Description
Minocycline Hydrochloride Extended-Release Tablets (50 mg / 100 mg)
Healthy Inc is a specialized global supplier and exporter of advanced dermatological, anti-infective, and immunomodulatory therapeutics. We provide ultra-high-purity, kinetically stabilized Minocycline Hydrochloride Extended-Release (ER) Film-Coated Tablets (50 mg / 100 mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Highly Lipophilic Tetracycline” is a massive-volume, high-margin export to dermatology clinics, infectious disease centers, rheumatology networks, and retail pharmacy chains in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally trusted intervention for severe inflammatory Cystic Acne, Community-Acquired MRSA, and Rheumatoid Arthritis.
Product Overview
This highly advanced formulation utilizes a second-generation, broad-spectrum tetracycline derivative that possesses unique anti-inflammatory properties and unparalleled tissue penetration, making it effective where water-soluble antibiotics fail.
The “Sebaceous Penetrator & Vestibular-Shield” Specialist:
- Mechanism 1 (The Ribosomal Blockade): As a potent antibiotic, Minocycline enters the bacterial cell and irreversibly binds to the 30S ribosomal subunit. This physically blocks the binding of aminoacyl-tRNA to the mRNA-ribosome complex, completely halting bacterial protein synthesis and stopping the multiplication of Cutibacterium acnes (the primary bacteria driving acne).
- Mechanism 2 (The Lipophilic Advantage): Unlike older tetracyclines, Minocycline is highly fat-soluble. When a patient takes the tablet, the drug aggressively concentrates in the lipid-rich sebum of the hair follicles and sebaceous glands. It literally swims through the skin’s oil to reach deep, painful cystic acne nodules that topical creams cannot touch.
- Mechanism 3 (The Inflammatory Quencher): Beyond killing bacteria, Minocycline acts as a profound immunomodulator. It actively inhibits pro-inflammatory cytokines, matrix metalloproteinases (MMPs), and neutrophil migration. This rapid reduction in systemic inflammation makes it a highly effective off-label therapy for Autoimmune conditions like Rheumatoid Arthritis.
- The Extended-Release Necessity: Immediate-release Minocycline violently crosses the blood-brain barrier, causing sudden, severe dizziness, vertigo, and ringing in the ears (vestibular toxicity), particularly in young women. Our ER formulation utilizes a slow-release polymer matrix to flatten the pharmacokinetic curve. By avoiding the sharp “Cmax spike,” the patient receives all the acne-clearing benefits with virtually zero dizziness.
Product Composition & Strength
We supply this product as a Precision-Blended, Hydrophilic Matrix ER Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips or opaque HDPE bottles to ensure the absolute chemical stability of the photosensitive hydrochloride salt.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Minocycline (as Hydrochloride) USP/Ph.Eur. | 50 mg (ER) | Dermatology Maintenance Standard: Long-term, low-dose therapy for controlling inflammatory acne and severe Rosacea with minimal side effects. |
| Minocycline (as Hydrochloride) USP/Ph.Eur. | 100 mg (ER) | Acute Clearance Standard: High-dose therapy for severe cystic acne breakouts, CA-MRSA skin infections, and Rheumatoid Arthritis flares. |
| Excipients | Hypromellose (HPMC) / Microcrystalline Cellulose / Magnesium Stearate / Premium Opaque Opadry Film | Hydrophilic ER Polymer / Diluent / Lubricant / UV-Blocking Coating (Engineered specifically to pace the gastric release over several hours, preventing the rapid blood-brain-barrier saturation that triggers vertigo) |
*Pack Sizes: 10×10 Alu-Alu Blisters or Bottles of 30 (Optimized specifically for strict 12-to-16 week chronic dermatology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Dermatology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.20.99 (Medicaments containing other antibiotics – Tetracycline Class) |
| CAS Number | 13614-98-7 (Minocycline Hydrochloride) |
| Dosage Form | Extended-Release Film-Coated Tablet (ER) / Immediate-Release capsules also available upon specification. |
| Packaging | Heavy-Gauge Alu-Alu Blisters or Opaque HDPE Bottles. Minocycline is highly sensitive to moisture and light. Strict barrier packaging guarantees absolute chemical stability and prevents degradation across Zone IVb tropical climates. |
| Storage | Store strictly below 25°C in a dry place. Protect heavily from Moisture and Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Vestibular Toxicity Mitigation & Polymer Engineering (CRITICAL COMPLIANCE): The commercial success of Minocycline in the lucrative dermatology market hinges entirely on tolerability. Our facilities utilize advanced high-shear granulation to embed the highly soluble Minocycline into a precise Hypromellose (HPMC) matrix. This guarantees the exact pharmacokinetic release profile required to keep blood levels steady, delivering massive clinical efficacy while entirely bypassing the central nervous system side effects that plague cheap generic formulations.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly effective management of severe inflammatory and bacterial conditions:
- Severe Acne Vulgaris: The first-line oral therapy for moderate to severe inflammatory acne that is unresponsive to topical therapies.
- Community-Acquired MRSA (CA-MRSA): Highly effective oral step-down therapy for resistant skin and soft tissue infections.
- Rheumatoid Arthritis (Off-Label / DMARD): Used as a disease-modifying antirheumatic drug to reduce joint swelling and tenderness.
- Atypical Infections: Treatment of Chlamydia, Mycoplasma pneumonia, and certain sexually transmitted infections when standard therapies are contraindicated.
Dosage & Administration
Recommended Dosage (Strictly as per Dermatologist Guidelines):
- Standard Adult Dosing (Acne): 50 mg to 100 mg taken orally once or twice daily.
- Administration (THE UPRIGHT RULE): To prevent severe esophageal ulceration and burning, tablets MUST be swallowed with a full glass of water, and the patient must remain upright for at least 30 minutes after dosing.
- The Chelation Warning: Like all tetracyclines, Minocycline violently binds to multivalent cations. It must be taken at least 2 hours before or 4 hours after dairy products (calcium), antacids (magnesium/aluminum), or iron supplements.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX EQUIVALENT (Tooth & Bone Malformation): Strictly contraindicated during pregnancy (teratogenic) and in children under the age of 8. It causes permanent, severe blue-gray discoloration of developing teeth and physically retards skeletal bone growth.
- The “Blue-Gray” Hyperpigmentation: Chronic, long-term use (often seen in Rheumatoid Arthritis patients) can cause a highly specific, irreversible blue, gray, or muddy-brown staining of the skin, nails, sclera (whites of the eyes), and even the thyroid gland.
- Vestibular Toxicity: Can cause sudden, severe dizziness, lightheadedness, and vertigo. Patients should be warned about driving or operating heavy machinery during the first week of therapy.
- Drug-Induced Lupus & Autoimmune Hepatitis: Rare but severe risk of triggering lupus-like syndromes or severe liver injury. Therapy must be stopped immediately if joint pain, unexplained fever, or jaundice occurs.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Dermatology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Dermatological, Antibiotic, and Extended-Release Formulations. Whether you are looking for a reliable Private Label Supplier for aesthetic clinics in Southeast Asia or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.









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