Pharmaceutical softgel products

Over the 1990 and 2000 periods, 95%i of patents granted for pharmaceutical Softgel products relate to drugs or fill formulations and not to specific claims or improvements regarding shell formulations or manufacturing processes. On the surface, this would appear to indicate a mature technology, but as patents are public domain, and process patents are difficult to enforce, it is more likely that industry leaders are reluctant to pursue patents, except in unusual circumstances. In this process critical industry, it is more reasonable to expect that companies prefer to maintain technological advances as internal in-house matters for competitive reasons. 

Another example of the use of NMR for pharmaceutical QC is the screening of final products for active pharmaceutical ingredients (APIs) as well as binders, excipients, and contaminants. In softgel tablets, a major component is polyethylene glycol (PEG), seen in the NMR spectrum of an over-the-counter ibuprofen softgel product (Figure 3.76a). 

The standard Softgel shapes for oral pharmaceutical products are oval, oblong, and round. The size of the Softgel is represented by a numerical number, which represents its nominal capacity in minims (1 cc = 16.23 minims). For example, an 11 oblong Softgel can be filled with 8.5-11.0minims of fill formulation. 

Because of their special properties and advantages, Softgels are used extensively in many pharmaceutical, cosmetic, and nutritional products. The primary pharmaceutical applications include oral dosage forms, chewable Softgels, suppositories, and topical products. 

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