LipoGalen™ 144 – The innovative new base for ovules and suppositories

Novelty
- Crystallizes in one stable modification in contrast to triglycerides
- New base is a “hydrophilic lipid”, thus
- Hydrophilic character allows for stable water uptake which is unusual for lipid-based excipients
- Lipidic character leads to better adhesion to the mucous membrane, resulting in potentially longer contact time
Case Study: LipoGalen™ 144 – A new base for lactic acid ovules
A case study in structured development and usability validation of a gynecological medical device
Goal
- Development of a medical device with LipoGalen™ and lactic acid.
- It shall be comparable to a reference product.
Focus
- Formulation development with LipoGalen™ and lactic acid comparable to the commercial benchmark.
- Evaluation of the application in a usability study to demonstrate comparable user experience and identify additional benefits.

The Product
- IOI lactic acid ovules are a medical device designed to support and maintain a healthy vaginal microbiome
- Their innovative formulation enables a potentially longer contact time and thus a longer-lasting release of lactic acid
Advantages
- Natural. Effective. Long-lasting. Vegan.
- Next-generation vaginal ovules: Petroleum- and PEG-free, patented base*, slow melting behavior
- High demand (CAGR: 4.6%): Meets growing consumer preference for natural intimate care products
Product development strategy
Systematic evaluation identified a safe, stable, and user-friendly device
- Initial safety checks
- Absorption capacity
- Melting point
- “Hardness”
- „Dissolution“ behavior
- Stability testing
- Optimized formulation
- Robust stability
Green light for usability study with ovules made with LipoGalen™ 144
Head-to-head usability study compared the new device against the commercial benchmark
Usability study – Objective:
- Collect data to demonstrate the comparability of IOI Oleo lactic acid ovules with the reference product
Study methods:
- Structured questionnaires to be answered after the application of the ovules
Usability Study – Results
- Safety: no device-related issues
- Users reported that the new device felt pleasant and comfortable
- Comparable to reference product
- Additional benefit: new product may also be suitable for daytime use because of improved mucoadhesive properties
See the full brochure as PDF on LipoGalen™ 144 here:
(click the picture to download the brochure)

Source: IOI Oleo, poster LipoGalen™ 144, CPHI-2025_LipoGalen_ovules_WEB.pdf











































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