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Dosage Formulations Development Services Dosage Formulations Development Services

Dosage Formulations Development Services

Expertise in formulation development of oral, parenteral and topical dosage forms, support clinical phase studies for IND/NDA and commercial supplies.

Starting with comprehensive preformulation services to commercial manufacturing, we provide a full suite of services for formulations of oral, parenteral, and topical dosage forms. We offer "Fit-for-purpose" formulation development for preclinical and First-in-Human (FIH) studies based on molecule's physicochemical behavior, excipient compatibility studies, and quick screening of excipients.

Our state-of-the-art formulation manufacturing facilities are in Hyderabad and Visakhapatnam and are audited by all major regulatory agencies.

Cross-functional teams such as DMPK, API synthesis, salt screening, toxicology, process engineering, analytical development, and regulatory teams are located in the same campus and work in an integrated manner at each stage of the life cycle of the molecule for efficient and on-time delivery.

Speak to our experts

Oral Dosage Forms

We offer integrated oral dosage form services right from preformulation services to commercial manufacturing. We provide recommendations for best dosage form to clinic, based on the preformulation study results and help customers to choose the phase appropriate dosage form that suites the therapeutic objective.

Preformulation services:

  • API physiochemical characterization
  • Molecule stability behavior
  • Solubility enhancement by various techniques

Based on API characteristics, we provide recommendations for maximizing the bioavailability of the molecule through solubility and permeability enhancement, gastro retentive formulation and targeted drug delivery systems.

We offer preclinical supplies of formulations for animal studies from R&D. Our state of art lab facilities are equipped with miniature lab equipment that enables fit for purpose formulation development using minimum batch size as low as 50 g blend using minimal drug substance quantities.

We also offer support to veterinary formulations for development of customized formulation.

"Phase appropriate" dosage form development services for early phase clinical trials (Phase 1&2):

Insights from the preformulation and preclinical studies are considered while designing dosage forms like tablets, capsules, oral liquids.

In addition to conventional approaches, we have expertise in:

  • Masking the taste of the bitter-tasting drugs, support to select the type and level of sweeteners, flavours, and complexation agents using 'e-tongue technology'.
  • Multi-unit particulate systems (MUPS) to achieve tailored drug release of actives in fixed dose combination to enable immediate and modified release of multiple active ingredients.

Late phase formulation development for Phase 3/Commercial supply:

We offer wide variety of dosage forms for late phase development up to commercial manufacturing. Our state-of-art laboratory equipment help to develop robust formulation using QbD approach and evaluate impact of formulation variables and critical material/process variables on drug product quality attributes during the lab scale development and provide recommendations for successful scale up and registration batches.

In addition to traditional dosage forms, we have the capability to develop and manufacture highly complex formulations involving bi-layer tablets, multi-particulate systems (Pellets or Mini-tablets in capsules), fixed dose combinations, very low and high-dose products, modified release formulations, oral solutions and suspensions. We provide patient-centric solutions for dosage form design.

We have access to state-of-art manufacturing facilities that are approved by US FDA, MHRA, and WHO to enable seamless cGMP manufacturing of clinical/registration and commercial batches. Most of the manufacturing facilities follow paperless electronic BMR systems and comply to stringent regulatory requirements.

Summary table:

Dosage form & CapabilitiesPreclinical formulation support for GLP tox studiesFormulation and Analytical DevelopmentcGMP Execution
Analytical Method DevelopmentComposition DevelopmentProcess DevelopmentAnalytical Method ValidationTech TransferClinical batches & SupplyCommercial batches
Oral Solids 
Tablets●●●●●●●●
Capsules●●●●●●●●
Multi-particulates●●●●●●●●
Granules in sachet●●●●●●●●
Oral Liquids 
Oral solution/drops●●●●●●●●
Oral suspension●●●●●●●●

● Indicates service available

Parenteral Dosage Forms

Our deep and broad expertise in parenteral dosage form development provides ample insight and innovation, making us a valuable partner in advancing your molecule. We offer expertise in overcoming challenges associated with parenteral drug product development such as but not limited to:

  • Solubility enhancement studies
  • Achieving a good compatibility of the drug substances with the excipients
  • Establishing the compatibility of the preparations with the container closure system
  • Stability challenges

A constant focus on key control measures from pre-formulation development through drug product development to GMP manufacturing is provided to meet time-to-market schedules within the prescribed budget. With a portfolio of options to choose from, we partner with customers to find the approach that best achieves their technical goals.

Parenteral dosage forms

Fig: Flow diagram for services offered in Parenteral dosage forms

Parenteral formulation development includes following activities but not limited to identification, selection and optimization of:

  • Formulation composition (solubility enhancers, isotonicity agents, chelating agents, bulking agents, anti-oxidants, preservatives, etc.)
  • Process and process parameters (mixing speed and mixing time, process temperature, order of addition of excipients, etc.)
  • Product Container closure system
  • Other supporting studies such as in-use stability studies, preservative effectiveness testing, compatibility and hold time studies and stability studies, reconstitution studies and dilution studies

Our parenteral formulation development lab is equipped with all essential instruments, including critical equipment such as:

  • Martin Christ 2-10D LSC plus pilot scale lyophilizer
  • Bead Mill
  • High pressure homogenizer
  • Fedegari counter pressure autoclave

Our state-of-art manufacturing facilities for parenteral dosage forms are located at Vishakapatnam and are approved by major regulatory agencies (MFDS/USFDA/MHRA).

Summary table:

Dosage form & CapabilitiesPreclinical formulation support for GLP tox studiesFormulation and Analytical DevelopmentcGMP Execution
Analytical Method DevelopmentComposition DevelopmentProcess DevelopmentAnalytical Method ValidationTech TransferClinical batches & SupplyCommercial batches
Injectable Dosage forms 
Liquid and Lyophilized●●●●●●●●
Suspension ●●●●●●●
Emulsions●●●●●●●●
Peptide Complex Injectables●●●●●●●●
Nano-Suspension Injectables●●●●●●●●
Microsphere Injectables●●●●●●●●
Ophthalmic and Otic Dosage Forms 
Ophthalmic Solutions●●●●●●●●
Otic Solutions●●●●●●●●
Nasal Dosage Forms 
Nasal Solutions/sprays●●●●●●●●
Blow fill seals for Nebulization●●●●●●●●

● Indicates service available

Topical Dosage Forms

We offer formulation development through a skilled scientific team with expertise in topical dosage forms both in conventional and microsphere-based formulations:

  • Ointments
  • Creams
  • Gels

We provide tailor-made solutions to address the challenges of topical dosage forms, helping optimize development time and cost.

Summary table:

Dosage form & CapabilitiesPreclinical formulation support for GLP tox studiesFormulation and Analytical DevelopmentcGMP Execution
Analytical Method DevelopmentComposition DevelopmentProcess DevelopmentAnalytical Method ValidationTech TransferClinical batches & SupplyCommercial batches
Topicals 
Ointment●●●●●●●●
Cream ●●●●●●●
Gel●●●●●●●●

● Indicates service available

Why choose Aurigene Dosage Formulations Development Services?

Fit-for-purpose development strategy

Integrated cross-functional teams such as PK-PD, API synthesis, salt screening, toxicology, process engineering, and analytical development teams

Services across the product lifecycle

USFDA inspected GMP facilities

Other Services

Virtual Tour

 

Connect with our scientific experts for your drug discovery, development, and manufacturing needs

We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.

Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.

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