Solid dosage forms clinical manufacture

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

Fig. 3 shows a pilot plant layout with restricted personnel access. This design would support the development and clinical manufacture of solid dosage forms, liquids, semisolids, aerosols, and sterile products. Multipurpose rooms are incorporated in each area to maximize the use of portable equipment, and scale factors similar to those shown in Table 1 are employed. Isolation suites are indicated in the manufacturing area their purpose and design are discussed in more detail later. The sterile area is isolated from the main corridor by the interior corridor design. At the far left, the main corridor provides access for future facility expansion, if necessary. 

Oral solutions can be developed for either early Phase I clinical trials of a new chemical entity (then further develop a solid oral dosage form), or for intended commercial manufacture. Oral solutions for early clinical trials are developed to rapidly introduce a new chemical entity into human trials, because an oral solution can be the simplest formulation to develop and manufacture within a... 

Most industrially manufactured herbal medicinal products are oral dosage forms. Liquid preparations (fluid extracts, tinctures) have advantages as to dose flexibility but an unacceptable taste can be a problem in clinical practice. The latter can be circumvented by using solid oral dosage forms containing a dry extract of the herbal medicine. Tablets and capsules with pulverized herbal active substances are also available commercially. Some herbal medicines have to be taken as loose powders. A tea can be prepared from pulverized herbal medicines, either l(X)se or in teabags, or from an instant herbal tea [4, 5]. 

Once the clinical trial material is manufactured, it is analyzed for purity, impurities, and solid form. The purity and impurity analyses are done using conventional high performance liquid chromatography (HPLC). The solid form can conveniently be determined using solid-state NMR or X-ray powder diffraction. Solid-state NMR is particularly attractive for dosage forms involving capsules since the entire capsule can be placed in the instrument. 

---