Isotretinoin Pellets

Product Overview

Isotretinoin Pellets are specialized oral pharmaceutical formulations containing isotretinoin, a retinoid derivative of Vitamin A. These pellets are typically designed for incorporation into capsule dosage forms, offering controlled or sustained drug delivery. They are widely used in the management of severe recalcitrant nodular acne and other dermatological conditions that do not respond to conventional therapies.

Product Name
Isotretinoin Pellets
Strengths Available
20% (customizable per your offering)
CAS No. / IUPAC Name
CAS: 4759-48-2; IUPAC: (2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid
Molecular Formula / Weight
C20H28O2 / ~300.44 g/mol
Identification
Validated HPLC (USP/BP/EP)
Release Type
Immediate Release (IR), Sustained Release (SR), or Modified Release (MR) depending on formulation requirement
Applications
Capsules; tablets (primarily for severe acne and dermatological conditions)
Storage Conditions
Keep the pellets in a tightly sealed, light-resistant, and airtight container. Protect from direct sunlight and high humidity.

Acetaminophen DC Granules – Typical Composition

Component	Function
Isotretinoin	Active Pharmaceutical Ingredient (API)
Sugar Spheres / MCC Spheres	Inert core or starter pellets
Hydroxypropyl Methylcellulose (HPMC)	Binder / Film former during layering
Talc / Colloidal Silicon Dioxide	Anti-adherent / Glidant
Eudragit RS/RL, Eudragit L100-55, or similar polymers	Release-controlling or enteric coating polymer (for SR/MR/DR formulations)
Triethyl Citrate / PEG 6000	Plasticizer (to improve coating flexibility)
Purified Water	Solvent (removed after processing)

Why Choose Pellets from Salius Pharma?

Outsourcing pellets through a trusted partner like Salius Pharma can be a strategic decision to save both time and resources, without compromising on quality or compliance. Instead, partnering with Salius Pharma—a leading distributor aligned with USFDA-approved and WHO-GMP-certified manufacturers in India—allows you to leverage high-quality products, seamless logistics, and professional support under one roof.

Key Advantages of Partnering with Salius Pharma

Cost-Efficient Setup
Avoid heavy capital investment in infrastructure and workforce.
Guaranteed Quality Assurance
Products are sourced only from certified facilities with validated processes.
Access to Advanced Technology
Benefit from the latest drug delivery systems without managing the tech in-house.
Accelerated Market Entry
Launch products faster and establish your brand in less time.
Custom Formulation Support
Flexibility to offer tailored pellet solutions as per your market needs.

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times may vary depending on destination, order volume, and regulatory requirements.

Place an Order or Request a Quote from Salius Pharma

Looking to source Isotretinoin Pellets or other high-quality pharmaceutical pellet formulations?
Whether you need Active Pharmaceutical Ingredients (APIs), excipients, or regulatory support, our team is ready to provide reliable, compliant, and cost-effective solutions tailored to your market needs.

Get in Touch

Email: export@saliuspharma.com
Call / WhatsApp: +91 84258 80640 / +91 84258 80643
Landline: +91 22 49700 601 / +91 22 44503 148
Corporate Office: 3104–3106, Plan S Business Park, Nerul MIDC Opp. Dr. D.Y. Patil Stadium, Navi Mumbai – 400706, Maharashtra, India

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Any patented products are excluded from our offerings in regions where such patents are currently in force.

FAQs

Isotretinoin Pellets are primarily used for the treatment of severe nodular acne that does not respond to standard therapies. They are also explored in certain keratinization disorders and dermatological conditions.

They are manufactured using multiarticulate pellet technology with inert starter cores, binders, polymers, and protective coatings to ensure controlled drug release and stability.

Quality is verified using validated HPLC methods (USP/BP/EP) for assay and related substances, along with stability studies under ICH guidelines.

Yes, by modifying polymer type, coating thickness, and layering technique, the release can be designed as IR, SR, or DR depending on therapeutic needs.

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