• search
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 pre-formulation 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 pre-clinical and First in Human (FIH) studies based on molecule’s physico-chemical 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

Service Offerings:

Oral Dosage Forms

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

Pre-formulation 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 pre-clinical 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 pre-formulation and preclinical studies would be taken into consideration 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 sweetener, flavours, complexation agents using ‘e-tongue technology’.
  • Xcelodose technology to directly fill the API in capsule with an accuracy of about 100 microgram to bring your NCE molecule right from preclinical stage to clinical stage in a cost effective manner.
  • 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 the 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

Parenteral Dosage Forms

Our depth and breadth of experience and specialization in parenteral dosage form development is remarkable which can provide insight and innovation. We offer the expertise in overcoming the 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 includes all the required equipments and also 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

Topical Dosage Forms

We offer formulation development through a skilled scientific team with expertise in Topical dosage forms both in conventional and microspheres based formulations

  • Ointments
  • Creams
  • Gels

We provide tailor made solutions to address the challenges of topical dosage forms and help to optimize the development time and costs

Summary table

Why Aurigene Pharmaceutical 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

Virtual Tour

The importance of business continuity planning in CRDMO industry

NOVEMBER 16, 2023

The importance of business continuity planning in CRDMO industry

Both natural and unnatural catastrophic events inflict negative consequences due to the ever-increasing interconnectedness of the global economy. Those consequences are certain to last for longer duration. e.g.; The Covid-19 pandemic is still having a negative impact on the global economy. Maintaining continuity is critical for all businesses, but perhaps no othe...

Read More

Accelerating Drug Discovery Through Innovative Partnerships

Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....

Read More

Physiochemical Characterization Services

Backed by our strong chemistry, we enable “Finger-print” protein structure and functional characterization for proteins from naked proteins to hyperglycosylated or derivatized proteins. ...

Read More

Gastro Retentive Dosage Form

Introduction: An orally-available anti-diabetic candidate that simultaneously targets all three key organs of diabetes: Pancreas, Liver and Muscles. This drug targets the two main defects seen in patients with type 2 diabetes: The pancreas by increasing insulin secretion, in a glucose-dependent manner; and the muscles and liver by decreasing the excess production...

Read More

An efficient and convenient protocol for the synthesis of tetracyclic isoindolo[1,2-a]quinazoline derivatives


A convenient and one-pot synthesis of tetracyclic isoindolo [1,2-a]quinazoline derivatives via Lewis acid mediated sequential C–N bond formation reactions is reported. This protocol provides a simple and rapid strategy for the synthesis of 12-benzylidene-10,12-dihydroisoindolo[1,2-b]quinazoline derivatives. However, a variety of tetracyclo indole fused quinazol...

Read More
View All

You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.

If you wish to continue to this external website, click Proceed.