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Bringing Novel Delivery Technologies to the North American Market

Bringing Novel Delivery Technologies to the North American Market

Dec 06, 2019PAP-Q4-19-CL-020

Founded in 1998, Italian contract manufacturer Labomar provides novel quality, front-line solutions to its customers in the nutraceutical, food supplement, medical food, medical device and cosmetics markets. With the recent acquisition of Canadian CMO ImportFab, the company is now in a position to directly offer our proprietary delivery technologies to North American customers.

Pharmacy Roots

My family has owned a pharmacy in Istrana, in the province of Treviso, Italy for more than 100 years. I spent a lot of time in the pharmacy as a child and began working there as a young man. In speaking with customers, it was quite clear that many of the products on the market did not really meet their needs. To address this, I began developing products for the store, using a small laboratory in the pharmacy and eventually a GMP lab created in my family’s home.

Customers of the pharmacy liked the products, and soon there was demand for them at other pharmacies as well. Eventually, it was necessary to move to a bigger space, and Labomar was officially established in 1998.

Two Decades of Rapid Growth 

Over the last two decades, the company has grown significantly to produce nutraceuticals, supplements, medical foods, medical devices and cosmetics. Today, we have a network of five facilities, including our headquarters, three cutting-edge production sites with state-of-the-art machinery and technology, 16 transformation centers and 15 complete packaging lines and the Labomar R&D Center. We employ 200 people and have 13 registered patents. We support 180 customers, market products in 28 countries and have the capability to produce up to 30 million units per year.

Scientific research and the constant development of new, patented technologies are at the core of what we do.

Wide Range of Products and Services Focused on Well-Being

For Labomar, well-being is a wide-ranging concept: a good life philosophy that is built up day-by-day with safe and effective products. We also value a positive and stimulating working environment, in which passion and cooperation thrive.

This approach has led the development of many innovative, ready-to-market products targeting a broad array of therapeutic applications, such as gynecology, proctology, neurology, cardiology, gastroenterology, oncology, dermatology, wound care, orthopedics, pediatrics, eyesight wellness, weight management, cough and cold, and much more.

Labomar’s nutraceutical products are developed using patented technologies that increase the bioavailability of the active ingredients and regulate their absorption. Probiotic formulations from Labomar are based on probiotic species with proven scientific evidence for specific therapeutic areas.

Our medical devices (classes II A, II B and III) are intended for topical use and oral administration. Labomar developed formulations of foods for special medical purposes, which are intended to replace (either in part or totally) the foods eaten by persons suffering from metabolic or functional pathologies, with the special needs of these patients in mind, paying particular attention to the organoleptic aspects to enhance acceptability. Cosmetic products from Labomar are designed for resolving skin problems, as well as combating the signs of aging and improving physiological parameters.

Labomar also works closely with customers to develop customized and specific solutions, which can be formulated in many different types of dosage forms, including liquids (syrups, suspensions, emulsions, nanoemulsions, gels), tablets (regular, chewable, micro, orally dispersible, sublingual, coated, modified release, multi-layer) hard and soft gelatin capsules (powder, granules), powders (soluble, orally disintegrating, granulates) and topical products (rinse-off and no-rinse gels, creams, emulsions, drops). Packaging options include various types of blister packs, bottles, cases, jars, sprays, vials, stick packs, sachets and tubes.

The Labomar production sites have been designed to the highest quality standards, with technologies and criteria used in pharmaceutical plants. From the preparation of raw materials through bulk production, meticulous quality controls are implemented, and the processes and products are in compliance with GMP standards.

The acquisition of ImportFab raises the international turnover share of Labomar to approximately 50% and represents an additional step on our path of internationalization and further growth.

Highly Focused on R&D

At Labomar, we have a strong commitment to continued investment in research and development. Scientific research and the constant development of new, patented technologies are at the core of what we do. Approximately 5% of revenues annually are funneled to R&D. An entire division — Labomar Research — is dedicated to creating new, ready-to-market products based on new raw materials, formulations and release systems. The research team (approximately 10% of all employees) works daily on top-quality raw materials and innovative formulations and on producing rigorously scientific documentation.

In addition to regularly conducting market research and trend analyses, our scientists stay up to date on the latest scientific discoveries. This information is used to identify unique new raw materials and develop novel formulation approaches and delivery technologies. Prototypes are constructed and evaluated, with extensive documentation of all research efforts. Analytical methods are developed as needed, and stability studies are conducted to meet regulatory requirements.

When clinical studies must be conducted, materials for clinical trials are produced. Process scale-up to the pilot and commercial scale, as well as process validation, are performed in preparation for product launches. When appropriate, results obtained with new technologies are published in the scientific literature. To date, the R&D department has a portfolio of nine delivery patents and four patents for the protection of novel formulations.

Effective Proprietary Delivery Technologies

The nine delivery patents cover technologies designed to improve the delivery of functional components. For sublingual delivery, Labomar has developed three sublingual delivery technologies that enhance the delivery of lipophilic molecules insoluble in aqueous solutions to improve bioavailability and increase the speed of action.

Our nanoemulsion delivery system is formulated as a sublingual spray and achieves high vascularization of the sublingual mucosa for faster absorption. The system is a way to avoid the first-pass effect with active ingredients such as vitamin D3 and melatonin. Our absorbed nanoemulsion system (oral or water-soluble powder) improves the palatability of active ingredients with unpleasant tastes, such as coenzyme Q10 and resveratrol. Our sublingual nanotablets dissolve under the tongue to improve medication adherence and are ideal for poorly bioavailable lipophilic substances that are metabolized in the liver, such as resveratrol, vitamin D3 and vitamin E, which are specifically formulated to alleviate menopausal symptoms.

For probiotics, Labomar has developed a self-emulsifying anhydrous dispersion system, an oily liquid carrier that guarantees the survival of probiotics and increases their stability. It can be mixed with water or other liquids for easy administration, even to children. Our patented Rew Cap container for the administration of probiotics and unstable substances increases stability and ensures higher product quality. The unstable active ingredient is protected in the cap and then dispersed into the liquid formulation in the vial just before administration.

Labomar has also developed two novel enteric delivery technologies. Enterosoma, in the form of gastro-resistant tablets, comprises a selection of excipients designed to bypass the physiological constraints to intestinal absorption and is ideally suited for raw materials with poor bioavailability in the intestines, such as berberine and curcumin. Our Lipomatrix technology, meanwhile, delivers lipid components in tablet form, including boswellia resin and vitamin D3 and serenoa and ginger oils.

In liquid products, our natural (no preservatives) deep eutectic solvents (NADES), when mixed, create anhydrous liquids, allowing the delivery of substances that are insoluble or unstable in water in liquid form, such as luteolin, zinc and vitamin C, providing increased bioavailability. Our A.I.D. ionized water transportation system combines water with cutting-edge technologies to allow better absorption of active ingredients administered both topically (e.g., aloe) and systemically (e.g., amino acids).

Expansion into international markets, and in particular the North American market, is a fundamental step of Labomar’s development strategy for the coming years.

Patented Formulations

Labomar’s four patented formulations target a range of therapeutic applications. Coleosoma is a formulation based on excipients and catonized chitosan that alters the physiological absorption of dietary cholesterol and fats by enabling precipitation of bile salts and the reduction of fat emulsions, thereby limiting absorption of the latter in the intestine. It is used in tablets for controlling the blood lipid profile and for weight control.

Clinically tested Gastrosoma is a formulation in tablets and gels in stick packs for the treatment of symptoms of gastritis and gastroesophageal reflux. It contains a unique combination of excipients that dilute gastric acids, create a mechanical barrier for the prevention of gastroesophageal reflux, heal damaged mucosa and act as an antibiotic against Helicobacter pylori.

IronEC Purple, also clinically tested, increases the bioavailability of iron in a formulation with a pleasant taste and without typical side effects and is available as oral- and water-soluble powders, capsules and tablets. Dairy proteins and vitamins C and E maintain the active form of the iron throughout the digestive tract.

Patent-pending Probiosoma contains a culture medium specific for the delivery of prebiotics in tablet form. It not only prevents the fermentation of probiotic fibers, but also provides specific distribution in the colon mucosa and promotes colonization of probiotic growth. In addition, it can be adjusted for specific strains and has been shown to be more effective than Inulin.

Collaborating with Customers

Labomar seeks to be a benchmark for our customers who seek effective and innovative products. Our R&D team works closely with customers, supporting them in achieving their goals while sharing resources and expertise.

Close collaboration with customers is essential because they have extensive knowledge of their target markets and customers. Sharing this knowledge with Labomar enables us to best adapt our technologies to the specific needs of the product. As a result, together we are able to create the most value.

In addition to using our proprietary technologies, we are happy to incorporate our customers’ patented technologies into novel formulations to develop products. Our team of dedicated researchers has the expertise and experience to help optimize such formulations. Where appropriate, we are excited to form partnerships of various kinds to create the maximum value possible.

Expanding into North America

Expansion into international markets, and in particular the North American market, is a fundamental step of Labomar’s development strategy for the coming years. To that end, we have acquired 100% of ImportFab Inc., a Canadian company based in Montreal that has been operating in the North American pharmaceutical, cosmetic and nutraceutical market for 29 years.

ImportFab, which has been inspected by both the Food and Drug Administration and Health Canada, provides contract manufacturing and packaging services for liquid, semi-solid and cream pharmaceutical, cosmetics and nutraceutical products. The integration of their capabilities with Labomar presents a unique opportunity to increase the total turnover and company size, while expanding into new areas of the pharmaceutical market. We will now be able to bring our novel technologies and products to the United States, Canada and Mexico while also providing our customers with direct access to the North American market.

Since closure of the deal, we have been working closely with the leadership at ImportFab to build the foundations of a strong relationship. In the coming months, we will be focused on implementing common procedures and processes and installing new equipment necessary for transfer of our technologies to the ImportFab plant. With the combined capabilities, we will have an even greater ability to serve our customers targeting the North American market.

Continued Investment for Further Growth

The acquisition of ImportFab raises the international turnover share of Labomar to approximal 50% and represents an additional step on our path of internationalization and further growth. Going forward, we anticipate the formation of interesting collaborations, alliances and partnerships over the next five years and the need to use the empty space at the ImportFab facility to expand production capacity.

In the meantime, in addition to modernization of the ImportFab facility and installation of the equipment necessary to transfer our technologies, Labomar is expanding our headquarters and adding new production areas for nutraceuticals and probiotics in Italy. We are also investing in an R&D accelerator program that is designed to attract young people and talent from foreign countries with interesting ideas for the development of supplements, cosmetics, medical foods and other products.

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