Formulation/Dosage Form
Seemax Biotech endeavour to create generic formulations is inspired by its philosophy of providing affordable healthcare to all sections of the society. We offer more than 500 high-quality affordable generic versions of expensive innovator medicines. Seemax Biotech commitment is paramount for bringing quality and innovation into its pharmaceutical products.
Seemax Biotech formulation and research is an amalgamation of a well-seasoned team of proficient and experienced scientists, technicians, and chemists who work relentlessly to solve tough challenges and provide innovative solutions for patients around the globe. To benefit patients and deliver the intellectual property to the organization, Seemax Biotech continually strives to discover the engineering solution of drug therapies in order to improve the safety and efficacy of its products.
Expanding further, Seemax Biotech is developing products for global markets.
Currently, Seemax Biotech is working on enhancing the bioavailability of molecules which may lead to a reduction in dose while increasing the safety profile of its drugs.
Formulations & Analytical Solutions
Seemax Biotech offers a range of Formulations & Analytical Services that include preformulation development, formulation development, analytical R&D, reformulation, stability studies, clinical supplies and manufacturing of exhibit batches*. We also offer standalone Analytical services for third party formulation products.
Our Regulatory team has a good understanding of the regulatory aspects of Formulations development. The team brings to the table their global experience and expertise for preparation and submission of ANDAs, INDs and NDAs.
Our objective is to provide a robust, production friendly formulation in shortest development time while incorporating best practices and adhering to stringent regulatory compliances. We focus on ensuring every stage of product development is successful. Our expertise lies in overcoming the challenges faced during studies of flowability, solubility, selection of drug-excipient combination, dissolution profiling, impurity profiling, bioavailability and bioequivalence.
Seemax Biotech deliver significant value to our clients of Formulations & Analytical Services by:
- Leveraging our scientific skill and global mindset
- Timely execution of projects
- Cost effective quality services
- Maintaining confidentiality and protection of intellectual property
- Consultative approach with thorough understanding of client needs
Preformulation Development
Seemax Biotech provides valuable expertise to guide the preclinical candidates to next steps with very small quantities of Active Pharmaceutical Ingredients (API) or candidate molecules. Our preformulation group has extensive experience in handling a wide range of NCEs and can suggest the path for successfully proceeding towards formulation development.
Seemax Biotech focus is on understanding and optimising the physical and chemical properties of API that enable the approaches for preclinical studies and subsequently for formulation development.
Seemax Biotech offers preformulation services in the following areas:
- Physical Properties: particle size, flow-ability, compressibility, bulk and tap density
- Intrinsic Dissolution
- Container Closure Interactions
- Drug/Excipient Compatibility
- Solubility (aqueous, non-aqueous, FaSSIF, FeSSIF and SGF mediums)
- pH-Solubility profile
- Impact of Particle Size on Dissolution
- Polymorphic Screening
- Solution State and Solid State Stability
- Hygroscopicity
Formulation Development Services
Formulation development studies determine the optimal dosage form, composition and manufacturing route is a fundamental part of pharmaceutical product development. Getting pharmaceutical formulation development right helps to optimise drug delivery performance and product stability. Complex dosage forms, in particular, inhaled and nasal products can present unique challenges for controlling the performance of the drug product and impact Bioavailability. At SEEMAX BIOTECH, we recognize the importance of our clients’ requirement to develop robust and compliant formulations. Our Formulation Development Services focus on both generic as well as NCE formulations, which fulfill regulatory requirements of targeted markets, possess attributes sought after by medical practitioners and meet customer’s performance metrics.
Seemax Biotech has the right equipment, facilities and highly dedicated formulation development specialists to help you arrive at the optimal dosage form for your API and application. We ensure any forms we develop are scalable, compliant and commercializable for our customers. We adopt a comprehensive, time-bound strategy in developing stable products that are efficient in all quality aspects. Our formulation development team enables small amounts of drug product materials to be developed using experimental design methodologies supported by testing at every stage with key performance analytics including solubility, dissolution, solid state characterisation and powder and particle morphology studies.
Formulation Development ServicesSeemax Biotech work on our formulation development strategy based on in-depth study of patents, scientific literature, compendia information, critical quality attributes (CQA) and quality target product profiles (QTPP) of the respective drug delivery system and nature of the molecule.
Seemax Biotech develop optimized processes that ensure smooth commercial manufacturing. We are sensitive in utilising the client investments/budgets to deliver a cost-effective solution for their formulation development needs. We help pharmaceutical companies to successfully resolve their challenging pharmaceutical compounds both in early-phase formulation development and as well as full generic development.
Formulation Development Services
Seemax Biotech development centre enables us to carry out formulation development services in a wide variety of dosage forms. We offer formulation development services with following dosage forms:- • Immediate Release
- • Delayed Release
- • Sustained Release
- • Orally Disintegrating
- • Bi-layered
- • Chewable
- • Parenteral Lyophilised powders
- • Taste masked orodispersible/dispersible powder
- • Effervescent granules
- • Reconstitutable powders & granules (for sachets and bottles)
- • Powder/granules
- • Pellets (IR, ER and SR)
- • FIH formulations – drug in capsule, powder blend/granules in capsules
- • Modified release – beads or mini tablets in capsules
- • Gels
- • Creams
- • Ointments
- • Solutions
- • Suspensions
- • Emulsions
- • Solutions
- • Ointments
- • Suspensions
- • Gels