Moisture Sensitive Ingredients
Roquette offers one of the broadest portfolios of functional excipients designed for prescription oral dosage forms, with many solutions providing low Aw and moisture-scavenging properties. These features help extend API stability and simplify formulation development.
Low Moisture Excipients for Moisture-Sensitive APIs
Moisture is one of the most common threats to the stability of active pharmaceutical ingredients (APIs). Hydrolysis reactions, triggered even by small amounts of free water, can degrade sensitive compounds such as acetals, imines, and esters. While total moisture content is often measured, water activity (Aw) provides a more accurate predictor of API stability.
Our excipients support a wide variety of dosage forms such as tablets, orally disintegrating tablets (ODTs), capsules, sachets, granules, and powder for oral suspension (PFOS) in multiple manufacturing processes, such as direct compression, roller compaction, and dry granulation. Manufactured in EXCiPACT-certified facilities with full global regulatory support, they combine plant-based origin, sustainability, and proven safety.
With decades of experience, robust quality systems, and a strong innovation pipeline, Roquette is a trusted partner for pharmaceutical companies worldwide, providing not only reliable excipients but also technical expertise to accelerate development.
Our Solutions
Pharmaceutical developers face complex challenges when working with moisture-sensitive APIs. Hydrolysis can rapidly degrade actives, residual water can destabilize dosage forms, and the infrastructure required to maintain ultra-low humidity can drive up costs. Roquette's addresses these issues with a portfolio of excipients engineered for low water activity (Aw) and, in some cases, moisture-scavenging performance, helping to improve formulation robustness while offering manufacturing flexibility.
Reducing moisture-induced API degradation
APIs such as acetals, imines, and esters are highly vulnerable to hydrolysis. PEARLITOL® mannitol and MICROCEL® microcrystalline cellulose provide inherently low Aw values, reducing the risk of water-driven degradation. These excipients help stabilize formulations without the need for excessive packaging barriers.
Stabilizing oral dosage forms against free moisture
Even trace amounts of free water can compromise the integrity of oral solid dosage forms. PEARLITOL® ProTec co-processed mannitol-starch combines very low Aw (≤ 0.10) with water-scavenging capability, while LYCATAB® CT-LM and C-LM low moisture partially pregelatinized starch maintain a low Aw profile that supports stable binding, filling, and disintegration. Together, they help enhance the long-term reliability of tablets, ODTs, and sachets.
Lowering cost and complexity of manufacturing
Specialized packaging and humidity-controlled facilities significantly increase production costs. By integrating excipients such as SweetPearl® maltitol and XYLISORB® xylitol, developers can maintain formulation stability under standard manufacturing conditions. This reduces reliance on costly external controls and streamlines the path to scale-up.
Versatility across dosage forms and processes
Roquette excipients are designed with versatility in mind. From direct compression with PEARLITOL® mannitol, to roller compaction with MICROCEL® microcrystalline cellulose, and dry granulation with moisture-scavenging starches, the portfolio supports diverse process technologies. The ability to apply a single excipient solution across multiple dosage forms, including tablets, ODTs, capsules, sachets, granules, and PFOS, ensures efficiency for developers and quality for patients.
Our Services and Expertise
Roquette supports pharmaceutical partners not only through its excipient portfolio but also with a full range of services and innovations that reinforce formulation stability for moisture-sensitive APIs.
Customer Technical Services (CTS)
Our formulation scientists collaborate with development teams to design prototypes and troubleshoot challenges specific to moisture-sensitive actives. CTS experts help select the right low Aw or moisture-scavenging excipient, such as PEARLITOL® ProTec co-processed mannitol-starch or MICROCEL® microcrystalline cellulose, for a given dosage form, and optimize processes like direct compression or dry granulation to ensure long-term stability.
Sustainability
Roquette’s plant-based excipients provide sustainable options without compromising performance. By enabling stable formulations through the excipient itself, developers can often reduce reliance on resource-intensive packaging or humidity-controlled manufacturing environments, helping lower the overall carbon footprint.
Regulatory expertise
All of Roquette’s low moisture excipients are manufactured in EXCiPACT-certified facilities, with global regulatory support to ensure compliance across EP, USP, and JP pharmacopeias. This helps simplify development pathways and de-risk submissions for formulations where moisture stability is critical.
Innovation pipeline
Roquette continues to invest in new excipient technologies that address evolving stability challenges. From co-processed excipients like PEARLITOL® ProTec to multifunctional starches, our innovation efforts are guided by the needs of moisture-sensitive APIs and patient-centric dosage forms.
Featured Excipients for Low Moisture Stability
Roquette’s portfolio of low water activity and water-scavenging excipients helps ensure stability and performance across moisture-sensitive formulations.