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Gelatin capsule Gel Deliveries


At Softigel, we offer much more than  traditional softgels, including everything  from a single unit dosage form, to multiple delivery systems in a single dose.

Softgels

Softgels are an effective delivery system for oral drugs, especially those with low solubility and/or permeability (BCS Classes II, III and IV).  The softgel fill solution can contain ingredients which help increase solubility and permeability. These ingredients are mainly liquids or semisolids which are difficult to incorporate into other solid dosage forms, like tablets. 

Formulation Strategies:

In order to improve bioavailability, some strategies focused on increasing solubility/permeability are depicted:
  • Hydrophilic formulations
    • Co-solvency (e.g. Nimodipine 30 mg)*
    • pH related solubilization (e.g. Ibuprofen 200mg, 400 mg, 600 mg and Cetirizine  2.HCl 10mg)*
  • Lipophilic formulations
    • Lipid solutions (e.g. Dronabinol 2.5 mg, 5 mg, 10 mg)*
    • Self emulsifying drug delivery system (e.g. Isotretinoin 10 mg, 20 mg, 30 mg, 40 mg)*
    • Particle size reduction (e.g. Progesterone 100 mg, 200 mg )*
*These are examples of some of the products developed by our company

Softgel advantages:
 
  1. Improve bioavailability of poorly water-soluble and poorly permeable compounds.
  2. Containment strategy for the manufacturing of highly potent compounds.
  3. Improve content uniformity of low dose compounds.
  4. Tamper evident.
  5. Counterfeiting prevention.
  6. Suitable for liquid and semisolid APIs.
  7. Easier to swallow.
  8. Improved patient acceptance and preference.
  9. Many shapes, sizes and colors for differentiation.
Softigel is an ideal partner for softgels which satisfy the following characteristics:
  • Pharmaceutically acceptable for oral use.
  • Sufficiently soluble to dissolve a given dose in a small volume.
  • Yield a fill formulation that is stable and compatible with the shell materials.
  • Prevent precipitation of the solubilized compound during manufacturing, shelf-life, and if possible, upon contact with the aqueous environment in vitro (dissolution) and in vivo (GIT).  (Why is this point in bold when the others are not?)
  • One- or two  colors available.
  • Ribbon printing.
In-house workshop for manufacturing our own molds, machines and spare parts. 

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Soft gelatin capsule Traditional Softgels Soft gelatin capsule Traditional Softgels Soft gelatin capsule Traditional Softgels
Soft gelatin capsule Traditional Softgels Soft gelatin capsule Traditional Softgels Soft gelatin capsule Traditional Softgels
Soft gelatin capsule Traditional Softgels Soft gelatin capsule Traditional Softgels Soft gelatin capsule Traditional Softgels
Soft gelatin capsule Traditional Softgels Soft gelatin capsule Traditional Softgels

Twist off softgels

A soft gelatin capsule with twist-off cap allows access to a measured dose for topical and oral applications. For example,  Progesterone twist off 25mg soft gelatin capsules offer more accurate dosing for topical application  than Progesterone topical gel.

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Twist off softgels - Softigel Twist off softgels - Softigel Twist off softgels - Softigel
Twist off softgels - Softigel Twist off softgels - Softigel Twist off softgels - Softigel
Twist off softgels - Softigel

Unigel™ Softgels

One dosage form, many benefits. A unique oral dosage form that allows having tablets, capsules, granules or pellets inside a single, larger soft gelatin capsule.


Unigel™ is the only patented technology for fixed dose combinations which incorporate the benefits of soft gelatin capsules.

Benefits of Unigel include:
  • Single or Multiple active ingredients with different release profiles (sustained and immediate) and release sites (gastric and intestinal).
  • Multiple active ingredients with chemical incompatibility concerns.
  • Multiple active ingredients where at least one is a liquid or a semisolid.
  • Any combination of the above.
  • Reduces number of drug intakes, increasing patient compliance.
  • Patent challenge opportunities in a new dosage form.
  • Life cycle management extensions.
  • Highly differentiated consumer product appeal.
  • Available in different sizes and shapes.
Some ideas for the use of Unigel:
  • Cardiovascular:
    • Fish Oils plus statins, and Fish Oil plus aspirin are great examples of potential Unigel combination products. 
  • Respiratory:
    • Solubilized cetirizine and sustained release pellets of pseudoephedrine or phenylephrine.
  • Gastric:
    • Enteric-coated omeprazole pellets in a liquid suspension containing magnesium hydroxide. 
  • Analgesic:
    • Soft gelatin capsule containing solubilized ibuprofen and an extended release tablet of the same API.

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soft capsule Unigel™ soft capsule Unigel™ soft capsule Unigel™
soft capsule Unigel™ soft capsule Unigel™ soft capsule Unigel™

G-tabs™ gelatin coated

Technology for tablets coated with a one or two-toned color gelatin, printed or not printed. 

Benefits of G-tabs include:
  • Masking unpleasant flavors and odors
  • Ease of swallowing
  • Ideal for APIs that can irritate the esophageal mucosa when they are incorporated in an immediate release tablet, e.g., biphosphonates
  • Ideal for double blind clinical studies
  • Ideal for improving stability of photosensitive APIs
  • Preventing counterfeiting 
  • Custom branding
  • Easy recognition of tampering

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tablets G-tabs ™ tablets G-tabs ™ tablets G-tabs ™
tablets G-tabs ™ tablets G-tabs ™

Versagels™ softgels

Another of Softigel´s patented technologies, these polysaccharide-based  soft shell capsules are free from animal derivatives, and contain carrageenan, modified starch, plasticizers and water.  They offer opportunities to bring more products to market, better acceptance by religious and vegetarian groups, and compatibility with a broader range of high pH fill formulations. Vegetarian capsules technology  may be applied to traditional Softgels, G-Tabs™, and Unigels™.
  • Same advantages as  Soft Gelatin Capsules, but free of animal derivatives.
  • Available in the same range of shapes and sizes as Soft Gelatin Capsules.
  • Compatible with current types of softgel fill contents but with a broader acceptable pH range.

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soft capsule VeggieGels™ soft capsule VeggieGels™

Enteric Coated Softgels

The best way to stabilize acid-sensitive drug products, to improve tolerance, to delay onset of action and to reduce aftertaste. 
  • Protect acid-labile APIs
  • Avoids gastric irritation and reflux because the API is not delivered in the stomach (especially desirable for APIs like fish oil or garlic oil)
  • Target drug delivery in the small intestine which is preferred to treat intestinal disease

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Enteric Coated Softgels

Hard Gelatin Capsules

Capsules where the shell is composed of two pieces, a body and a cap, containing either a blend of powders or liquid fill formulations. The formulator is able to prepare products that have specific rapid, controlled, or modified release characteristics.  Hard capsules can be filled with formulations that have a wide range of physical properties from dry solids to non-aqueous solutions.

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Hard Gelatin Capsules Hard Gelatin Capsules Hard Gelatin Capsules
Hard Gelatin Capsules

Chewable Softgels

With new ingredients, special shapes and flavors, Softigel introduces this new concept in chewable softgels as a solution and line extension to existing products.
 
Characteristics:
  • Conveniently administered without water.
  • Portable dosage form that eliminates messy liquids.
  • Pleasant tasting, helps mask tastes and odors.
  • Can be formulated in a range of textures.
  • Offer a great number of nutritional benefits such as improving health and increasing acceptance by patients, adults, pets and specially children.

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