Galvita
Welcome to a new class of drug delivery systems for ODTs
Galvita’s revolutionary, patented, and repeatedly clinically tested technology enables the production of micro capsules (Templated Inverted Particles / TIP) that can be loaded with many different active ingredients and easily compressed to tablets with excellent mechanical strength.
The unique properties of TIP-based tablets offer many benefits over other oral dosage forms, such as ultra-rapid disintegration (5-10 sec), fast onset of action (no first-pass effect), water-free ingestion (no swallowing), smaller tablet sizes, taste masking and a natural product composition (100% pure hydroxyapatite, no additives, ecological in production and degradation).
TIP-based Orally Disintegrating Tablets (ODT) enable the bypassing of hepatic clearance allowing for dose reduction and potential substitution of injections.
Galvita is has a highly experienced team, an own clinical development pipeline (currently 4 products) and access to infrastructure (for pharmaceutical development, GMP-manufacturing, clinical applications / trials) .
Our Technology (TIP)
Galvita-TIP microcapsules are a novel oral dosage technology and an innovative Drug Delivery Platform that has been successfully tested with over 25 APIs and is already in clinical use. It can be used across a wide range of therapeutic areas and is an ideal platform for treating acute conditions such as migraine, pain, nausea and other indications where rapid dosing and absorption is required.
The TIP technology offers an immediate onset of action and is a patient-friendly drug delivery strategy with specific benefits for patients who struggle to swallow conventional tablets such as geriatrics, pediatrics, or those that suffer from dysphagia.
Due to the unique properties of Galvita-TIP, the drug development may be significantly accelerated, and the manufacturing process is simple, scalable, and continuous, making it an affordable yet unique and universal drug delivery platform suitable for a wide range of indications.
Challenges in drug development:
- Technical risks: unsuitable formulations -> low patient acceptance
- Time: formulation development of 6-12+ months is on the critical path for new drugs (launch delay by one month can have a sales impact of CHF 100 million*
- Cost: cost of goods can become a success factor (high cost of manufacturing for other sophisticated formulations
Technical and business challenges can be overcome with our pharmaceutical technology
TIP Clinical advantages:
- Ultra-rapid bioavailability due to a two-step disintegration mechanism
- High drug load possible (up to 60%): allows for small tablets at usual dosages of active pharmaceutical ingredient (API) or high dosages without excessive tablet size
- Water-free application (i.e. no water needed to swallow tablet)
- Flexibility to tailor formulation characteristics to needs (distintegration speed, taste masking, etc.)
- Broad applicability: usable for broad range of APIs and molecular weights, incl. APIs with low solubility
- Low-cost manufacturing: no special equipment, standard materials
- Natural anorganic material. Biodegradable. Biocompatible.
- Targeted API release (oral cavity, pharynx, stomach)
- Targeted API release (oral cavity, pharynx, stomach)
- Hardness of tablet: easy to manufacture and apply, “perfect appearance”
TIP Clinical Benefits – Appealing Formulations for Problem Patients
Our Mission
“Imagine…
One tablet that disintegrates immediately on your tongue.
With fast action. No bad taste, no water needed, no more intramuscular injections. Just like … Micro Magic!“
We enable the development of patient-friendly drugs that are easy and safe to use, age-appropriate, and highly accepted to ensure patient compliance, which may lead to improved therapy outcomes.
We help Pharma innovators differentiate their products directly from launch, while also providing an opportunity to easily reformulate existing products as part of the portfolio lifecycle management strategy.
Needs of pediatric, elderly and other problem patients:
- Low drug adherence to swallow tablets / capsules: size, taste, etc.
- Low bioavailability of the active substance (API) and insufficient speed of dissolution (rapid onset of action is key)
> Patient-friendly medicines improves compliance, quality of life, therapeutic outcome and cost effectiveness
Research and Development
Galvita’s cutting-edge technology is managed by a versatile and experienced team that offers all key services throughout the entire value chain alongside the TIP technology.
Whether it involves early formulation and feasibility studies for clients interested in exploring a specific API or drug product specification at Galvita’s labs in Basel/Switzerland, conducting bioequivalence or efficacy studies of TIP-based products in a clinical setting compared to current practices, scale-up of production for TIP-based products, or providing support for IP or regulatory needs, Galvita and its selected network of industry-leading partners are available to realize development endeavors and ensure client success.
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