Solid dosage form manufacture

An important specification for solid dosage form manufacture is the dissolution factor. The product is formulated and manufactured such that it will have the specified dissolution profile for maximum effectiveness. 

There are three types of lubricants employed in solid dosage form manufacture. The first class of lubricant is the glidant. The flow properties of a powder can be enhanced by the inclusion of a glidant. These are added to overcome powder cohesiveness. The two other classes of lubricant are antiadherent excipients, which reduce the friction between the tablet punch faces and tablet punches, and die wall lubricant excipients, which reduce the friction between the tablet surface and the die wall during and after compaction to enable easy ejection of the tablet. The level of a lubricant required in a tablet is formulation dependent and can be optimized using an instrumented tableting machine. 

Solvates formation during the solid dosage form manufacture... 

Hancock, B.C. Ketterhagen, W.R. (2011) Discrete element method (DEM) simulations of stratified sampling during solid dosage form manufacturing. International Journal of Pharmaceutics 418, 265-272. 

The production of effervescent tablets is first of all a conventional solid dosage form manufacturing process, which has to be taken into consideration, due to the special characteristics of the product and some unusual features. 

Solvates formation during the solid dosage form manufacture During the granulation process it is possible that the DS (occasionally the excipient) could transform into a solvated crystalline structure (solvate, hydrate). During the drying process, different situations can occur ... 

In the time path solid dosage forms (tablets or capsules) must eventually to be manufactured for the clinic... 

Colorants do not contribute to therapeutic activity, nor do they improve product bioavailability or stability. Indeed, they increase the cost and complication of the manufacturing process. Their main role is to facilitate identification and to enhance the esthetic appearance of the product. In common with all material to be ingested by humans, solid dosage forms are severely restricted in the coloring agents that are allowable. This situation is complicated by the lack in international agreement on an approved list of colorants suitable for ingestion. 

Oral Administration. Oral administration is the preferred route of administration. There is a general consensus among pediatricians and parents that children younger that 5 years of age have great difficulty with, or are unable to swallow, a solid oral dosage form. Manufacturers, therefore, have developed liquid formulations for many of the commonly used pediatric products. The liquid dosage form, however, is not free of problems. Liquid products are often unstable and have short expiration dates accurate measurement and administration of the prescribed dose is also a problem, especially in infants. 

Table 2 Properties of the Crystals or Particles that May Be Modified by the Processing Stresses that Are Imposed During the Manufacture of Solid Dosage Forms...

In the present work, such a systematic approach to the physical characterization of pharmaceutical solids is outlined. Techniques available for the study of physical properties are classified as being associated with the molecular level (properties associated with individual molecules), the particulate level (properties pertaining to individual solid particles), and the bulk level (properties associated with an ensemble of particulates). Acquisition of this range of physical information yields a total profile of the pharmaceutical solid in question, whether it is an active drug, an excipient, or a blend of these. The development of a total profile is a requirement for successful manufacture of any solid dosage form. 

A pulsed system, called Time-Clock System, has been developed. It comprises a solid dosage form coated with a hydrophobie surfactant layer to which a water-soluble polymer is attached to improve adhesion to the core [66]. The thickness of the outer layer determines the time required to disperse in an aqueous environment. Following the dispersion of the outer layer, the eore becomes available for dispersion. An advantage is that eommon pharmaceutical excipients can be used to manufacture this system. Studies performed on human volunteers showed that the lag time was not affeeted by gastrie residence time. Furthermore, the dispersion of the hydrophobic film was not influenced by the presence of intestinal digestive enzymes or by the mechanieal aetion of the stomach. 

This need is addressed in part by NIR-CI, in that it offers the ability to obtain high fidelity, spatially resolved pictures of the chemistry of the sample. The ability to visualize and assess the compositional heterogeneity and structure of the end product is invaluable for both the development and manufacture of solid dosage forms. NIR chemical images can be used to determine content uniformity, particle sizes and distributions of all the sample components, polymorph distributions, moisture content and location, contaminations, coating and layer thickness, and a host of other structural details. "... 

SUPAC-IR/MR Immediate release and modified release solid oral dosage forms manufacturing equipment addendum (January 1999). 

Part IB Specific requirements for manufacture of oral solid dosage forms (tablets and capsules)... 

---