We have a well-established formulation development lab to carry out formulation development activities of Oral solid and Parenteral dosage forms in our state-of-the-art R and D facility located in Hyderabad. This R and D center is dedicated to custom development projects. We are capable to handle small quantity batch size as low as 50g blend. This enables to reduce the API requirement for formulation development significantly.
Our R and D facility was audited by the US FDA in September 2017 and is also ISMS certified. All activities around formulation development including process optimization are carried out in this facility.
Our parenteral formulation development lab includes equipment such as Martin Christ 2-10D LSC plus pilot scale lyophilizer with a 10 liters condenser capacity, Fedegari counter pressure autoclave with 90 liters capacity and Memmert hot air oven. We are also equipped with IKA Ultraturrax’s T25 high shear mixer, Masterflex dosing pump and Laminar air flow system. The facility includes jacketed manufacturing vessels with one, two and five liters capacity, head space oxygen analyser, freezing point depression osmometer, conductivity meter, pH meter and Dissolved Oxygen meter. Validated stability chambers for conducting accelerated and prototype stability tests that support the selection of a lead and back-up formulation.
We have state-of-the-art US FDA and EU-approved pilot and production manufacturing facilities for scale-up where we offer clinical and commercial batches. The capacity varies from 15 - 1000 kg in the case of solid orals. The offerings include tablets, capsules and powder in sachets and soft gelatin capsules.
Resources
Continuous Flow Chemistry: A Game-Changer for Pharmaceutical Production
Fig 1:Schematic diagram of continuous flowFlow chemistry, also known as continuous flow chemistry, involves the continuous movement of reactants through a reactor to produce products. Unlike traditional batch chemistry, where reactants are mixed in a single vessel and processed in discrete batches, flow chemistry uses a continuous stream of reactants and intermed...
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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 in enabli...
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Anti-Infective Drug Discovery
Objective & Challenges: Objective was to identify an optimized anti-bacterial lead molecule with in vivo efficacy in relevant infection models an acceptable safety profile, and a patentable series. Challenge was to develop a more efficacious compound than the reference standard.Study design: Compounds were designed and synth...
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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets
2024
Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...
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A sensitive and a simple RP-HPLC method development and verification for the quantitative estimation of Cholecalciferol in tablets
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis [1]. It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization [2]. IUPAC name of Cholecalciferol is (3β, 5Z, 7E) 9,10-secocholesta-5,7,10(19)-trien-3-ol, whose molecular weight is 384.64 g/mol and its molecular formula...
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A simple RP-HPLC method development and verification for the quantitative estimation of Sodium Butyrate in tablets
Sodium butyrate is the sodium salt of butyric acid (Fig. 1), which exhibits various properties such as immune system modulator, antioxidant, and anti-inflammatory properties [1]. Furthermore, sodium butyrate is used as a promoter of growth in milk replacer formula for young calves [2]....
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Formulation Development and Characterization of ION and PH Dual Activated Nasal IN-SITU Gel Containing Levodopa and Carbidopa for the treatment of Parkinson’s Disease
Parkinson's disease is a chronic neurodegenerative disorder of the brain that results in involuntary or uncontrolled movements, including tremors, rigidity, and impaired balance and coordination. This condition is characterized by the depletion of melanin-containing neurons that are responsible for pigmentation in the midbrain....
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