Ivermectin + Albendazole Suspension
Ivermectin IP and Albendazole IP Oral Suspension · Anti-Infectives, Gastroenterology, Infectious Diseases
SUSPENSION PRESENTATION:
Product Profile
Ivermectin and Albendazole Oral Suspension represents a highly potent, broad-spectrum, synergistic anthelmintic (anti-parasitic) intervention. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech employs advanced micronization and co-suspension technologies to ensure that these two poorly water-soluble active pharmaceutical ingredients (APIs) are perfectly homogenized. This guarantees maximum pediatric bioavailability, exact dose uniformity, and exceptional clinical efficacy against complex, mixed helminthic infections.
DCGI Approved
Comprehensive documentation and CDSCO support for rapid market entry in India.
Fast Turnaround
30-45 days lead time for new batches with state-of-the-art logistics.
Pan-India Supply & Contract Manufacturing
Description & Therapeutic Class
This proprietary multi-salt formulation is classified as a synergistic Anthelmintic and Microfilaricidal agent. It combines a macrocyclic lactone (Ivermectin) with a benzimidazole derivative (Albendazole). It is primarily indicated for mass drug administration (MDA) programs and the targeted pediatric treatment of soil-transmitted helminthiases (STH), strongyloidiasis, filariasis, and severe scabies.
Because both parasiticides have vastly different chemical structures and poor aqueous solubility, formulating them into a stable Suspensions format requires immense pharmaceutical expertise. By utilizing an advanced liquid dispersion matrix and premium taste-masking agents, Saar Biotech ensures that the inherently chalky APIs are highly palatable, maximizing pediatric compliance in both clinical and community health settings.
Pan-India Supply & Contract Manufacturing
The Saar Biotech Advantage
The clinical failure of many anthelmintic suspensions is directly tied to poor API dispersion and rapid sedimentation. Saar Biotech operates a dedicated, state-of-the-art liquid manufacturing facility located in the pharmaceutical hub of Baddi, Himachal Pradesh.
Our specialized manufacturing lines utilize high-shear homogenization to drastically reduce the particle size of both the Ivermectin and Albendazole crystals. We incorporate specialized wetting agents and thixotropic polymers to create a suspension that remains perfectly deflocculated while resting on the shelf, yet pours smoothly when agitated. Our rigid Quality Control (QC) protocols rigorously test every batch for exact API concentration, pH stability, and absolute microbial purity, making us the trusted third-party manufacturing partner for government tenders and elite B2B marketing brands.
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Key Indications & Clinical Use
The combination of Ivermectin and Albendazole is highly prescribed across pediatric and adult populations for the aggressive eradication of complex, mixed, or highly resistant parasitic infections.
- Soil-Transmitted Helminthiases (STH): The primary indication. Highly effective against ascariasis (roundworm), trichuriasis (whipworm), and hookworm infections, which are major causes of pediatric malnutrition and anemia.
- Lymphatic Filariasis: Utilized globally in mass drug administration (MDA) programs to rapidly clear microfilariae from the blood, preventing transmission.
- Strongyloidiasis: First-line intervention for Strongyloides stercoralis infections, targeting both the adult worms in the intestine and the migrating larvae in the tissue.
- Resistant Scabies & Pediculosis: Often utilized off-label or in severe, crusted (Norwegian) scabies cases where topical permethrin alone has failed, providing systemic eradication of the infesting mites.
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Mechanism of Action & Manufacturing Integrity
Synergistic Dual-Action Mechanism
The phenomenal clinical efficacy of this suspension is driven by the fact that both APIs attack the parasite’s nervous system and cellular structure through entirely different, synergistic pathways:
- Ivermectin (The Paralyzer): A highly potent macrocyclic lactone. It selectively and irreversibly binds to glutamate-gated chloride ion channels found exclusively in invertebrate nerve and muscle cells. This binding forces the channels to remain open, causing a massive influx of chloride ions. This leads to profound hyperpolarization of the nerve/muscle cell, resulting in flaccid paralysis and the rapid death of the parasite.
- Albendazole (The Starver): A broad-spectrum benzimidazole. It acts intracellularly by binding to the parasite’s free beta-tubulin, permanently inhibiting its polymerization into microtubules. This causes a complete collapse of the parasite’s internal cellular transport system, preventing the uptake of glucose. The parasite effectively starves to death, and its stored glycogen is rapidly depleted. Furthermore, Albendazole exhibits powerful ovicidal (egg-killing) properties, breaking the reproductive cycle.
Manufacturing Integrity
Albendazole is notoriously insoluble in water and absorbs poorly in the human gut. Saar Biotech overcomes this pharmacokinetic hurdle by utilizing highly micronized Albendazole and formulating it alongside specific lipophilic co-solvents and surfactants. This drastically increases its specific surface area, allowing for significantly higher dissolution rates upon entering the gastric fluid. Ivermectin is highly sensitive to oxidative degradation; therefore, we manufacture the suspension under inert nitrogen sparging and utilize specific antioxidant buffering systems to protect the molecular integrity of the macrocyclic lactone ring throughout the product’s shelf life.
Pan-India Supply & Contract Manufacturing
Pharmacokinetics & B2B Commercial Value
Absorption & Distribution
The pharmacokinetics of this suspension are highly dependent on the presence of dietary fat.
- Ivermectin: Rapidly absorbed following oral administration, reaching peak plasma concentrations within 4 hours. It is widely distributed to tissues but does not cross the intact blood-brain barrier in humans, ensuring systemic safety.
- Albendazole: Poorly absorbed from the GI tract due to its low aqueous solubility. However, our specialized suspension matrix enhances baseline absorption. Crucially, when administered with a fatty meal, the systemic absorption of Albendazole increases by up to 5-fold. It rapidly undergoes extensive first-pass metabolism in the liver to its active primary metabolite, albendazole sulfoxide, which is responsible for its systemic tissue-penetrating anthelmintic activity.
Both drugs are primarily metabolized in the liver and excreted almost entirely in the feces, with a minor fraction appearing in the urine.
Commercial Viability
For our B2B partners, the Ivermectin + Albendazole combination represents one of the highest-velocity pediatric products in the infectious disease market. The “single-dose” or “short-course” regimen required for most helminthic infections guarantees rapid turnover and incredibly high patient compliance. Marketing companies can capitalize on the unique, broad-spectrum “Paralyze and Starve” narrative. Furthermore, our highly stable, perfectly taste-masked formulation ensures tremendous brand loyalty among pediatricians and parents, making it an incredibly lucrative addition to any pediatric portfolio.
Pan-India Supply & Contract Manufacturing
B2B & Contract Manufacturing Details
Saar Biotech provides complete, end-to-end third-party manufacturing and contract packaging solutions for Ivermectin and Albendazole Suspensions, tailored to exact B2B specifications.
- Standardized Strength Formulation: Formulated to precise, globally recognized standards to ensure accurate weight-based dosing for pediatric patients.
- Packaging Customizability: We provide 10ml, 15ml, and 30ml PET or glass bottle options, equipped with child-resistant caps (CRC) and highly accurate measuring cups.
- Flavor Engineering: Recognizing that palatability is critical, we offer a vast library of taste-masked flavor profiles, including Strawberry, Mango, and Mixed Fruit, to completely neutralize the chalky taste of the APIs.
- Regulatory Support: Our internal compliance team assists with CDSCO/DCGI documentation, Legal Metrology compliance for carton artworks, and the generation of comprehensive Certificates of Analysis (COA) for every batch.
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Storage & Handling Guidelines
To preserve the clinical efficacy and physical stability of the formulation, the suspension should be stored in a cool, dry environment, strictly below 30°C. It must be protected from direct sunlight, which can cause photodegradation of both the active ingredients and the flavoring agents. Do not freeze the suspension, as this will permanently alter the rheological properties of the suspending agents and cause the APIs to precipitate. Patients must be instructed to shake the bottle vigorously before every use to ensure complete homogenization of the dose. It is generally recommended to be taken with food, particularly a fatty meal, to maximize the systemic absorption of Albendazole if tissue-dwelling parasites are being targeted.
Pan-India Supply & Contract Manufacturing
Quality Control & Compliance
Saar Biotech’s commitment to pharmaceutical excellence is absolute. Every batch of this complex dual-suspension is subjected to a rigid battery of analytical tests within our GLP-certified laboratories prior to release.
- Simultaneous HPLC Assay: Advanced HPLC methodologies are utilized for the simultaneous, precise quantification of both Ivermectin and Albendazole, ensuring the concentrations are strictly within the 90.0% to 110.0% range of the labeled amount.
- Particle Size Analysis: We constantly monitor the micronization of the APIs to guarantee optimal dissolution parameters in the gut.
- Specific Gravity & Viscosity: Tested to guarantee the physical consistency and accurate pourability of the liquid.
- Microbial Limit Testing (MLT): Comprehensive screening confirms the absolute absence of pathogenic microorganisms, ensuring total safety for pediatric patients.
- Accelerated Stability Studies: Conducted in our dedicated stability chambers to validate the assigned shelf life across various extreme climatic zones.
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Safety Profile & Precautions
The combination of Ivermectin and Albendazole is generally well-tolerated when administered at recommended dosages. The most common adverse events are mild and transient, including mild gastrointestinal distress, nausea, dizziness, and headache. In mass drug administration (MDA) for filariasis, patients may experience a “Mazzotti reaction” (fever, rash, joint pain), which is an inflammatory response to the sudden death of massive numbers of microfilariae, not a direct toxicity of the drug itself.
However, strict professional discretion is required. The combination is contraindicated in pregnant women (particularly during the first trimester) due to the teratogenic potential of Albendazole observed in animal models. It must be used with caution in patients with pre-existing hepatic impairment, as both drugs are heavily metabolized by the liver, and Albendazole has been rarely associated with reversible elevations of liver transaminases. It is also contraindicated in patients with a known hypersensitivity to either benzimidazoles or macrocyclic lactones.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Ivermectin and Albendazole Oral Suspension, please use the B2B enquiry form below.
Pan-India Supply & Contract Manufacturing
Clinical Q&A for Ivermectin + Albendazole Suspension
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Ivermectin + Albendazole Suspension?
How do Ivermectin and Albendazole work together?
What is the standard dosing protocol?
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B2B Manufacturing Guide for Ivermectin + Albendazole Suspension
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.
