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Sci. Pharm.
Volume 93
Issue 2
10.3390/scipharm93020024
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Application of Lactose Co-Processed Excipients as an Alternative for Bridging Pharmaceutical Unit Operations: Manufacturing an Omeprazole Tablet Prototype via Direct Compression

by
Raymar Andreina Lara Garcia
1,*,†,
Jesús Alberto Afonso Urich
1,2,*,†,
Andreina Isabel Afonso Urich
1,
Dalibor Jeremic
3 and
Johannes Khinast
1,2
1
Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria
2
Institute of Process and Particle Engineering, Graz University of Technology, Inffeldgasse 13, 8010 Graz, Austria
3
Department of Health Studies—Biomedical Science, FH JOANNEUM, Alte Poststrasse 149, 8020 Graz, Austria
*
Authors to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Sci. Pharm. 2025, 93(2), 24; https://doi.org/10.3390/scipharm93020024
Submission received: 26 February 2025 / Revised: 20 May 2025 / Accepted: 22 May 2025 / Published: 28 May 2025
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Abstract

Improving the manufacturability of drug formulations via direct compression has been of great interest for the pharmaceutical industry. Selecting excipients plays a vital role in obtaining a high-quality product without the wet granulation processing step. In particular, for diluents which are usually present in a larger amount in a formulation, choosing the correct one is of utmost importance in the production of tablets via any method. In this work, we assessed the possibility of manufacturing a small-molecule drug product, omeprazole, which has been historically manufactured via a multi-step processes such as wet granulation and multiple-unit pellet system (MUPS). For this purpose, four prototypes were developed using several diluents: a co-processed excipient (Microcelac®), two granulated forms of alpha-lactose monohydrate (Tablettose® 70 and Tabletose® 100), and a preparation of microcrystalline cellulose (Avicel® PH102) and lactose (DuraLac® H), both of which are common excipients without any enhancement. The tablets were produced using a single punch tablet press and thoroughly characterized physically and chemically in order to assess their functionality and adherence to drug product specifications. The direct compression process was used for the manufacturing of all proposed formulations, and the prototype formulated using Microcelac® showed the best results and performance during the compression process. In addition, it remained stable over twelve months under 25 °C/60% RH conditions.
Keywords: co-process excipient; direct compression; drug delivery system(s); formulation; oral drug delivery; solid dosage form(s) co-process excipient; direct compression; drug delivery system(s); formulation; oral drug delivery; solid dosage form(s)
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MDPI and ACS Style

Lara Garcia, R.A.; Afonso Urich, J.A.; Afonso Urich, A.I.; Jeremic, D.; Khinast, J. Application of Lactose Co-Processed Excipients as an Alternative for Bridging Pharmaceutical Unit Operations: Manufacturing an Omeprazole Tablet Prototype via Direct Compression. Sci. Pharm. 2025, 93, 24. https://doi.org/10.3390/scipharm93020024

AMA Style

Lara Garcia RA, Afonso Urich JA, Afonso Urich AI, Jeremic D, Khinast J. Application of Lactose Co-Processed Excipients as an Alternative for Bridging Pharmaceutical Unit Operations: Manufacturing an Omeprazole Tablet Prototype via Direct Compression. Scientia Pharmaceutica. 2025; 93(2):24. https://doi.org/10.3390/scipharm93020024

Chicago/Turabian Style

Lara Garcia, Raymar Andreina, Jesús Alberto Afonso Urich, Andreina Isabel Afonso Urich, Dalibor Jeremic, and Johannes Khinast. 2025. "Application of Lactose Co-Processed Excipients as an Alternative for Bridging Pharmaceutical Unit Operations: Manufacturing an Omeprazole Tablet Prototype via Direct Compression" Scientia Pharmaceutica 93, no. 2: 24. https://doi.org/10.3390/scipharm93020024

APA Style

Lara Garcia, R. A., Afonso Urich, J. A., Afonso Urich, A. I., Jeremic, D., & Khinast, J. (2025). Application of Lactose Co-Processed Excipients as an Alternative for Bridging Pharmaceutical Unit Operations: Manufacturing an Omeprazole Tablet Prototype via Direct Compression. Scientia Pharmaceutica, 93(2), 24. https://doi.org/10.3390/scipharm93020024

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