Ibuprofen DC100 Archives - Ingredientpharm

Determination of Ribbon Solid Fraction in Roll Compaction using Ibuprofen DC100

Abstract

Process Analytical Technology (

P A T

) plays a crucial role in the design of today’s manufacturing lines as continuous manufacturing becomes more important. Until now

P A T

tools to measure the ribbon solid fraction (

S F_{r i b b o n})

in-line are not commonly used in roll compaction. The aim of this study was therefore to establish a new approach as

P A T

for in-line ribbon solid fraction determination. Different placebo formulations with different binders and one formulation containing active pharmaceutical ingredient were investigated using in-line laser triangulation measurement to detect the ribbon thickness after compaction. With this the ribbon elastic recovery was determined in-line (

E R_{i n - l i n e})

while the ribbons are attached to the roll surface. It was found that the ratio (

E R_{r a t i o})

between the total elastic recovery and

E R_{i n - l i n e}

is formulation specific and not influenced by any process parameters. This enables

E R_{r a t i o}

as prediction tool for

S F_{r i b b o n}

, if the solid fraction at gap (

S F_{g a p})

width is known.

S F_{g a p}

was determined with ribbon mass flow measurement or based on the Midoux model, a simplified Johanson model, gaining two prediction models for

S F_{r i b b o n}

. Both models showed good agreement of the predicted

S F_{r i b b o n}

and the measured one.

Materials

Microcrystalline cellulose (MCC, Vivapur® 102, JRS Pharma, Germany), fine powder hydroxypropyl cellulose (HPC, NISSO HPC SSL SFP, Nippon Soda, Japan) and polyvinylpyrrolidone K 25 (PVP, Kollidon® 25, BASF, Germany) were selected as binders; dibasic calcium phosphate anhydrous (DCPA, DI-CAFOS® A60, Chemische Fabrik Budenheim KG, Germany) as filler and ibuprofen (IBU, Ibuprofen DC 100, IPC Process-Center GmbH & Co. KG, Germany) as active pharmaceutical ingredient. […]

Ibuprofen DC100 in this context

In the context of this publication, Ibuprofen DC100 likely serves as a model drug to investigate the efficacy of direct compression techniques in tablet formulation. Its unique properties make it an ideal candidate for studies focused on optimizing tablet manufacturing processes, improving drug release profiles, and enhancing patient compliance through better dosage form design.

By utilizing Ibuprofen DC100, researchers can explore the benefits of direct compression, such as reduced production complexity and cost, while maintaining high-quality standards in tablet formulation. This aligns with the ongoing efforts in pharmaceutical sciences to develop more efficient and patient-friendly drug delivery systems.

Conclusion

This study established an in-line triangulation laser measurement as novel

P A T

for the prediction of

S F_{r i b b o n}

based on

E R

measurement.

E R_{i n - l i n e}

values showed time and thus measurement spot dependency. However, the laser position does not influence the result of the prediction models for

S F_{r i b b o n}

. The

E R_{i n - l i n e}

was approximately 5 % for all formulations using smooth rolls and a formulation dependent

E R_{r a t i o}

was found. […]

References

Source: https://doi.org/10.1016/j.xphs.2023.10.013

Martin Lück, Stefan Klinken, Peter Kleinebudde, Journal of Pharmaceutical Sciences 113(4) 2024, 1020-1028

ingredientpharm

CPhI 2024: Welcome ingredientpharm in Milan/Italy

We are thrilled to announce ingredientpharm’s participation as an exhibitor at the prestigious CPhI worldwide exhibition, taking place on October 08-10, 2024, in Milan/Italy, booth 7B66. As a leading name in the pharmaceutical ingredients industry, ingredientpharm is dedicated to advancing the quality and efficacy of pharmaceutical excipients and API granulation. This year, we are excited to showcase our latest innovations and high-quality offerings: pharmaceutical pellets and granulated Ibuprofen DC100.

Pharmaceutical Pellets: Made for better formulations

At ingredientpharm, we understand the critical importance of precision and consistency in pharmaceutical manufacturing. Our pharmaceutical pellets are meticulously engineered to meet the highest standards of quality, uniformity and applicability to state-of-the-art formulations. These pellets offer superior opportunities for modified release profiles, enhancing the effectiveness of medications and ensuring patient compliance. Our advanced pelletization technologies guarantees that every batch delivers consistent quality, performance, providing pharmaceutical manufacturers with the reliability they need to produce safe and effective medicines. You have the choice for inert MCC pellets (CELLETS®) or functional starter beads (TAP®).

Granulated Ibuprofen DC100: A revolution in pain management

Introducing our groundbreaking product, granulated Ibuprofen DC100, a direct compression grade of Ibuprofen designed to streamline the tablet manufacturing process. This innovative granulation eliminates the need for complex processing steps, significantly reducing production time and costs. Ibuprofen DC100 is made of 100% API and comes without any need of further excipients. Ibuprofen DC100 ensures excellent flowability, compressibility, and dissolution properties, making it an ideal choice for manufacturers seeking to optimize their formulations. With this product, ingredientpharm is setting new standards in the production of non-steroidal anti-inflammatory drugs (NSAIDs), providing a reliable solution for effective pain management.

Visit Us at CPhI 2024

We invite you to visit our booth at CPhI 2024 to learn more about our cutting-edge pharmaceutical pellets and granulated Ibuprofen DC100. Our experts will be on hand to discuss how these products can enhance your formulation, improve efficiency, and benefit patients. Join us in exploring the future of pharmaceutical ingredients and discover why ingredientpharm is a trusted partner in the industry.

We look forward to seeing you at CPhI 2024 in Italy!