Capsule apparatus

The lower plate can be moved up and down relative to the frame. The upper plate is mounted with a hinged transparent cover that can be fixed. The upper plate, as weU as the middle plates, is perforated with 50-100 holes for the capsules. Apparatus brands that are used frequently are Capsunorm (plastic type), Feton (plastic type), Loeco (polycarbonate), Loetschert (aluminium). Optima (aluminium) and Profill (aluminium). The overall width of the holes depends on the capsule size. Each apparatus is dedicated to a fixed capsule size. The holes in the upper plate are tapered to the underside, so only the lower halves of the capsules fall through, see also Fig. 28.18. 

A regular test to assess whether the capsules apparatus still works correctly is described below ... 

The error in the determination of phase transition temperatures in a capsule apparatus depends on the rates of phase reaction and variations in temperature as well as on thermal gradients along the capsule and between the capsule and die wall of furnace. The reproducibility of the temperature of such phase transitions as liquid immiscibility or critical phenomena is in the range of several tenflis of a Kelvin for the best measurements. However, an error can reach 1-2 K in most available publications on salt solubility measurements. 

Figure 6. Dissolution profdes of HPMC capsules. Apparatus Paddle, 50 rpm. Stored condition 40°C and 75%RH. initial, one month. A two months.

Over the years, dissolution testing has expanded beyond ordinary tablets and capsules—first to extended-release and delayed-release (enteric-coated) articles, then to transder-mals, multivitamin and minerals products, and to Class Monographs for non-prescription drug combinations. (Note at the time, sustained-release products were being tested, unofficially, in the NF Rotating Bottle apparatus). 

In the belt apparatus, the sample is contained in a noble metal capsule (a BN or MgO container is used for chalcogenides) and surrounded by pyrophyllite and a graphite sleeve, the latter serving as an internal heater. In a typical high-pressure run, the sample is loaded, the pressure raised to the desired value and then the temperature increased. After holding the pressure for about 30 minutes, the sample is quenched (400 K s ) while still under pressure. The pressure is then released after the sample has cooled to room temperature. 

Solid oral dosage forms containing new chemical entities (NCEs) are commonly formulated into tablets or capsules as their first market image formulation. Subsequent drug product line extension development on these NCEs may evaluate more specialized drug delivery systems. Dissolution testing of standard oral tablets or capsules will commonly utilize the paddle or basket apparatus. In this chapter we focus primarily on the development and subsequent validation of dissolution testing methods that use these two devices. 

Apparatus. The nature of the dosage form will determine the type of dissolution apparatus that will be used for method development and validation. The following questions must be asked when selecting the dissolution apparatus. Is it a capsule Will a sinker be required How stable is the drug substance after dissolution in the medium Is the formulation an immediate release or an extended release formulation Is this a transdermal patch ... 

Dissolution testing should be carried out in USP Apparams 1 at 100 rpm or Apparatus 11 at 50 rpm using 900 ml of the following dissolution media (1) 0.1 N HCl or Simulated Gastric Fluid USP without enzymes (2) a pH 4.5 buffer and (3) a pH 6.8 buffer or Simulated Intestinal Fluid USP without enzymes. For capsules and tablets with gelatin coating. Simulated Gastric and Intestinal Fluids USP (with enzymes) can be used. 

High-pressure treatments were carried out in two units a hot isostatic press (HIP) and a multiple anvil-type high-pressure generator. The powder sample for HIP treatment were pelletized and sealed in Ag tubes in vacuo, and was then sintered at 0.15 GPa and 823 K for 2 h in N2. High pressures up to 5 GPa were applied to the powder sample in the cubic/ octahedral anvil apparatus according to a technique described elsewhere.34 Briefly, the raw powder sample was packed into a BN capsule and placed at a center of the inner octahedral anvils with pyrophyllite pieces as... 

To investigate the colouring matter added,1 15-20 grams of the butter are boiled in a reflux apparatus with about 40 c.c. of methyl alcohol. When thoroughly cold (best in ice) the liquid is filtered and to the residue from a few drops of the alcoholic solution evaporated in a porcelain capsule is added drop by drop down the side of the dish, cone, sulphuric, nitric or hydrochloric acid, the colour manifested being observed. 

USP Apparatus I (basket method) preferred for capsules and dosage forms that tend to Loat or disintegrate slowly... 

In practice, the high-pressure polycondensation of the salt monomers producing polyimides was carried out by using a piston-cylinder type hot-pressing apparatus with the use of a Teflon capsule as a reaction vessel (see Eq. 5) [34]. 

B. Assemble an apparatus for Thin-Layer Chromatography (see Chromatography, Appendix IIA), using chromatographic silica gel as the adsorbent and a 4 1 mixture of cyclohex-ane ether as the solvent system. Prepare a Standard Solution by dissolving the contents of 1 capsule of USP Vitamin A Reference Standard in sufficient chloroform to make 25.0 mL. 

---