Experts

Solid Dosage and Tabletting

Contact Center Expert: Fred Rowley, Solid Dosage Training, Inc.

Fred Rowley holds a B.S degree in Biochemistry from the University of Santo Thomas. He is currently Guest Speaker of Solid Dosage Training, Inc. He is also director of manufacturing technical support for a leading pharmaceutical firm. He has held senior manufacturing and technical positions at Stayner Pharmaceuticals, Shaklee Corp., Syntex Laboratories, Alza Corp. and Weider Nutrition International.

Specifications for tablet weight
I recently read about an FDA observation of a company that, when doing in-process control of its tablet press, weighs 10 tablets at certain intervals and records/plots the average of those 10 tablets. Thus, the company does not record individual tablet weights, which means that it does not know whether any individual tablets are out-of-specification. If an NDA and product specs do not contain tablet weight, then is this a valid FDA or other auditor observation of an in-process control measurement?
Category: Solid Dosage and Tabletting

Does tablet thickness affect hardness?
Does tablet width and thickness affect tablet hardness? What other factors can influence this?
Category: Solid Dosage and Tabletting

Sodium alginate in film coating
How do you use sodium alginate in the film coating of tablets? What kind of formulation could be used for 100 Kg of tablets?
Category: Solid Dosage and Tabletting

Advantages of bin blenders
What are the advantages and disadvantages of the closed-in bin blender, and what are the characteristics of the granules made? Are they consistent and easy to replicate?
Category: Solid Dosage and Tabletting

Applying glaze in a coating pan
Can pharmaceutical glaze be applied to tablets in a Thomas "Accela Cota" coating pan? If so, what provisions would need to be in place?
Category: Solid Dosage and Tabletting

Moisture content in tablets
I wish to find out how moisture content in granules can affect the physical parameter of an uncoated tablet.
Category: Solid Dosage and Tabletting