PRACTICAL 3 : PRACTICAL ASSESSMENT OF QUALITY OF TABLETS AND CAPSULES (1)

PRACTICAL 3: ASSESSMENT OF QUALITY OF TABLETS AND CAPSULES

INTRODUCTION

            Quality control is an essential operation of the pharmaceutical industry. A drug must be proven safe and therapeutically active before marketed. The performance of the drug formulation is tested during the assessment of drugs to ensure its consistency. Like all the other dosage forms, tablets and capsules are subjected to those pharmacopoeia standards which deal with “added substances” with respect to their toxicity, interference with analytical methods, etc. There are several procedures which apply specifically to tablets and capsules to examine the quality of the formulation. These procedures not only ensure the effectiveness of the pharmacological actions, but also to determine the uniformity of the physical properties of the official tablet/capsule, irrespective of the manufacturer.

            The testing specifications established for tablets include physical, chemical and biological tests. Physical testing specifications can comprise of size, shape, colour, friability, breaking force or hardness, and disintegration. Inspecting the appearance of a tablet can be a quick quality check. Such standards are found in the British Pharmacopoeia and United Pharmacopoeia which are uniformity of diameter, uniformity of weight, content of active ingredient, uniformity of content, friability, disintegration and dissolution. Besides, there are some quality control procedures which are widely used but not defined by the pharmacopoeias such as thickness and hardness.

Experiment 1: Physical Appearance

1.      A type of tablet or capsule is selected from the provided samples. The shape, colour, diameter, thickness and other physical characteristics are examined and noted.

Characteristics	Tablet	Capsule
Shape	Round	Cylindrical with hemispherical ends
Colour	Pink	Yellow & blue
Diameter	1.8cm	0.7cm
Thickness	0.5cm	0.7cm
Coating	Yes	-
Wording	APP 250	MEFA

DISCUSSION:

            Size and shape of tablets and capsules may directly affect a patient’s ability to swallow a particular drug product. These factors also affect the transit of the product through the pharynx and esophagus. Larger tablets and capsules will be difficult to pass through the esophagus thus have a prolonged esophageal transit time. This can lead to disintegration of the product in the esophagus and/or cause injury to the esophagus, resulting in pain and localized esophagitis and the potential for serious sequelae. Other adverse events such as pain, choking, and aspiration are related to swallowing difficulties. These undesired effects increasingly occur at larger tablet and capsule sizes.

            In vitro studies suggest that flat tablets have greater adherence to the esophagus than capsule-shaped tablets. Studies in humans have also suggested that oval tablets may be easier to swallow and have faster oesophageal transit times than round tablets of the same weight. Patient compliance with medication regimens may be influenced by the size and shape of a tablet or capsule.

            The presence and composition of a coating can also potentially affect the ease of swallowing tablets or capsules. The lack of a film coating can decrease or prevent tablet mobility compared with a coated tablet of the same size and shape. Coating also can affect other factors that contribute to patient acceptance, such as palatability and smell. The wording printed on the tablets or capsules is primarily for recognition purpose.