Formulation Development

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Formulation Development

At Topiox Research Centre Pvt Ltd, our expert Formulation and Development Team transforms promising drug candidates into stable, effective, and patient-centric pharmaceutical products. We specialize in the development of a wide range of dosage forms and drug delivery systems, offering end-to-end support from early formulation through to regulatory filing.

Our mission is to ensure that every active pharmaceutical ingredient (API) is delivered at the right dosage, at the right rate, and in the most efficient form to maximize therapeutic effect and patient benefit.

Formulation Development: From Concept to Clinic

Our Formulation and Development Laboratory is a cornerstone of our R&D operations. We focus on scientific innovation, regulatory compliance, and product scalability across a broad range of therapeutic areas and dosage forms. Whether it’s a new chemical entity (NCE) or a generic drug product, our formulation development approach is built to support all stages of the pharmaceutical lifecycle — from early discovery to commercial launch.

Why Choose Topiox Research?

      • Deep expertise in topical, ophthalmic, parenteral, and oral dosage forms
      • Integration of new drug delivery technologies
      • Strong track record in generic drug product development
      • End-to-end capabilities from R&D through regulatory support
      • Full confidentiality and regulatory compliance

1. Formulation Design and Optimization

We contribute to the development and optimization of pharmaceutical formulations for both novel products and reformulated versions of existing drugs. Our scientists evaluate and refine each formulation to meet specific goals such as solubility, stability, bioavailability, and patient compliance.

2. Collaboration with Analytical Development

Our Formulation Team works closely with the Analytical Development Laboratory to ensure that all formulations are analytically viable. We define specifications, establish test methods, and validate protocols as part of an integrated development process.

3. Experimental Planning and Analysis

We plan, conduct, and analyze experiments to fine-tune critical formulation parameters — such as excipient selection, process optimization, and drug release profile. This data-driven approach ensures reliable scale-up and manufacturing success.

Our Formulation & Development Capabilities

We provide specialized formulation development services for a wide array of dosage forms and delivery systems, including:

 Solid Oral Dosage Form Development

Robust and scalable formulations for tablets, capsules, powders, and granules — with an emphasis on manufacturability and bioavailability.

Liquid Dosage Form Development

Development of oral liquids, suspensions, and emulsions designed for stability, palatability, and ease of administration.

 Topical Formulation Development

Expertise in the development of topical creams, ointments, gels, and sprays, optimized for skin absorption and patient comfort.

 Parenteral Dosage Form Formulation

Sterile injectable products (IV, IM, SC) developed with attention to pH, osmolality, sterility, and shelf stability.

Nasal Spray and Ophthalmic Formulation Development

Safe and effective formulations for nasal sprays and ophthalmic products including eye drops, gels, and sterile emulsions.

New Drug Delivery Systems in Pharmaceutics

We develop novel drug delivery systems that improve therapeutic outcomes and extend patent lifecycles. Our technologies include:

  • Controlled-release and sustained-release formulations
  • Nanoparticles, liposomes, and micelle-based delivery
  • Mucoadhesive and targeted release systems
  • Solubility and absorption enhancement methods

Generic Drug Product & Formulation Development

We help clients develop high-quality generic formulations that meet regulatory standards for bioequivalence. Services include:

  • Reverse engineering and formulation design
  • Cost-effective optimization of excipients and processes
  • ANDA support and regulatory documentation

Lifecycle management and product improvements

Contract Formulation Development & CDMO Services

As a trusted Contract Development and Manufacturing Organization (CDMO), we provide:

  • Pre-formulation studies to assess API characteristics
  • Formulation development & optimization
  • Analytical method development and validation
  • ICH-compliant stability studies
  • Technology transfer and scale-up
  • Regulatory support including CMC documentation

We tailor our contract formulation services to the specific requirements of each client, ensuring flexibility, transparency, and timely delivery.