Description
Morphine Sulphate Sustained-Release (SR) Tablets (15 mg / 30 mg / 60 mg)
Healthy Inc is a specialized global supplier and exporter of advanced oncology-support, palliative care, and highly restricted central nervous system (CNS) therapeutics. We provide ultra-high-purity, kinetically controlled Morphine Sulphate Sustained-Release (SR) Film-Coated Tablets (15 mg / 30 mg / 60 mg), manufactured in WHO–GMP certified, highly secure, modified-release oral solid dosage facilities. This “Extended-Release Pure Mu-Opioid Agonist” is an ultra-high-value, strictly regulated export to oncology centers, hospice networks, specialized pain management clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, heavy-duty intervention for the management of severe, chronic, and intractable pain requiring daily, around-the-clock opioid treatment.
Product Overview
This highly advanced formulation takes the world’s oldest and most powerful natural analgesic and embeds it within a sophisticated polymer matrix, transforming a short-acting narcotic into a smooth, 12-hour continuous shield against agonizing terminal pain.
The “Mu-Opioid Blockade & 12-Hour Kinetic” Specialist:
- Mechanism 1 (The Central Pain Disconnect): Morphine is a pure opioid agonist that binds powerfully to mu-opioid receptors located throughout the brain and spinal cord. It fundamentally alters the central nervous system’s perception of and emotional response to pain. It violently inhibits the release of pain transmitters (like Substance P) and hyperpolarizes the neurons, completely severing the transmission of excruciating pain signals from the body to the brain.
- Mechanism 2 (The Sustained-Release Matrix Engine – CRITICAL): Standard immediate-release morphine lasts only 3 to 4 hours, forcing cancer patients into a miserable cycle of agonizing pain spikes followed by heavy, sedating drug peaks. Our SR formulation utilizes an advanced hydrophilic/lipophilic polymer matrix. As the tablet travels through the gut, the matrix slowly swells and releases the Morphine Sulphate at a highly calibrated, steady rate. This guarantees a smooth, unbroken 12-hour baseline of profound pain relief, allowing terminal patients to sleep through the night and maintain a dignified quality of life.
- The Palliative Care Gold Standard: In severe oncology settings (like late-stage bone metastasis), there is no “ceiling dose” for Morphine. The SR formulation allows oncologists to safely titrate the dosage upward over months, providing continuous, compassionate care when all other analgesics have failed.
Product Composition & Strength
We supply this product as a Precision-Blended, Extended-Release Matrix Tablet, packed exclusively in highly secure, tamper-evident Alu-PVC or Alu-Alu blister strips to ensure the absolute physical stability of the controlled-release polymers.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Morphine Sulphate USP/Ph.Eur. | 15 mg (SR) | Initiation / Titration Standard: Base therapeutic unit for opioid-naïve patients starting around-the-clock chronic pain management. |
| Morphine Sulphate USP/Ph.Eur. | 30 mg / 60 mg (SR) | Global Oncology Standard: High-dose adult maintenance therapy for severe, opioid-tolerant terminal cancer and intractable neuropathic pain. |
| Excipients | Hypromellose (HPMC) / Cetostearyl Alcohol / Lactose Monohydrate / Magnesium Stearate / Premium Color-Coded Film | Hydrophilic Polymer / Lipophilic Retardant / Diluent / Lubricant (Engineered specifically to form an impenetrable, slow-eroding gel matrix in the GI tract, strictly metering the release of the narcotic over 12 hours) |
*Pack Sizes: 10×10 Blisters (Optimized specifically for strict 30-day chronic oncology dispensing regimens; frequently color-coded by strength to prevent fatal dispensing errors).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Oncology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.40.00 (Medicaments containing alkaloids or derivatives thereof – Heavy Narcotics) |
| CAS Number | 64-31-3 (Morphine Sulfate) |
| Dosage Form | Sustained-Release Film-Coated Tablet (SR / ER) |
| Packaging | Tamper-Evident High-Density PVC/PVDC or Alu-Alu Blisters. Strict barrier packaging guarantees absolute matrix stability and meets international narcotic transport security protocols. |
| Storage | Store strictly below 25°C in a dry place. Protect heavily from Moisture. (Must be stored in a highly secured, strictly audited locked pharmacy vault). |
| Export Compliance Note (CRITICAL) | Schedule II Heavy Narcotic Control: Morphine is an internationally controlled substance tightly monitored by the International Narcotics Control Board (INCB). Export requires strict National Quota allocations, explicit Import Certificates from the destination country, and matched Export Authorizations from the Indian Central Bureau of Narcotics (CBN). |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Zero-Defect Matrix Engineering & Vault Security (CRITICAL COMPLIANCE): Manufacturing an SR heavy narcotic requires zero margin for error. If the polymer matrix fails and releases 60mg of Morphine instantly, the patient will die from respiratory arrest. Our facilities utilize elite fluid-bed granulation and high-shear matrix blending to guarantee flawless, 12-hour dissolution profiles. Furthermore, every milligram of API is tracked under continuous CCTV surveillance in reinforced concrete vaults, ensuring absolute regulatory compliance and zero diversion risk.
Therapeutic Indications (Human Use)
Indicated for the comprehensive, highly targeted management of severe pain:
- Severe Chronic Pain: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options (like NSAIDs or immediate-release opioids) are inadequate.
- Oncology & Palliative Care: The primary cornerstone therapy for terminal cancer pain and end-of-life hospice care.
- Note: NOT indicated for “as-needed” (PRN) pain relief or mild-to-moderate acute pain.
Dosage & Administration
Recommended Dosage (Strictly as per Oncology/Pain Specialist Guidelines):
- Standard Adult Dosing: Administered exactly every 12 hours. Dosage is highly individualized based on the patient’s prior opioid tolerance.
- The “Intact” Rule (FATAL WARNING): Tablets MUST be swallowed completely whole with enough water to ensure complete swallowing immediately after placing in the mouth. Crushing, chewing, or dissolving the tablet completely destroys the SR matrix, leading to the rapid release and absorption of a potentially FATAL dose of Morphine.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Addiction, Abuse, and Misuse): Morphine SR exposes patients and other users to the extreme risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
- BLACK BOX WARNING (Life-Threatening Respiratory Depression): Serious, life-threatening, or fatal respiratory depression may occur. The risk is highest during initiation of therapy or following a dosage increase.
- BLACK BOX WARNING (Accidental Ingestion): Accidental ingestion of even one dose of Morphine SR, especially by a child, can result in a fatal overdose.
- BLACK BOX WARNING (Interaction with CNS Depressants & Alcohol): Concomitant use with benzodiazepines (like Nitrazepam), alcohol, or other CNS depressants causes profound sedation, respiratory depression, coma, and death. Furthermore, consuming alcohol can prematurely dissolve the SR matrix in the stomach, causing massive, fatal “dose dumping.”
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Oncology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Sustained-Release and Controlled Narcotic Formulations. Whether you are looking for a reliable Government Tender Supplier for palliative care programs in the CIS or a B2B Pharma Marketplace partner for Latin America, our dedicated regulatory and logistics teams ensure the timely, fully licensed, and hyper-secure delivery of WHO-GMP certified products.
Reviews
There are no reviews yet.