Natoli Products

11. Comprehensive Batch And Lot Testing Services 7/29/2024

    Batch and lot testing for release are critical steps in ensuring the quality and consistency of pharmaceutical tablets. Natoli Scientific provides comprehensive batch testing services that align with stringent industry standards and regulatory requirements. Each lot undergoes a rigorous analysis to verify that it meets predefined specifications for weight, tablet breaking force, thickness, diameter, and dissolution, among other critical quality attributes. The testing process is meticulously designed to screen for any variation that could impact the efficacy or safety of the final product.

    Utilizing state-of-the-art analytical equipment and methodologies, our experts ensure that each batch released by our clients is of the highest quality, providing end-users with the assurance that the medications they rely on are both safe and effective. This level of attention to detail fosters trust and reliability in pharmaceutical products processed through Natoli Scientific’s advanced batch and lot testing services.

12. Analytical Method Development And Validation 7/29/2024

    In pharmaceutical testing, the development and validation of analytical methods are absolute musts when it comes to reliable quality control. Natoli Scientific is at the forefront of offering comprehensive analytical method development and validation services designed to ensure the integrity of your company’s drug formulations. Our expert team develops robust methods tailored for each unique compound, with an approach that emphasizes precision, accuracy, sustainability, and compliance with regulatory standards such as the FDA and ICH guidelines. These methods are meticulously validated to confirm their reliability across a range of analytical parameters including specificity, sensitivity, linearity, and reproducibility.

    This validation process is critical for verifying that our methods produce consistent, trustworthy results throughout the product’s lifecycle, thus fostering confidence in the safety and efficacy of pharmaceutical products.

13. USP<1062> Tablet Compression Characterization 7/29/2024

    Natoli Scientific takes pride in its comprehensive USP<1062> Tablet Compression Characterization services, tailored to address the complexities of tableting in pharmaceutical manufacturing. Staying true to the parameters outlined in the United States Pharmacopeia (USP) Chapter 1062, our approach meticulously evaluates tablet compression behaviors. By thoroughly characterizing the compression profile, we can pinpoint the optimal compression force required to form a cohesive tablet without applying undue stress that could lead to capping — the separation of tablet tops during or after the compression phase.

14. Stability Testing – Onsite Preclinical Services To Support Your Product Development 7/29/2024

    Natoli Scientific’s preclinical stability studies represent a critical facet of our pharmaceutical testing services, providing essential data on the shelf life and storage conditions of drug candidates. These studies are expertly designed to evaluate physical, chemical, and microbiological stability, ensuring that formulations retain their safety, efficacy, and quality over time. Our state-of-the-art facilities simulate various environmental conditions to scrutinize the integrity of products under stress-testing scenarios. The results gleaned from our stability studies guide the development of robust drug formulations and packaging, aid in regulatory submissions, and lay the groundwork for successful commercialization.

15. Powder Flow Properties & Characterization Services 1/31/2024

    Basic Powder Flow Characterization [USP <1174>]:

    A powder flow analysis is an indicator of how well formulation will release from the hopper during the tableting. It is important to know that the developed formulation is showing ‘Mass Flow’ or ‘Funnel Flow’ or ‘Rat Holing’.

    Powder blend shows ‘Mass Flow’ when the entire solid bed is in motion during the discharge of material from the outlet. This is a ‘First-in-First-Out’ process. Hoppers offering ‘Mass Flow’ have steep and/or low-friction walls. This flow offers ‘No-Arching’, ‘Less Segregation’, and ‘Stable Powder Flow’.

    When the hopper is not sufficiently steep and smooth enough to ensure sliding along its wall, the powder blend exhibit ‘Funnel Flow’. Such hoppers are sensitive to arching and ratholing. In this case, powder discharge from the hopper is not predictable.

16. Oral Solid Dose Formulation Assessment Services 1/31/2024

    Send a test sample of your powder to Natoli Scientific to get your formula characterized following USP <1062> Guidelines (Tablet Characterization Methods) that we have been practicing for over 25 years.

17. Oral Solid Dose Formulation And Lab Scale Capabilities 1/31/2024

    Natoli Scientific is dedicated to developing high-quality affordable products for your market needs.

    We provide a formulation design based on a strong scientific understanding and 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.

18. OSD Pharmaceutical Tablet Manufacturing Services For Clinical Trials 1/31/2024

    Natoli Scientific offers manufacturing services of oral solids at a pilot scale and drug products for clinical trials.

    We also offer full-scale commercial manufacturing service till you are ready with your own manufacturing facility to avoid delay in the commercial launch.

    Team Natoli understands the complexity of the tablet manufacturing process over more than half a century. We are ready to shoulder every step of the tablet manufacturing chain from blending to granulation, to milling, to compression, to coating. Our manufacturing capabilities are backed up by our expert scientific team, who are ready to offer guidance in product development, technical transfers, and scale-ups.

19. Pharmaceutical Preformulation Support Services 1/31/2024

    Partner with Natoli Scientific during the earliest stages. Our scientific expertise with state-of-the-art analytical capabilities is ready to take any preformulation challenge.

    Natoli scientific has an expertise of handling a wide range of APIs for the development of oral solids. We apply principles of ‘Quality by Design’ to define Critical Material Attributes (CMA), Critical Process Parameters (CPP), Critical Quality Attributes (CQA) and Quality Target Product Profiles (QTPP). Because we believe that understanding material and process as much as possible in the early life cycle of drug product development program is an insurance for further development path. Keeping your practices up to date with the ICHQ8 regulatory guidance issued by the US FDA. This is also a gate way for a smooth ride of product in the different stages of product development stages.

20. Oral Solid Dose Formulation Troubleshooting Support Services 1/31/2024

    Natoli organization is a reputed leader with more than a half century experience in the tablet manufacturing technology.

    We understand tablets better. We are here for serving your needs to overcome challenges associated with commercial manufacturing of solid dosage forms across the globe (North America, Europe, Asia).

    Our Natoli scientific team uses holistic approach to understand and solve important tableting problems like capping, lamination, picking, and sticking. We integrate scientific information gathered at material, process, and instrument level to understanding and decode root causes of these common tableting issues.