Lactose is a sugar, a slightly-sweet sugar. It is only about one-seventh as sweet as sucrose, ordinary table sugar. Oddly enough, this is a good thing to many in industry. Lactose allows a bit of pleasant sweetness to be added to products, without overwhelming them with an overly-sweet taste. Commercial bakers can sprinkle lactose on the tops of bread and let it caramelize to a beautiful golden-brown. Food processors can add lactose (or whey, which is mostly lactose) to add taste and texture to foods without affecting the primary taste of the food. Best of all, lactose is made from whey, and whey is a waste product in the cheese-making process, so it's really cheap.
That's why lactose is used so often in pill-making. The extremely tiny amount of actual working ingredient in a medication needs to be surrounded with fillers that bulk it out to be large enough to handle. A substance that is mostly tasteless but with just enough sweetness to balance out the bitter taste of many medications is great. That lactose can be formulated to break down in the stomach to release the medication makes it nearly ideal.
Literally hundreds of branded prescription medications use lactose as a part of their formulations. If you add in generics and over-the-counter drugs, you probably have thousands of medications that include lactose.
And there will soon be more rather than fewer pills that use lactose.
Phil Taylor on DrugResearcher.com wrote Roquette wins US patent for Starlac in novel dosage form about a new and improved way to dispense medications.
French company Roquette has been awarded a US patent for a dissolve-in-the-mouth drug delivery technology that makes use of its novel Starlac excipient.
Use of the excipient could allow the creation of tablets that are hard and resistant to damage during handling, yet still disintegrate quickly in saliva after dosing.
The US patent, awarded to Roquette earlier this month, covers a solid dose form based on lactose and starch, the constituents of Starlac excipient, alongside one or more active pharmaceutical ingredients (APIs).
Xavier Duriez, senior project manager at Roquette, told in-PharmaTechnologist.com that almost all ODT products on the market use mannitol as a diluent, but that in some cases Starlac could be used as a good alternative.
"Starlac is preferred for ODT and chewable formulas where palatability is a 'must'," he said, adding that the excipient provides a creamy mouthfeel that mannitol doesn't provide.
Starlac, a mixture of 85 per cent lactose and 15 per cent natural corn starch, was first introduced in 2002.
Of course, the mere granting of a patent doesn't mean that any products using Starlac will hit the market any time soon. But unless there is a serious bug with the project, it's too good an idea not to come to pass.
What does this mean for those who are lactose intolerant? Not as much as you might think. Only a tiny amount of lactose is present in any one pill. One study I read estimated that the average pill had 25 mg of lactose. You'd need to take 480 such pills to equal the lactose in an eight-ounce glass of milk at that rate.
A very few people might still be bothered by this tiny amount, especially if they have to take many such pills each day, as the elderly or those with serious illnesses must do. All I can suggest is to take a lactase pill along with the medication to see if that helps.
Those with a dairy allergy also need to be somewhat concerned, but with the same caution. Medical-grade lactose is extremely pure and not likely to be contaminated with the dairy protein that causes problems. Extremely anaphylactic people should certainly talk with their doctor before taking any pills with lactose. Those with lesser allergies and symptoms probably can take pills that contain lactose with no problems. But certainly check to see what alternatives there are.