Qalitex Raises Concern Over Stability Data Gaps in Novel Dosage Formats

As the supplement and pharmaceutical industries race to innovate with novel dosage formats—including gummies, melts, chewables, and liquid sachets—Qalitex is raising concern over a critical issue: the lack of comprehensive stability data to support these emerging products. While these new formats are driving consumer appeal and market growth, many are being launched without the rigorous stability testing needed to guarantee safety, potency, and shelf-life consistency.

Unlike traditional tablets and capsules, novel formats often contain complex ingredient matrices, higher water activity, or unique excipients that make them more vulnerable to moisture, heat, light, and microbial growth. Without robust stability testing, brands risk releasing products that degrade prematurely, lose efficacy, or fail to meet regulatory requirements once distributed globally.

Qalitex highlights several key risks associated with incomplete stability data:

Inaccurate shelf-life claims that mislead consumers.

Formulation breakdowns that compromise taste, texture, or potency.

Regulatory non-compliance, leading to recalls or market restrictions.

Erosion of consumer trust when product quality is inconsistent.

To address these risks, Qalitex urges brands to:

Conduct both accelerated and real-time stability studies specific to each new dosage form.

Test products under realistic distribution and storage conditions, including variable humidity and temperature ranges.

Collaborate with accredited labs to ensure regulatory-ready documentation.

Consider packaging solutions that mitigate environmental stressors unique to novel formats.

“Novel dosage formats represent exciting progress in consumer health,” Qalitex notes, “but innovation without rigorous stability science is a liability. Closing these data gaps is essential to ensuring product safety, compliance, and long-term market success.”

With this advisory, Qalitex reaffirms its commitment to advancing scientific rigor in product development, ensuring that industry innovation is matched by the highest standards of stability testing and quality assurance.