Oral Solid Dose Formulation And Lab Scale Capabilities

The US FDA ICHQ8 has recommended QbD applications for the pharmaceutical development processes. QbD has been used to define Critical Material Attributes (CMA), Critical Process Parameters (CPP), Critical Quality Attributes (CQA), and Quality Target Product Profiles (QTPP). We believe that understanding material and process as much as possible in the early life cycle of a drug product development program is an insurance for further development path. Keep your practices up to date with the ICHQ8 regulatory guidance issued by the US FDA. This is also a gateway for a smooth ride of product in the different stages of product development stages.

We offer Design of Experiments (DoE) studies for smart experimentation to capture maximum information with minimum laboratory efforts. We do offer discrete studies if necessary. This keeps low study costs for our customers, as we believe that saving is earning.

We offer the following formulation support services

• Compaction simulation/emulation
• Excipient selection
  • Drug-excipient compatibility screening
  • Right excipient selection using QbD principles
  • API-Excipient quality control
• Formulation development services
  • Initial formulation design and screening to identify lead prototype formulation (composition and process)
  • Choose a suitable manufacturing process
  • Formulation and process parameter optimization using QbD principles
  • Scale-up of a prototype formulation
  • Scale-up of batches and technology transfer

Compaction Simulator/emulation

A successful compact of your formulation is the right marriage of material response to tablet manufacturing conditions. An early entry of compaction simulation in the formulation development can predict the manufacturability of the tablet product.

Simulating high-speed manufacturing conditions with Presseter will allow you to evaluate your formulation response to real production scenarios.

Natoli compaction simulation service could possibly eliminate scale-up surprises and smooth the transition from lab to scale-up to actual manufacturing.

Excipient Selection And Excipent Quality Control

Excipient Selection:

Combining material behavior with tablet manufacturing parameters using Design of Experiment (DoE) will provide a scientific approach for selecting the right excipients with an appropriate amount for developing a successful compact.

We will provide you with the right combination of excipients based on the inherent material deformation of your API by performing a compaction analysis.

Excipient Quality Control:

A dynamic compression profiling can distinguish material deformation of similar and different materials.

A dynamic compaction analysis is a powerful tool for quality control of API and Excipients.

We provide this testing for checking ‘batch-to-batch’ consistency of your raw materials.

This beforehand knowledge is an important tool to choose or replace raw materials vendors without compromising the product integrity specifically during SUPAC.

Batch-to-Batch Consistency Testing with RD10a Compaction Tester

Formulation Development

We believe in DRIFT (“Do It Right The First Time”). We practice this managerial accounting technique which centers around decreasing waste and increasing the efficiency of any process or work. Therefore, Natoli Scientific formulation scientist team provides a formulation design based on a strong scientific understanding. We believe in the decoding interplay of materials and process parameters to ensure product integrity. We use traditional as well as principles of ‘Quality by Design (QbD)’ to develop robust lead prototype formulations. The early sound scientific investment in product development saves time and money during scale-up and commercial manufacturing.

We practice all ethical and legal principles in our Research and Development activities to remain in compliance with the regulatory authorities. Our formulation scientist team is equipped with full-fledged ‘state-of-the-art’ equipment with the required scientific knowledge for serving your formulation development needs.

We offer the following formulation development services:

• Initial formulation design and screening to identify lead prototype formulation (composition and process)
• Choosing a suitable manufacturing process
• Formulation and process parameter optimization using QbD principles
• Scale-up of prototype formulation
• Scale-up of batches and technology transfer