Solid oral dosage forms, analysis

It is clear that, although it is not a common issue for solid oral dosage forms, excipient background does need to be considered in method development for impurity analysis even in the typical-dose formulation. 

The pharmaceutical analysis of finished solid oral dosage forms is discussed in Chapter 6 from the standpoint of what makes this type of delivery form unique and successful (i.e., the physical properties and the state of the drug substance... 

This technique could be extremely important for assessing the controlled-release properties of a solid oral dosage form. The homogeneity and quality of the manufacturing process could be determined. Also, this technique could be applied to the analysis of the surface of beads, tablets, and granulations, allowing the chemical composition of more than one layer to be evaluated. 

Pharmaceutical analysis needs more functionality tests for solid oral dosage forms. After all, we know and have a record of the amount of drug added to the batch. The industry needs to take advantage of the modernization of the techniques described within and routinely apply them to in situ analyses... 

When powder samples are involved, sampling should ensure that a representative portion is used in individual tests. For solid oral dosage form products, testing should be conducted on an appropriately sized composite of, for example, 20 tablets or capsules. Similar sampling considerations, such as homogenization or solubilization of the entire sample, apply to other materials that may not be homogeneous after exposure (e.g., creams, ointments, suspensions, etc.). The analysis of the exposed sample should be performed concomitantly with that of any protected samples used as dark controls if these are used in the test. 

Moreno Galvez A, Garcia Mateo JV, and Martinez Calatayud J (2002) Simultaneous dissolution profiles of two drugs in solid oral dosage forms by a FIA manifold provided with a single detector. Journal of Pharmaceutical and Biomedical Analysis T7-. 1027-1036. 

Zeider, JA., Shen, Y., Baker, C., Taday, P.F, Pepper, M., and Rades, T. (2007) Analysis of coating structures and interfaces in solid oral dosage forms by three dimensional terahertz pulsed imaging. /. Pharm. Sci., 96 (2), 330-340. 

In the critical variables analysis phase, a statistical experimental design is created (e.g., factorial, Box-Behnken) intended to assess critical formulation and process variables in relatively small-scale manufacture. In these studies, the ranges of composition variables are chosen to at least encompass those noted in the recommendations of the AAPS-FDA Workshop on Scale-up of Immediate Release Oral Solid Dosage Forms or SUP AC. This phase is usually preceded by a development phase during which variables and levels to be studied are determined and the exact method of manufacture is established. Experimental formulations are assessed at least in terms of dissolution performance, content uniformity, and weight variation. On the basis of these studies, the specific formulations to be manufactured for biostudy are selected. 

Rosen, J. M., O Leary, M., Eotino, W, Ryall, R. R., and Gehrlein, L. PyTechnology robotic sample preparation procedures for potency and content uniformity analysis of ceflxime, an orally active cephalosporin solid dosage form. Adv. Lab. Autom. Rob. 5 363-379, 1989. 

Breaking points are the availability of the raw materials and primary containers of reliable suppliers, the feasibility of analysis of the drug substance and the preparation and the availability of equipment. As an example, preparation processes such as tableting, freeze-drying or aseptic production are accessible in a few pharmacies. The preparation of oral solids with controlled release is not possible in pharmacies mainly to lacking equipment (fluidised-bed techniques and instrumental analysis, etc). Working with radiopharmaceuticals also requires very specific facilities, as is the case with preparation of solid dosage forms with hazardous substances. 

Oral Solid Dosage Forms (OSDF) and Pharma Excipients Market for Polymers (MCC, HPMC, CMC, Ethyl Cellulose, Povidone and Others), Alcohols (Glycerin, Sorbitol, Mannitol, Propylene Glycol), Minerals (Clay, Silicon Dioxide, Titanium Dioxide) and Sugars (Lactose, Sucrose) - Global Industry Analysis, Size, Share, Trends, Analysis, Growth and Forecast, 2012 - 2018,2013. 

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