Clinical ⁴

Renowned Performance

For several decades, Coni-Snap hard gelatin capsules (HGCs) have been the product of choice for pharmaceuticals and health care companies due to their reliable, outstanding performance worldwide.
Product Features & Options

Coni-Snap capsules are the most widely used capsule in the world for many reasons. Key capsule features and benefits include:

- Tapered rim of the body engages easily with the cap allowing for problem-free closure
- A dual snap-ring locking system provides full circumference leak-free containment
- Air vents allow air to escape during filling on high-speed capsule filling machines
- Rounded hemispherical ends are stronger and more resistant to deformation
- Available in a wide array of sizes
- Customizable with color and printing
- Suitable for a wide range of formulations for both pharmaceuticals and health and nutrition products
- Outstanding quality – manufactured in accordance with cGMP guidelines
- Certified quality assurance system for traceability of raw materials

New Plantcaps capsules help protect ingredients and healthy lifestyles.

Plantcaps capsules from Capsugel are the new premium capsules designed for the needs of the growing and very discerning healthy lifestyle market.

In the U.S., 35 percent of supplement users say vegetarian source is important when choosing a supplement—up from 26 percent in 2006. This group is among the most frequent users of supplements.
In a study of European supplement users, more than 45 percent said they would be more likely to purchase a supplement if they knew it was in a vegetarian capsule.

Plantcaps capsules provide the premier balance of performance and purity for healthy lifestyle consumers who are looking for naturally healthy attributes in the products they buy. Made from tapioca which is naturally fermented into pullulan, a starch-free vegetarian capsule, Plantcaps capsules speak to the needs of the most discerning consumers.
Everything your green consumers want in a capsule. Nothing they don’t.

- All the benefits of gelatin in a vegetarian capsule
- Organic label language allowed in the U.S. when filled with organic ingredients.
- The more natural alternative, starch-free, gluten-free, preservative-free, vegetable origin and non-GMO; Gras status, Halal and Kosher certifications
- New patent-pending formulation provides robust performance with a wide range of ingredients
- The best oxygen barrier properties
- Suitable for Asian regulatory environments

Ideal for Challenging Compounds

Vcaps® and Vcaps® Plus capsules can help solve formulation challenges and enjoy widespread acceptance for pharmaceutical and nutritional product registrations. Some key benefits include:

- Low-moisture content suitable for moisture-sensitive ingredients
- Negligible risk of cross-linking
- Elastic polymer structure enables robust commercial performance and high machinability

And Vcaps Plus capsules also offer:

- Contain just two components: vegetarian HPMC and water
- No gelling agents or additional excipients
- Reproducible, pH-independent dissolution for consistent delivery of active ingredients
- Physically stable polymer resistant to stringent heat and humidity conditions

Other Clear Benefits:

In addition to chemically stable formulation, Capsugel’s Vcaps and Vcaps Plus capsules
come with added value factors:

- Global supply capability eases scale-up to commercial production
- Kosher and Halal certified, Vegetarian Society approved
- Reduced regulatory filing
- Fully compatible with Capsugel’s Xcelodose® S precision powder micro-dosing system
- Outstanding quality – manufactured in accordance with cGMP guidelines
- Certified quality assurance system for traceability of raw materials

Developed For Phase IV Clinical Trials

MOD or MObile Data ePRO platforms are specifically developed for Phase IV clinical trials. Fully automated, real-time workflow from patient enrolment and e-PRO delivery right through to the data analysis and datasheet production, provides trial efficiency and scalability. MOD-MS employs an inbuilt library of e-questionnaires and can be further customised by the addition of new questionnaires to the Core system. Clinical trial sites interact with MOD-MS through a simple, intuitive site portal to enrol patients and optionally provide site-specific data through an integrated eCRF module.

Automated Features

Other MOD-MS features include automated virtual visit reminders by SMS and email; and platform-independent (smart phone or web) ePRO ensuring high patient retention. Behind the scenes the MOD-MS core automatically scores questionnaires in real time – as soon as they are completed – building a cumulative, pre-formatted datasheet that can be accessed instantly. MOD-MS can optionally deliver customised reports for individual study subjects back to participating clinical sites in real-time through the site portal.

MSS Support Services

Although a third party can operate MOD-MS, we offer optional support services including trial design, project management, Helpdesk provision and data management. Its state of the art web and interactive smart phone based architecture suits both pharmaceutical industry clinical trials and investigator-managed research studies.

Existing Medical Safety Systems/RxMx programs demonstrate an extraordinary success rate in engaging patients and physicians and achieve very high RMP adherence rates. This reduces human resource demand.

The RiskMx platform, developed and tested in a clinical trial, bridges the gap between pharmaceuticals and risk mitigation and is built for customisation to any medicine. At its heart, the RiskMx core continuously monitors pathology and other patient-level data using pre-defined algorithms that provide the basis for automated, real-time, healthcare practitioner-friendly REMS/RMP implementation. RiskMx is a transformative technology that adds a robust layer of medicine safety for patients, prescribers and the pharmaceutical industry.