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Formulation

Formulation Development

In the realm of formulation development, Teadus Pharma Private Limited stands at the forefront of innovation and excellence. Our experienced team of formulation scientists and experts are committed to delivering exceptional services that cater to various needs, including the development of generic formulations as per Quality by Design (QBD) principles and 505(b)(2) applications.

We offer Prototype Formulation Screening Services, where we meticulously analyze and assess different formulation prototypes to determine the most promising candidates for further development. Through a comprehensive evaluation process, we identify formulations that exhibit optimal stability, bioavailability, and efficacy, setting the stage for successful product development.

Formulation Optimization Studies form a crucial phase in our development process. We employ advanced techniques and methodologies to refine and enhance the selected formulation, focusing on critical parameters such as solubility, drug release profiles, and compatibility. Our aim is to achieve an optimized formulation that ensures optimal therapeutic outcomes and patient compliance.

Additionally, our expertise extends to Process Optimization Studies, where we meticulously analyze and refine the manufacturing process to maximize efficiency, reproducibility, and scalability. By applying innovative approaches and utilizing state-of-the-art equipment, we strive to streamline the manufacturing process, resulting in cost-effective production and consistent product quality.

At Teadus Pharma, we recognize the significance of seamless technology transfer and scale-up activities. We possess the capabilities and experience to seamlessly transition formulations from lab-scale to commercial-scale production. Our dedicated team ensures a smooth and efficient transfer of knowledge, processes, and equipment to guarantee a successful and timely launch of your products.

With a steadfast commitment to excellence, innovation, and customer satisfaction, Teadus Pharma Private Limited is your ideal partner in formulation development. Trust us to deliver tailored solutions that meet regulatory requirements, exceed industry standards, and pave the way for the successful commercialization of your pharmaceutical products.

Pre-Formulation Services:

At Teadus Pharma Private Limited, we offer comprehensive pre-formulation services that lay the foundation for successful formulation development. Our team of skilled scientists and researchers specializes in a wide range of pre-formulation activities, ensuring a thorough understanding of the active pharmaceutical ingredient (API) and its characteristics.

API Characterization is a critical step in the pre-formulation process. We employ advanced analytical techniques to identify and characterize the physical and chemical properties of the API. This includes evaluating parameters such as particle size, melting point, polymorphism, and crystallinity, providing valuable insights for subsequent formulation development.

Forced degradation studies are conducted to assess the stability of the API under various stress conditions, including heat, light, and pH. By subjecting the API to accelerated degradation, we gain insights into its susceptibility to degradation pathways, enabling us to design robust and stable formulations.

Solubility profiling is essential to understand the API’s solubility behavior in different aqueous and non-aqueous solvents. Our state-of-the-art facilities allow us to perform solubility assessments, enabling us to determine the ideal solvents and formulation strategies for enhancing the bioavailability and dissolution of the API.

Compatibility testing of APIs and excipients is conducted to assess the compatibility and potential interactions between the API and various excipients. This evaluation ensures the selection of suitable excipients that maintain API stability and prevent any undesirable chemical or physical interactions.

We conduct comprehensive stability studies to evaluate the solid-state and solution-state stability of the API. By subjecting the API to various storage conditions, including temperature and humidity, we can determine its stability profile and potential degradation pathways, aiding in the selection of appropriate formulation approaches.

Hygroscopicity assessment is crucial to determine the moisture sorption characteristics of the API, as it can impact the stability and performance of the final formulation. Our experts employ state-of-the-art equipment and methodologies to evaluate the hygroscopic behavior of the API, ensuring proper formulation design.

Morphology assessment allows us to analyze the physical structure and morphology of the API. Through techniques such as microscopy and imaging, we gain insights into particle shape, size, and surface characteristics, enabling us to optimize formulation development and enhance product performance.

By leveraging our expertise in pre-formulation services, we equip our clients with comprehensive knowledge about the API’s characteristics, stability, and compatibility. This foundation serves as a critical step towards formulating safe, stable, and efficacious pharmaceutical products. Trust Teadus Pharma for reliable pre-formulation services that drive successful formulation development.

Formulation Infrastructure:

At Teadus Pharma, we possess a cutting-edge formulation infrastructure equipped with state-of-the-art equipment and facilities to support our formulation development processes. Our advanced infrastructure enables us to meet the diverse needs of our clients and ensure the highest quality standards in every aspect of our operations.

Here are some of the key components of our formulation infrastructure:

  • Rapid Dryer: Our rapid dryer is a high-performance drying system that facilitates efficient and quick drying of wet granulations or solutions, ensuring optimal product stability and uniformity.
  • Compression Machine – 8 Station: Our compression machine is equipped with eight stations, enabling us to efficiently produce tablets with precise weight, hardness, and uniformity. This advanced equipment allows for high-speed compression while maintaining strict quality control measures.
  • Manual Capsule Filling Machine: We have a manual capsule filling machine that enables accurate and efficient filling of capsules with various formulations. This machine ensures precise dosing and uniformity, meeting the specific requirements of different dosage forms.
  • Autoclave with Various Temperature Sequencing: Our autoclave is equipped with temperature sequencing capabilities, allowing for the precise control and sterilization of equipment, components, and formulations. This ensures the elimination of contaminants and the maintenance of aseptic conditions during manufacturing processes.
  • Lyophilizer: We have a lyophilizer, also known as a freeze dryer, which is a vital tool for the formulation and manufacturing of lyophilized products. This equipment allows for controlled freezing and sublimation of water from products, preserving their stability and extending their shelf life.
  • Mechanical Stirrers and Magnetic Stirrer: Our formulation infrastructure includes mechanical stirrers and magnetic stirrers to facilitate efficient mixing and blending of ingredients during formulation development. These devices ensure homogeneity and uniformity of the formulations, enabling accurate dosing and consistent product quality.
  • Gas Purging Unit: We have a gas purging unit that enables the removal of oxygen or other gases from formulations, packaging, or manufacturing vessels. This ensures the integrity and stability of the products, especially in sensitive formulations.
  • In-process Equipment: Our formulation infrastructure is equipped with various in-process equipment to support different stages of formulation development and manufacturing. These include equipment for granulation, blending, coating, and other critical processes, ensuring seamless and efficient production.
  • Circulating Water Bath: We utilize a circulating water bath to provide precise temperature control during various formulation processes, such as dissolution testing, stability studies, and other temperature-sensitive operations. This ensures accurate and reproducible results.

At Teadus Pharma, we continuously invest in our formulation infrastructure to stay at the forefront of technological advancements. Our state-of-the-art equipment and facilities empower our team to develop and manufacture high-quality pharmaceutical formulations with precision, efficiency, and adherence to regulatory standards.

At Teadus Pharma, our goal is to provide our clients with exceptional technical expertise, grounded in our specialist chemistry knowledge and robust project management capabilities. We are committed to delivering excellence, guided by internationally recognized ethical and quality standards.

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