INTRODUCTION

The dissolution apparatus (ELECTROLAB tdt-08l) is a microcontroller based 8 station dissolution testing
system which confirms to USP, IP and EUR pharmacopoeia specifications. This instrument supports USP
1,2,5,6 and intrinsic dissolution methods. Unit has been designed for user friendly operation and supports a
menu driven 20×4 character backlit LCD display. The tdt-08l is provided with a microcontroller based stepper
motor drive which give precise rpm. The water bath is attached to an isolated water circulating pump with a
temperature controller to ensure a uniform set temperature in water bath. The pump is isolated from the water
bath to eliminate vibration. The water bath is moulded to prevent leakage and shaped for easy cleaning to
comply with GLP. it is provided with quick release coupling for ease of operation.[2]

PRINCIPLE
The dissolution tester TDT-08L works on dissolution. Dissolution is defines as the process by which solid
solute enters into solution when added to an appropriate solvent. Dissolution rate is defined as the amount of
solid substance that goes into solution per unit time under standard conditions of temperature, pH and
solvent composition and constant solid surface area. Dissolution rate refers to the rate at which the solid
dissolves in a solvent. When a solid dosage form such as a tablet is introduced into the water, the drug
contained in the tablet begins to pass into solution. Simultaneously, the solid matrix of the tablet
disintegrates into granules and these granules in turn deaggregate into particles. Dissolution of drug takes
both from the disintegrated granules and form the fine particles shown in figure 2.[1]

Dissolution, Disintegration and Deaggregation steps involved in the release of drug from a tablet.

CLASSIFIATION

The USP dissolution tester is classified as the following types:

1. Rotating basket 2. paddle 3. reciprocating cylinder

4. flow through cell 5. paddle over disc 6. rotating cylinder

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7. reciprocating holder

* In this practice school’s equipment profile USP dissolution apparatus 2 (paddle apparatus) is discussed.

CONSTRUCTION

The assembly (paddle apparatus) consist of the following: a covered vessel made of glass or other inert
glass or other inert, transparent material; a motor; a metallic drive shaft; a paddle; formed from a blade
and shaft is used as the stirring element. the shaft is positioned so that its axis is not more than 2 mm at
any point from the vertical axis of the vessel and rotates smoothly without significant wobble. the vertical
centre line of the blade passes through the axis of the shaft so that the bottom of the blade is flush with the
bottom of the shaft. The paddle confirms to the specification shown in the figure 3. The distance of 25 +_
2 mm between the blade and the inside bottom of the vessel is maintained during the test. The metallic or
suitably inert, rigid blade and shaft comprises a single entity that may be coated with a suitable inert
coating. The dosage unit is allowed to sink to the bottom of the vessel before rotation of the blade is
started. A small, loose piece of nonreactive material such as not more than a few turns of wire helix may
be attached to the dosage unit that would otherwise float. Other validated sinker devices may be used.[3]

Figure 3 – paddle stirring element.

WORKING

The paddle apparatus (Apparatus 2) consists of a special, coated paddle that minimizes turbulence due to
stirring. The paddle is attached vertically to a variable-speed motor that rotates at a controlled speed (25-
50). The tablet or capsule is placed into the round-bottom dissolution flask, which minimizes turbulence
of the dissolution medium. The apparatus is housed in a constant-temperature water hall maintained at 37°
C. The position and alignment of the paddle are specified in the USP. The paddle method is very sensitive
to tilting. Improper alignment may drastically affect the dissolution results with some drug products. The
same set of dissolution calibration standards is used to check the equipment before tests are run. The most
common operating speed for Apparatus 2 are 50 rpm for solid oral dosage forms and 25 rpm for
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suspensions. Apparatus 2 is generally preferred for tablets. A sinker, such as a few turns of platinum wire.
may be used to prevent a capsule or tablet from floating. A sinker may also be used for film coated tablets
that stick to the vessel walls or help position the tablet or capsule under the paddle. The sinker should not
alter the dissolution characteristics of the dosage form.[4]

USES

1. It is the rate limiting factor for poorly soluble drugs.

2. Estimation of amount of drug released per unit time.

3. Batch to batch quality control.

4. For product development.

APPLICATIONS

1. The dissolution test is used as a quality control tool to monitor routinely the uniformity and
reproducibility of production batches. In this case, a single point determination, i.e. a certain percentage
of the drug dissolve in a fixed time period, is usually a sufficient quality control parameter.

2. The dissolution test is utilize as a research tool for optimizing the parameters and ingredients in new
formulations.

3. In pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug
release information for both quality control purpose, i.e. to assess batch to batch consistency of solid oral
dosage forms such as tablets, and drug development, i.e. to predict in vivo drug release profiles.[5]

8. VARIENTS (Available in market)

1. ELECTROLAB DISSOLUTION TESTER (USP)

Company – ELECTROLAB Pvt. Ltd. India. Model no. – EDT-08Lx

Figure 4 – (ELECTROLAB dissolution tester)

2. ERWEKA DISSOLUTION TESTER

Company - ERWEKA Asia Pacific Ltd. (Model – DT 720)

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Figure 5 – (ERWEKA dissolution tester)

REFERENCES

[1] Aggarwal SP, Khanna R. Physical pharmacy, Second edition; 2006. CBS publishers and distributors,
New Delhi. P. 297.

[2] Rai T. Aug 21, 2011. Available from: [https://www.scribed.com/doc/62744813/TDT-08L]

[3] US Pharmacopeia 24, NF19. United state pharmacopeial convention, INC 1999. Asian edition. P. 1942.

[4]Shah M. 24 mar 2011. Available from: [http://www.pharmatips.in/Articles/Pharmaceutics/Tablet/Drug-

Dissolution-Apparatus-II-USP-Paddle.aspx#:~:text=The%20paddle%20apparatus%20]

[5] Subrahmanyam CVS. Textbook of Physical pharmaceutics, second edition; 2000. Vallabh prakashan,
NEW Delhi. P. 86.