Description

Epalrestat Sustained Release (SR) Film-Coated Tablets (150 mg)

Healthy Inc is a specialized global supplier and exporter of advanced diabetology, neurology, and targeted metabolic therapeutics. We provide ultra-high-purity, kinetically stabilized Epalrestat Sustained Release (SR) Film-Coated Tablets (150 mg), manufactured in WHO–GMP certified, high-precision polymer-matrix oral solid dosage facilities. This “Aldose Reductase Inhibitor & Neuropathy Modifier” is a massive-volume, highly strategic export to diabetic care networks, endocrinology centers, neurology clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, disease-modifying intervention for Diabetic Peripheral Neuropathy (DPN).

Product Overview

This highly advanced formulation operates fundamentally differently than standard painkillers. Instead of acting as a neurological “mute button” for pain, it intervenes at the cellular level to halt the toxic metabolic cascade that destroys diabetic nerves, promoting actual physiological repair of the myelin sheath and nerve fibers.

The “Aldose Reductase Inhibitor & SR Compliance” Specialist:

• Mechanism 1 (The Aldose Reductase Blockade): In chronic diabetes, high blood sugar forces glucose into the “polyol pathway.” An enzyme called Aldose Reductase converts this excess glucose into a toxic sugar alcohol called Sorbitol. Because Sorbitol cannot easily exit the nerve cells, it accumulates, causing severe cellular swelling, oxidative stress, and the physical destruction of the nerve. Epalrestat violently and reversibly inhibits Aldose Reductase, completely cutting off the production of toxic Sorbitol.
• Mechanism 2 (Metabolic Nerve Rescue): By draining the nerve of accumulated Sorbitol, Epalrestat restores normal intracellular transport and Na+/K+ ATPase activity. This physically rescues the dying neuron, clinically restoring the patient’s lost vibratory sensation, reducing numbness, and arresting the progression of agonizing burning pain in the extremities.
• Mechanism 3 (The Sustained Release Paradigm): The standard half-life of immediate-release Epalrestat is exceptionally short, requiring patients to take it three times a day. Our Sustained Release (SR) formulation utilizes a complex hydrophilic polymer matrix to slowly and evenly drip-feed the API into the bloodstream over 24 hours. This slashes the pill burden to just once daily, guaranteeing massive improvements in chronic patient compliance.

Product Composition & Strength

We supply this product as a Precision-Blended, Photostable SR Matrix Tablet, packed exclusively in highly secure, light-blocking Alu-Alu blister strips to ensure the absolute chemical survival of the intensely photolabile molecule.

*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict 3-to-6 month chronic diabetic dispensing regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Endocrinology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Photostable Engineering & SR Matrix Control (CRITICAL COMPLIANCE): The engineering challenge of Epalrestat SR is twofold. First, our diabetology suites must utilize strict amber-lighting and immediate, heavy-gauge titanium dioxide film-coating to prevent UV degradation on the factory floor. Second, compressing 150mg of API into an HPMC matrix requires exacting granulation to ensure the tablet does not “dose dump” (release all the drug at once), but rather maintains a perfect 24-hour dissolution curve. We guarantee absolute pharmacokinetic precision and long-term shelf stability.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized metabolic management of diabetic complications:

• Diabetic Peripheral Neuropathy (DPN): Improvement of subjective symptoms (burning pain, numbness, hyperesthesia) and objective findings (loss of vibratory sense, abnormal nerve conduction velocity) associated with peripheral polyneuropathy in diabetic patients.
• Prophylactic Diabetic Care: Utilized in early-stage diabetes to aggressively prevent the structural onset of neuropathic and microvascular damage.

Dosage & Administration

Recommended Dosage (Strictly as per Endocrinologist Guidelines):

• Standard Adult Dosing (SR): 150 mg taken orally once daily.
• Administration: Must be taken before a meal to maximize systemic absorption and optimize the 24-hour release profile. Tablets must be swallowed whole and NEVER crushed, chewed, or broken, as this destroys the sustained-release matrix and causes immediate dose-dumping.
• Duration of Trial: If no clinical improvement in neurological symptoms is observed after 12 weeks of continuous therapy, the drug should be discontinued, as the nerve damage may be irreversible.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Hepatic Function Monitoring: Epalrestat is heavily metabolized by the liver. It can cause severe elevations in AST/ALT and profound hepatic dysfunction. Routine Liver Function Tests (LFTs) are highly recommended during long-term therapy.
• Red / Brown Urine (Harmless Harmless Side Effect): Epalrestat metabolites frequently completely change the color of the patient’s urine to an intense, dark reddish-brown. Patients must be explicitly warned of this harmless effect so they do not panic and assume their kidneys are bleeding or failing.
• Irreversible Neuropathy Limitation: Endocrinologists must be aware that Epalrestat is highly effective in early-to-moderate neuropathy. It is largely ineffective in patients who have already suffered total, irreversible nerve death.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Diabetology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Neuropathy Modifiers, Aldose Reductase Inhibitors, and Photostable SR Formulations. Whether you are looking for a reliable Government Tender Supplier for diabetic clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.