We offer formulation development through a highly skilled scientific team with expertise in variety of dosage forms. At our state-of-the-art facilities, we handle simple and complex oral solid dosage forms which include tablets, capsules, powder for suspension and multi-particulate drug delivery systems customized for immediate release, modified release and targeted release.
We provide ‘Fit-for-Purpose’ formulation development to support early phase/ ‘First-in-Human’ studies and also provide end-to-end services up to commercial manufacturing. We also support for development of customized formulations for veterinary use and nutraceutical applications.
Our expert team is having experience in developing complex formulations and provide tailored solutions to your problems and help to optimize the development time and costs.
Service Offerings:
Solid Oral Dosage Forms
We offer extensive end-to-end services of formulation development for a wide variety of oral dosage forms. Our team assists from Prototype formulation screening studies, Formulation/process optimization using QBD principles, ICH compliant Stability studies, Scale-up/technology transfer, formulation development to development of First-in-Human (FIH) formulations to enable clinical trial studies from phase I to phase III/ commercial manufacture. We are equipped with state-of-the-art facilities to manufacture 500 to 50,000 units at R&D and up to 7,500,000 units at commercial manufacturing sites and complete CMC support for regulatory submission.
Technologies Offered
- Direct tablet compression
- Fluid bed processing (granulation, drying, coating)
- High-shear wet granulation and drying
- Dry granulation (roller compaction, slugging)
- Extrusion-Spheronization
- High-speed automated tablet compression
- Perforated pan tablet coating (mini tablets coating)
- Automated capsule filling (powder, granules, pellets, mini tablets)
- Low humidity/moisture requirements
- Light-sensitive compound handling
Tablets
Immediate Release, Delayed Release, Sustained Release, Oral Disintegrating, Film coated, Taste masking, Fixed Dose Combinations (FDC).
a. Single Layer Tablets
Depending on the mode of usage conventional uncoated or film coated immediate release tablets, orally disintegrating tablets, sublingual tablets, buccal tablets, taste masked tablets, effervescent tablets and chewable tablets can be developed
b. Delayed release/ modified release tablets
Proven expertise in formulation of acid labile drugs using delayed release technology and where necessary the drug release can be modulated or targeted to release at specific regions of the gastro-intestinal tract.
c. Bilayer Tablets
A combination of immediate release (loading dose) and modified release portions of a single drug can be incorporated in a single dosage form. Also, a combination of two or more drugs which may be incompatible can be formulated based on the requirement
d. Mini Tablets Fixed dose combination (FDC) or standalone drug molecules can be formulated as minitablets whi>ch offer the advantage of being multi-unit particulate systems
(MUPS) like avoiding dose dumping, tailored drug release profile, targeted to release at specific regions of the gastro-intestinal tract etc.
Capsules
a. Hard Gelatin Capsules
Powders, pellets, mini tablets or their combination can be filled into hard gelatin capsules
b. Soft Gelatin Capsules
Soft gelatin capsules can be developed for liquids or suspension filling for poorly soluble and thermolabile, photosensitive medicaments.
Powders for Suspension
We develop age appropriate, easily reconstitutable powders for oral suspensions which can be filled into sachets
Why Aurigene Solid Orals Services?
Services across the product lifecycle
US FDA inspected lab and manufacturing facilities
Experience with advanced formulation technologies
20+ years of experience in formulation
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
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.
Resources
OCTOBER 01, 2024
PROTACs: Research for a life without cancer
PROTACs: Proteolysis-targeting chimeras (PROTACs) are a rapidly evolving field with promising applications in cancer, neurodegenerative diseases, and other conditions where the regulation of protein levels is crucial. PROTACs are a novel class of small molecules designed to target specific proteins for degradation by the ubiquitin-proteasome sys...
Read More
Advancement in personalized medicine and how the CRDMO industry is part of the solution
Personalized medicine is transforming the healthcare landscape by customizing treatment plans to individual patients’ unique genetic, clinical and environmental characteristics. These are effective and less invasive treatments for a wide range of conditions. Contract Research, Development and Manufacturing Organizations (CRDMOs) play an important role...
Read More
Cell Line Development
We enable development of stable and high yielding recombinant Mammalian and Microbial lines. ...
Read More
Case study: Tackling CYP 2C9 inhibition challenges
The Problem: Active compounds in a project were found to be highly potent inhibitors of CYP 2C9 The compounds selectively inhibited CYP 2C9 with IC50 values <100 nM There was no considerable inhibition of the other CYP isoforms Our Mitigation Approach: CYP 2C9 inhibition data was generated for a larger set of co...
Read More
Synthesis of Anti-covid Drug Nirmatrelvir Using Flow Chemistry
2022
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...
Read More-
Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2005
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...
Read More -
Wang-OSO3H catalyzed green synthesis of bioactive isoindolo[2,1- a ]quinazoline-5,11–dione derivatives: An unexpected observation
2005
The sulphonic acid-functionalized Wang resin (Wang-OSO3H) was explored as a polymeric and recov- erable acidic catalyst for the synthesis of isoindolo[2,1- a ]quinazoline-5,11–dione derivatives under green conditions. Thus the Wang-OSO3H ...
Read More -
Polycyclic Aromatic Compounds: A Simple and Efficient [(n-Bu3Sn)2MO4]n Catalyzed Synthesis of Quinazolinones and Dihydroquinazolinones
2005
A novel unprecedented approach for the synthesis of various quinazolinones and dihydroquinazolinones has been using [(n-Bu3Sn)2MO4]n as a catalyst. The reaction has been screened ...
Read More
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.
Leaving already?
Don't forget to join us at
CPHI Worldwide 2023.
October 24th-26th, 2023 | Barcelona, Spain
Get ready to accelerate your drug’s journey to the market