Softigel Contract Development Services and Drug Delivery Systems
Softigel is Procaps’ strategic business unit for contract development services. The company supports healthcare and related businesses that develop, manufacture, and commercialise pharmaceutical products.
Softgel capsules for the drug development industry
Produced in Colombia, Softgel capsules are have soft gelatin capsules and advanced delivery technologies. They are produced alongside nutritional supplements, veterinary products, and cosmetics.
The company also has facilities in Brazil, Colombia, and Venezuela.
With manufacturing sites in South Africa, Softigel offers various pharmaceutical dosage forms, shapes, and colours, in small to large-scale batches for 38 different countries worldwide.
Softigel focuses on difficult-to-manufacture drugs and aims to capitalise on business opportunities in generic and highly regulated pharmaceutical markets, especially in niche segments with limited competition.
Strong analytical support and expertise in new molecular entities (NME) for highly regulated markets are also available. The company houses a fully integrated product development services (PDS) unit.
Drug dosage systems
Softigel offers access to delivery systems such as novel technology for fixed dose combinations Unigel and Versagels, which provides a new approach to soft capsules without animal derivatives.
Other products include G-Tabs gelatin coated tablets, twist-off capsules, nutritional gummies, omega-3 high-concentrates, tablets, powders, creams, ointments, gels, and hard gel capsules.
The company provides pharmaceutical regulatory support and value-added marketing services. All of its plants fully comply with current good manufacturing practices (cGMP).
The softgel facility is approved by US Food and Drug Administration (FDA) and Medicine and Healthcare Products Regulatory Agency (MHRA). Softigel delivers services to a range of pharmaceutical clients, including Pfizer, Sanofi, Boehringer Ingelheim, and Bayer.
Manufacturing of pilot batches for softgels and tablets
The manufacturing facilities cover product lifecycle phases from early development to commercial and offer single and multiple drug dosage systems.
Procaps’ pilot plant facility for the manufacturing of experimental and pilot batches for softgels, liquids, and tablets uses equipment that replicates lab-scale and small-scale non-good manufacturing practices (GMP) and GMP batches, up to full-scale commercial GMP.
Clinical trial manufacturing
The product development team provides clients with access to formulation and processing clinical trial manufacturing, scale-up, analytical development, and regulatory support for markets including the US, Europe and Latin America.
The company assists clients from Phase I to registration and large-scale commercial production.
Softgel dosage forms have a range of benefits, including:
- Enhanced bioavailability for low-solubility / low-permeability compounds
- Life cycle management extension for drug products
- Low-dose and high-potency compounds
- Uniformity of dosage
- Lipid formulations, including improved, self-emulsifying active pharmaceutical ingredient (API) formulations
Products and Services
Softigel's chewable softgels are available in different shapes and flavours, offering a solution and line extension to existing products
Enteric Coated Softgels
Enteric-coated softgels can stabilise acid-sensitive products. Its coating delays the onset of action, improves tolerance, and reduces poor aftertastes.
G-tabs™ is a technology for the coating of tablets with either a one or a two-toned color gelatin. They can also be printed or not printed.
Gummies for Chewable Supplements and Pharmaceutical Applications
Softigel's gummies are made from sweeteners and gelatin, which can be modified to any shape, colour, or flavour.
Hormones for Replacement Therapy and Birth Control
Production of hormones for replacement therapy and birth control must involve strict control to ensure exact dose and balance
Omega-3 Fish Oils and Capsules
Softigel is dedicated to manufacture, research and development of omega-3 extracts from fish oil.
Tablets, Powders, and Other Drug Delivery Forms
Softigel's products use a variety of delivery methods, including tablets, powders, syrups, suspensions, creams, drops, and emulsions.
A twist-off capsules' shell is composed of two pieces, a body and a cap.
Unigel™ is an oral dosage form where tablets, granules, pellets, or capsules are placed inside a large, soft gelatin capsule.
Versagels™ are free from animal derivatives, which means that they are suitable for vegetarian diets, as well as certain religious and cultural diets.
Stability Issues Related to Soft Gelatin Capsule Development
Stability issues are a challenge for formulators. The reactivity of formulations depends on many factors, although it is generally recognised that labile drugs in aqueous forms are sometimes the worst cases.
Softigel by Procaps Brochure
Procaps is one of the world's largest softgel companies, specialising in the production and development of advanced gelatin-related technologies.
Go Beyond With Your Discoveries with Softigel Product Development and Contract Manufacturing Services
Part of the Procaps Group and one of the world's largest manufacturers, Softigel shows its deep knowledge of gelatin formation in its softgels expertise.