Drug carriers à la carte from IOI – Precise individuality with WITEPSOL®
13. February 2022
According to a conservative estimate, approximately 1,000,000,000 (1 billion) individual patient doses are manufactured annually with our WITEPSOL® products for the application area of pain and fever management. This not only makes us proud, but also underlines our position as a global benchmark.
Contrary to the industrial trend towards streamlining and consolidating product portfolios, the Pharma business unit of IOI Oleo GmbH is sticking to the seventeen different active ingredient carriers within the four WITEPSOL® product families.
The individual products differ primarily in their chemical composition, melting points and behaviour, hydroxyl values and different additives used. Among others, anaesthetics, antidepressants, antiepileptics, vitamins, β-lactams, expectorants, hormones, steroids, laxatives, antifungals and opioids are being administered with this finely tuned toolbox of WITEPSOL® products.
In order to meet as many functional and regulatory customer needs as possible, we maintain this comprehensive spectrum of 17 finely accentuated excipients.
Melting Point:
As part of the selection of raw materials for a development project, the interaction of the ingredients in a formulation is examined and any changes in the melting point are considered. The melting point of a formulated API / carrier system largely determines the release profile. (More about release profiles in this post: Promising trends from the US market).
Hydroxyl Value:
The hydroxyl value determines the suitability for releasing specific APIs. It describes the ability of the drug carrier to stabilize the distribution of hydrophilic and / or suspended or dispersed ingredients in the matrix and to facilitate the absorption of less easily absorbable drugs.
Additives:
The addition of certain additives has shown that both the dispersibility of active ingredients and the wetting of mucous membranes, and thus absorption, are promoted.
Based on the shared properties, our WITEPSOL® is grouped into four product families:
The high degree of esterification and triglyceride content give this family precise and very discrete melting characteristics.
C
Compounds for suspension suppositories having a proportion of solid active compounds of over 25 %
melting point 31-33°C | HV = max. 3 | |
| WITEPSOL® H12 | melting point 32-33,5°C | HV = 5-15 |
| melting point 33,5-35, 5°C | HV = 20-30 |
C
Compounds for suspension suppositories having a proportion of solid active compounds of less than 25%
melting point 33,5-35,5°C | HV = max. 3 | |
| WITEPSOL® H5 | melting point 34-36°C | HV = max. 5 |
| melting point 33,5-35, 5°C | HV = 5-15 |
C
Compounds for suspension suppositories and lipophilic active compounds; for melting point correction
melting point 36-38°C | HV = max. 3 |
Optimized compositions with increased hydroxyl numbers give these products increased elasticity and surface activity. This improves the ability to solubilize active ingredients and stabilize the distribution of dispersed raw materials.
melting point 32-33,5°C | HV = 40-50 | |
| WITEPSOL® W 25 | melting point 33,5-35,5°C | HV = 20-30 |
| melting point 33,5-35,5°C | HV = 40-50 | |
| melting point 33,5-35,5°C | HV = 40-50 |
These products contain additives that improve the wetting properties on tissue and the dispersibility of hydrophilic compounds, including aqueous or ethanolic extracts.
melting point 30-32°C | HV = 55-70 | |
| WITEPSOL® S 55 | melting point 33,5-35,5°C | HV = 50-65 |
| melting point 31,5-33,5°C | HV = 60-70 |
Melting temperatures above normal body temperature make them the first choice as an additive for systems with lipophilic active ingredients that undesirably lower the melting point of a primary active ingredient carrier.
melting point approx. 38°C | HV = max. 15 | |
| WITEPSOL® E 76 | melting point 37-39°C | HV = 30-40 |
| melting point 42-44°C | HV = 5-15 |
In addition to the individual properties of the WITEPSOL® families, the products overall are characterized by the following properties:
Outstanding chemical and physical stability for a long shelf life of the finished dosage forms
- Compatibility with most APIs
- Excellent physiological compatibility
- Up to 100% raw materials of plant origin, optionally RSPO-MB certified
- GMP-certified manufacturing process (Read everything about the GMP manufacturing process here)
- Established by market leaders, with pronounced official acceptance, incl. TYPE IV DMF (Drug Master File)
Well-founded advice regarding application technology
More than a billion patient doses produced with our seventeen WITEPSOL® products underline the commitment of our customers and the commitment of IOI Oleo GmbH to patient health worldwide. At the same time, this figure makes it clear that we have the right solution for a wide variety of applications. Contact us and our local IOI Oleo GmbH representatives to find out what WITEPSOL® can do for your patients.
Robert Radsziwill
Robert Radsziwill joined IOI Oleo GmbH in 2019 as Sales Manager Europe in the Pharma division. Prior to joining IOI Oleo Pharma, Robert held technical and commercial roles in sales and product management for nine years at a supplier of raw materials to the Pharmaceutical and Medical Device industry. Through his experience with materials for pharmaceutical use and medical devices, Robert has contributed to the successful initiation and completion of new product development projects with industrial and academic partners in the Healthcare sector. Understanding, ranking and navigating technical, functional and regulatory concerns are paramount for him during early project ideation and material selection to ensure success for all project participants. Robert earned his diploma degree in Business Chemistry at the Westfälische-Wilhelms-University of Münster and has focused ever since on those disciplinary interfaces where technical and commercial minds join forces to innovate and improve the status quo.
