorphine is a Schedule III controlled substance in many jurisdictions, regulated for research and clinical use due to its opioid effects and abuse potential. Subutex is approved for clinical use in opioid dependence therapy and restricted for experimental use in research settings.

Frequently Asked Questions (FAQs)

1. What is Subutex 8mg used for in research?
   Research related to opioid dependence treatment, opioid receptor pharmacology, and analgesia studies.

2. What is the difference between Subutex and Suboxone?
   Subutex contains buprenorphine alone; Suboxone combines buprenorphine with naloxone to deter misuse.

3. How is Subutex administered in research or clinical use?
   Sublingually, with tablets dissolving under the tongue for absorption.

4. What are the storage conditions?
   Controlled room temperature, protected from moisture and light.

5. Is Subutex safer than other opioids?
   It has a ceiling effect on respiratory depression, making it safer than full opioid agonists.

Conclusion

Subutex 8mg is a high-purity buprenorphine hydrochloride sublingual tablet used extensively in research and clinical settings for opioid dependence and pain management. Its partial agonist mechanism at opioid receptors reduces overdose risk, making it valuable for studying opioid maintenance therapy. Appropriate handling, storage, and regulatory adherence are essential for safe research use.