The real skinny on delivery systems

You hear a lot about delivery systems in the supplement world. Brands make a lot of noise about why their product is better because it contains some reformulated version of a familiar compound, or a novel way of getting it into the body. Some of that noise is real chemistry. Some of it is patent extension dressed up as innovation. So here is how to think about delivery systems, with my opinion on the softgel format for fat soluble nutrients.

The patent extension playbook

What started as a pharmaceutical industry tactic to extend patent life on aging drugs has migrated into the supplement industry. The pattern works like this. A compound has been studied at a standard formulation. The patent is running out, or in the supplement context, the compound is no longer proprietary. The manufacturer reformulates the compound, calls the new version enhanced bioavailability or rapid release or microencapsulated, runs a small study showing some measurable difference in blood levels, and now has a marketing platform.

The studies almost never use clinical outcomes as the endpoint. They use blood levels, urinary excretion, or some other surrogate. A higher peak blood level looks good on a label. It does not always translate into the person feeling better or being healthier. It often does not.

That is not a reason to dismiss every delivery system claim. It is a reason to ask the right question. Does this delivery system actually produce a different clinical effect, or does it just produce a different lab number.

Why I prefer softgels for fat soluble nutrients

For most fat soluble supplements, including CoQ10, fish oil, vitamin D, vitamin E, and curcumin, the softgel is my preferred delivery format. The reasons are not all that exciting, which is part of the point.

• The softgel is a single sealed unit. No two halves to come apart, no capsule shell to disintegrate before the contents reach the small intestine.
• It is easy to swallow, particularly for older adults who often struggle with hard tablets.
• It is tamper resistant.
• The contents are protected from oxidation, photosensitivity, and ambient moisture more effectively than in a standard capsule.
• No fillers or texturizing agents are needed to make the format work, which means fewer ingredients on the label that have nothing to do with the active compound.
• Bioavailability is generally improved compared with hard tablets for fat soluble compounds. The compound is already in solution in the carrier oil. Dissolution is not a rate limiting step.
• Enteric coated softgels release in the small intestine rather than the stomach, which solves taste, smell, and pH stability problems for compounds like fish oil.
• Dose to dose uniformity is high enough that softgels can meet a pharmaceutical grade specification. Most hard capsules cannot.

None of this is exotic. The softgel has been a workhorse format in pharmaceuticals for decades. The supplement industry has caught up to that standard for the fat soluble category, which is good.

Where softgels are not the right answer

Water soluble vitamins, B complex, vitamin C in most forms, water soluble polyphenols, do not particularly benefit from a softgel format. They are better delivered in capsules, powders, or in some cases sustained release tablets. Some compounds also have to be liposomal or otherwise specially formulated to survive gastric acid, in which case the right delivery system is not a softgel but a more specialized format.

The rule of thumb is that fat soluble actives in oil suspension belong in softgels. Water soluble actives belong elsewhere.

How to evaluate a delivery system claim

• Ask what specific problem the new delivery system solves. Better absorption, faster onset, sustained release, reduced GI side effects. If the answer is vague, the claim is decoration.
• Ask what the clinical evidence shows. A study on peak blood level is interesting but not sufficient. A study on a clinical endpoint, or at minimum a downstream marker the active compound is supposed to move, is the bar.
• Compare on a per dose basis. A delivery system that improves absorption by 30 percent at twice the cost is not necessarily a better deal than the standard formulation at the same total bioavailability.
• Ignore the marketing flourishes. Phrases like advanced bioavailability platform, micro encapsulated nanotechnology, and proprietary absorption matrix usually contain very little chemistry.

The softgel earns its place not by being novel, but by being a quietly competent solution to a real set of problems. Most of the time, the unflashy answer is the right answer.

— Doc