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Posts with tag drug delivery

Generex Regulatory Affairs Request

At the request of the Regulatory Affairs Manager at Generex, I am posting the following to defend the accuracy of the packaging and the claim of the product. The initial blog addressed a product called Glucose RapidSpray. The reader feedback, as well as the regulatory affairs response, is listed below. In no way, does Generex imply this product is to be used to treat hypoglycemia.

The comment to the original post stated:

The nutritional label on the product (available as a PDF on their web site) says the product has 188mg of carbs (or .188g) per serving (5 sprays). A typical glucose tablet has 4g... that's about 21x more carbs in a single glucose tablet than in 5 sprays of RapidSpray. Considering you typically use at least 15g of carbs to treat hypoglycemia, you would need around 80 sprays to get 15g of carbs into your system! When you take into account the amount of sprays you need, the calorie count isn't very much different from glucose tablets.

Read the label carefully, and be very careful using this!

The response from the Manager of Generex Regulatory Affairs states:

The product, Glucose RapidSpray™, is to be taken at the first sign of needing additional glucose in the diet, either between meals, during exercise, and/or before bedtime. It is not intended to take people out of full hypoglycemic states that normally a full tube of glucose gel or a full dose of Glucose tablets would be needed for. Glucose RapidSpray™ product is meant to be a complement to meals in order to help with glucose levels. As such, a direct correlation of carbs associated with Glucose RapidSpray™ and typical glucose tablets or gel is not warranted based on the intended use of the product. If usage of the product is maintained by taking Glucose RapidSpray™ at the first sign of needing additional glucose, then the Nutritional Facts stated on the package labeling is adequate for determining caloric intake (be it 5 sprays, 10 sprays, 15 sprays or whatever is taken to address the situation).

I consider the proactive response of Generex a good sign of how a company is run. Without needing to do so, Generex went above and beyond the call to address an open forum about the efficacy and accuracy of the product. This is the kind of interaction that convinces me a company cares! Good job, Generex! Lest I NOT hold my breath for Eli Lilly to return my call about Super Insulin. Novo Nordisk was far more receptive to address my interests, as a diabetic. Stay tuned for my follow-up on the Eli Lilly vs. Novo Nordisk – Who Love You, Baby!?!

First Metformin Gum Patent

Sink your teeth into this one. Generex, the company that is quickly making a name for itself as the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced that it has been granted the first patent for its medicinal gum platform. The patent is titled Compositions for Oral Transmucosal Delivery of Metformin. It covers claims to the composition, processes, and methodologies for the delivery of an oral transmucosal metformin composition via the oral mucosal membrane for absorption. Long story short: you chew it.

Metformin is a generic drug used to regulate blood sugar levels by reducing the amount of glucose produced by the liver. The popular brand names of Metformin include: Glucophage, Diabex, Diaformin, Fortamet, Riomet, and Glumetza. Metformin is the only anti-diabetic drug that has been proven to reduce the cardiovascular complications of diabetes, as evidenced in a large study of overweight patients with diabetes. Metformin has been in use around the world for more than 30 years. It remains the most prescribed drug for Type-2 diabetes, a testimony to its efficacy and its prominent place in diabetes therapy.

Rose C. Perri, the Generex Chief Operating Officer commented, "we are very pleased to receive the first patent for our metformin gum product, a product that compliments our flagship product, Generex Oral-lyn™, and related diabetes pipeline". On a personal note, when I first learned about this development from the masterminds at Generex I was definitely excited. But now that the train has left the station, I'm happy to share this news with the gum-chewing, metformin-taking, diabetes population. It's all about the delivery and this one is definitely special.

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