A Brief Review on Dissolution Method Development


Ashok B. Patel1, Avadhi R. Bundheliya1, Rushali V. Zala1*, Amitkumar J. Vyas1, Nilesh K. Patel1, Ajay I. Patel1, Devang B. Sheth2

1B.K. Mody Government Pharmacy College, Rajkot- 360003, Gujarat, India.

2L.M. College of Pharmacy, Ahmedabad.

*Corresponding Author E-mail: rushalizala285@gmail.com, sunnyrshsh@gmail.com



Dissolution testing is a critical methodology; widely utilized in the development of a new pharmaceutical product. The test, in its simplest form, consists of placing the formulation in a dissolution apparatus containing suitable dissolution medium. The BCS has been a predictive tool for assess the prospective effects of formulation on the human, drug oral bioavailability. When used in combination with in vitro dissolution tests, the BCS can maintain the prediction of in vivo product performance and the development. Filtration is critical in drug dissolution testing as filtration stops the dissolution process and allows for accurate quantitation through separation of dissolved and un-dissolved components. The objective of this investigation was to determine if other sinker shapes will influence the rate, extent, or variability of dissolution. Dissolution test is required to study the drug release from the dosage form and its in vivo performance. Dissolution test is used to asses the lot-to-lot quality of drug product. development and validation of dissolution procedure(s) and to provide practical approaches for determining specificity, linearity, range, accuracy, precision, LOD, LOQ and robustness of methods.


KEYWORDS: Dissolution method, Dissolution Apparatus, Validation, Paddle, Dissolution testing, Dissolution medium.




The definition of dissolution is deceptively simple. It is the process in which a solid substance goes into a solution. For dosage forms containing an active solid ingredient, the rate of dissolution may be critical to absorption. Obviously, in most instances, dissolution of the active solid material is affected by a variety of factors such as the medium in which the drug is dissolving, the temperature of the medium, and the affinity for the solid particles to dissolve in the medium.


There are numerous other factors, such as excipients, coatings, and pH, which affect the rate of dissolution. While the most rapid absorption is from a solution, most dosage forms are solids, either tablets or capsules. One must also consider dissolution from suspensions and suppositories. Several chapters in this text cover various dosage forms as the theme for the discussion on dissolution.


Theories of Dissolution: 6-8

Three Theories:

1.       Diffusion layer model / Film theory

2.       Danckwert's model / Penetration or Surface renewal theory

3.       Interfacial barrier model / Double barrier or Limited solvation theory

Diffusion layer model / Film theory:

Fick's second law of diffusion Nernst and Brunner incorporated Fick's first law of diffusion and modified the Noyes-Whitney's equation to:


dC/dt = DAK/ (C₁-C₂) ... (2)



D = diffusion coefficient of drug

A = surface area of dissolving solid

Kw/o = water/oil partition coefficient of drug

V = volume of dissolution medium

h = thickness of a stagnant layer

(C-C) = conc. gradient for the diffusion of the drug


Danckwert’s model:

Danckwert's model is expressed by the equation:


V. dC/dt= dm/dt = A (C₁-C₂). (y.D) ..........(4)



m = mass of solid dissolved

Y = rate of surface renewal


Interfacial barrier model:


G = K₁ (C₁-C₁) .........(5)



G= dissolution rate per unit area

K₁ = effective interfacial transport constant


Mechanism of Dissolution 9,10

·         Initial mechanical lag

·         Wetting of dosage form

·         Penetration of dissolution medium

·         Disintegration

·         Disaggregation

·         Dissolution

·         Occlusion of some particles


Figure 1: Mechanism of Dissolution


Dissolution Apparatus 11-13

1.       Basket Apparatus

2.       Paddle Apparatus

3.       Reciprocating cylinder

4.       Flow-through cell

5.       Paddle over disk

6.       Cylinder Apparatus


BCS Classification 14-21


Figure 2: BCS Classification


Class I

In-vivo, these drugs behave like an oral solution that has fast dissolution and fast bioavailability. Since the dissolution and absorption of class I drugs are extremely fast, bioavailability and bioequivalence are pointless for the products of such drugs. Class I drug molecules are not those in which either solubility or permeability is limited within the target regions of the GI tract.


Single-composition osmotic tablet system, Microsphere, constant surface area drug delivery shuttle, Diffusion-controlled matrix system, Delayed pulsatile hydrogel system (Dual release drug absorption system) Granulated modulating hydrogel system, Intestinal protective drug absorption system, Microparticle Drug Delivery Technology, Pelletized pulsatile delivery system, bio erodible enhanced oral drug absorption system, programmable oral drug absorption system, spheroidal oral drug absorption system, Solubility modulating hydrogel system and Stabilized pellet delivery system.


Class II

By definition, poor solubility and/or slow dissolution are the rate-limiting steps for oral absorption of BCS class II compounds.


formulations designed to overcome solubility or dissolution rate problems.

Salt formation

Particle size reduction

Metastable forms

Solid dispersion


Lipid-based formulations

Precipitation inhibitors


Class III:

Drug molecules of this class permeate the intestinal membrane from the rate-determining step for these drugs. Since absorption is permeation rate limited, bioavailability is self-governing of drug release from the dosage form. For example, the different ranitidine products having dissimilar dissolution profiles produce superimposable plasma concentration versus time profiles in vivo. This class of drugs usually has low bioavailability, and permeability enhancement is normally required. These drugs are challenging for controlled release development.


Class IV:

Drug molecules in this class show poor and unpredictable bioavailability. General bioavailability is governed by numerous factors, such as rate of dissolution, intestinal permeability, gastric emptying, and so on. These drugs are usually not suitable for oral drug delivery, or else some special drug delivery technologies such as nanosuspensions will be desirable.


Knowledge of Drug and Drug Product:22

         Characteristics of the API, e.g., particle size, crystal form, bulk density, solubility.

·         Product composition, e.g., drug loading or dose, and the identity, type, and levels of excipients.

·         Manufacturing process, e.g., compression forces equipment.

·         Effects of stability storage conditions, e.g., temperature and humidity.

·         Incompatibility of the drug with certain buffers or salts.


Dissolution Tester Choice: 22

         Paddles and baskets tend to be the choices for most solid oral dosage forms.

·         If pH changes, greater/smaller volumes, or different agitation is needed, then Apparatus 3 and 4 are often considered after exhausting Paddle and Basket testing.

·         For Transdermal Apparatus 5-7 are the primary choices.

·         For semi-solid dosage forms, the generally used apparatus includes the vertical diffusion cell. immersion cell, and flow-through cell apparatus with a tie insert for topical dosage forms.

·         A rotating bottle or dialysis tubes may have utility for microspheres and implants; peak vessels for eliminating coning; and modified flow-through cells for special dosage forms including powders and stents.


Dissolution method Development:22

Selection of Dissolution Media 23-26

Types of Dissolution Media:

1)       Simulated Gastric Fluid (SGF)

2)       Simulated Intestinal Fluid (SIG)

3)       Water

4)       Biorelevant Media


Simulated Gastric Fluid:

The traditional medium to simulate gastric conditions in the fasted state and has been simulated gastric fluid (SGF) of the USP.


This medium contains hydrochloric acid and sodium chloride, as well as pepsin and water, and has a pH of 1.2.


Although the medium addresses many of the qualities of gastric juice, some aspects could be optimized.


Simulated Intestinal Fluid:

The only parameter that has been changed is the pH of the medium.


SF is composed of Potassium Dihydrogen Phosphate and Sodium hydroxide.



Water is an attractive medium that, because of its simplicity, has been widely used for quality control purposes.


However, the pH of water may vary with its source, and water has no buffer capacity. Thus, for the latter purpose, a better alternative, which would be more relevant in this context, is a diluted HI/NaC1 solution or a diluted acetate buffer with a final pH of around 5.


Biorelevant Media:

Biorelevant media are virtually the same as intestinal juices. They contain key natural surfactants (bile salts, phospholipids) present in intestinal juices. These are missing from ordinary dissolution media.


They are virtually the same as the fluids inside the body, it can provide a much more accurate picture of how drugs and their formulations are likely to dissolve in vivo.


The aims are to highlight potential bioavailability issues and attempt to achieve IVIVC.


Biorelevant media include Fasting state and Fed state simulated Gastro Intestinal fluids.


Performing filter compatibility27

Filtration removes undissolved drugs and excipients from the withdrawn sample solution.

In an unfiltered solution, drug particles will continue to dissolve.

This will affect the results.


Important characteristics to be considered when choosing the filter material.

·         Type




Filter size should be based on

         The volume of the sample to be withdrawn

         The correct dimension of the filter will

         Improve throughput

         Improve recovery

         Reduce clogging


Different types of filters are used

         Cannula filters

         Disk Filters

         Tip Filters

         Syringe filters


Selection of Apparatus27, 28

The selection of apparatus is based on formulation design and practical aspects of dosage form performance in the in vitro test arrangement. Dissolution testing is carried out on equipment that has suitableness, such as that described in the United States Pharmacopeia (USP) under the charters of Dissolution and Drug Discharge.


Table 1: List of the official Dissolution Apparatus and their uses

Sr. No.

Apparatus Type

Apparatus Name





Tablets, capsules, Floating dosage forms




Tablets, capsules, enteric forms



Reciprocating cylinder

Extended-release drug product



Flow-through cell

Implants, powders, suspensions



Paddle over disc

TDDS, Ointments







Reciprocating holder

Extended-release drug product


Agitation speed 29


Table 2: USP Apparatus and Agitation criteria

USP Apparatus


Rotation Speed

Dosage Form



50-120 rpm




25-50 rpm



Reciprocating cylinder

6-35 rpm



Flow-through cell




Paddle over disc

25-50 rpm







Reciprocating holder

30 rpm



Sinkers 30


Figure 3: Types of Sinkers


Sinker shapes:

Longitudinal, lateral, screen enclosures, and internal weights.


Selecting a Sinker:

Selecting the correct sinker for your application can require some trial and error. However, there are some guidelines to follow to help with this process. Some important factors need to be taken into consideration.


Sinker Size:

Size and dimension are important. The sinker should have minimal surface contact with the tablet, as this can affect the dissolution rate. Some dosage forms swell, and the sinker must take account of this if required. It should be easy to put the dosage form in the sinker without scratching the surface.


Sinker Material

The majority of sinkers are made from 316 stainless steel and are resistant to water or standard dissolution media. PTFE Coated Sinkers can be used with magnetic retrieval systems, or where there may be a reaction or adsorption between steel and the tablet. These tend to have a shorter lifetime as once the surface is scratched the iron inside will quickly corrode. Plastic coated “3 prongs” sinkers can also be used although this style will have direct contact with the tablet which is not necessarily desirable.


Sinker Weight:

In general, the sinker should be heavy enough to sink the dosage form to the bottom of the vessel. Heavier than that would suggest more wire than is necessary with the associated possible flow effects. For spiral sinkers, this means the fewest number of spirals required to sink the dosage form but enough the prevent it from coming out of the wire when wet.


Capsules tend to be very buoyant because of their air content, but once the outer surface has dissolved, the micro-spheres inside can then move freely.

Special Sinkers:

Special sinkers are also available for immediate release dosage forms and films. For 'coin' shaped dosage forms a circular basket sinker may be used. Similar sinkers can be used for some micro-sphere or powder applications.


Deration: 27, 31

The significance of deaeration of the dissolution medium should be determined because air bubbles can act as a barrier to the dissolution process if present on the dosage unit or basket mesh and can adversely affect the reliability of the test results.


Typical steps for deaeration include

         Heating the medium

         Filtering, and drawing a vacuum for a short period of time

         Other methods of deaeration are available and are in routine use throughout the industry.

         The extent of deaeration can be evaluated by measuring

         The total dissolved gas pressure

         The concentration of dissolved oxygen in the water


Q Point 13, 32

USP defines Q as the quantity or the "amount of dissolved Active Pharmaceutical Ingredient (API) specified in an individual monograph, expressed as a percentage of the labeled content of the dosage unit...".


Table 3: immediate-release acceptance criteria


Number Tested

Acceptance criteria



Each unit is not less than 5%.



The average of 12 units (S1+5₂) is equal to or greater than Q, and no unit is less than Q-15%.



The average of 24 units (S₁ +5₂ +5₁) is equal to or greater than Q, not more than 2 units are less than Q- 15% and no unit is less than Q 25%.


Enzyme 22, 33

Pepsin is an enzyme commonly used in dissolution media, and in this work, the activity of pepsin was determined in the presence of different surfactants as usually found in the case of dissolution tests of certain gelatin capsule formulations.


Pepsin is the enzyme commonly used in acidic dissolution media (pH 1 to pH 4) to break peptide bonds in gelatin capsules that are affected by cross-linking. Pepsin is a monomeric, two-domain, mainly l-protein, with a high percentage of acid residues (43 out of 327) leading to its very low isoelectric point.


Study Design 27, 34

Time point



Time point

For immediate-release dosage forms,

         The f2 similarity factor is not necessary when more than 85% is dissolved at 15 min.

         If the f2 similarity factor is to be used

·         Multiple time points for the dissolution test are required,

·         At least two-time points below 85% dissolved and

·         Only one point above 85% for both products

·         The addition of 5-, 10-, 15-, or 20-min time points, therefore, may be useful.

For testing an extended-release dosage form,

·         At least three-time points are chosen,

·         To guard against dose dumping,

·         To define the in vitro release profile, and

·         To show that essentially complete release (>80%) of the drug is achieved.

·         Additional sampling times may be useful.



visual observation, proper lighting (with appropriate consideration of photo-degradation) of the vessel contents and clear visibility in the bath are essential.


Documenting observations by drawing sketches and taking photographs or videos can be instructive and helpful for those who are not able to observe the real-time dissolution test.


Observations are especially useful during method development and formulation optimization. It is important to record observations of all six vessels to determine if the observation is seen in all six vessels, or just a few.


If the test is performed to assist with formulation development, provide any unique observations to the formulator.




Manual sampling uses plastic or glass syringes, a stainless-steel cannula that is usually curved to allow for vessel sampling, a filter, and/or a filter holder. The sampling site must conform to specifications under Dissolution (711).


Auto sampling:

Auto sampling is a useful alternative to manual sampling, especially if the test includes several time points. However, because regulatory labs may perform the dissolution test using manual sampling, auto sampling requires validation with manual sampling.


How to Handle Sample? 22

Always handle dosage units. with gloves (not cotton), forceps, or tweezers that will not scratch or damage the surface of the dosage unit.


Examine the six dosage units.

Do not use chipped, cracked, or capped tablets.


Weighing of the sample? 22

Option: Record the dosage unit weights?

Weight information is for and investigation purposes only.

Dosage units are to be chosen at random and may not be selected. discarded based on weight.


Dissolution Procedure validation: 28-36


According to FDA, Validation is establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.


According to EU guidelines, Validation means the action of proving, following GMP principles that any procedure, process, equipment, material, activity, or system leads to the expected results.


Specificity/ Placebo Interference:


It is necessary to demonstrate that the results are not unduly affected by dissolution medium blank, (USP 1-Dec-2020) placebo constituents, other active drug substances, (USP 1-Dec-2020), or potential degradation products from the dissolved drug substance in the dissolution medium.



The placebo consists of all the excipients and coatings, with inks and capsule shells included if appropriate, without the drug substance. (USP 1-Dec-2020)

Placebo interference can be evaluated by using a spiked placebo that is prepared by weighing samples of the placebo blend, dissolving or dispersing them in dissolution medium at concentrations that would be encountered during testing, and adding a known amount of the drug in solution.

It may be preferable to perform this experiment at 37°, comparing the solution to a standard solution at the concentration expected to be encountered during testing, by using the formula:

Result = (AP/AS) × CS × (V/L) × 100


AP = absorbance or response of the placebo

AS = absorbance or response (USP 1-Dec-2020) of the standard

CS = concentration of the standard (mg/mL)

V = volume of the medium (mL)

L = label claim (mg)

The blank is the dissolution medium without the dissolved sample, and it is treated in the same manner as the sample. The effect of the absorbance of the blank at the analytical wavelength should be evaluated.


Linearity and range:


Linearity is the ability (within a specified range) to obtain test results that are directly proportional to the concentration of analyte in the sample. … ICH recommends that for dissolution testing, linearity should be demonstrated as ± 20% over the range of the dissolution test.



Linearity is typically established by preparing solutions of the drug substance, ranging in concentration from less than the lowest expected concentration to more than the highest concentration during release. The solutions may be prepared either using 1) a standard solution or spiked solution or 2) by the method of standard addition. A minimum of five concentrations is normally used (see á1225ñ). Typically, solutions are made from a common stock if possible. The concentration range may not exceed the linearity limits of the method, Organic solvents may be used to enhance drug solubility for the preparation of the linearity standard solutions. However, NMT 5% (v/v) of organic solvent should be present in the final solution unless validated. Linearity is typically calculated by using an appropriate least-squares regression program. The range of the procedure is the interval between the upper and lower concentrations of the drug substance.


Accuracy and Recovery:


Accuracy expresses the closeness of agreement between the values which are accepted either as a conventional true value or an accepted reference value and the value found practically.


Accuracy is measured by

(1) Use of reference standard with known purity

(2) Comparison with independent



Individual solutions may be directly prepared in the dissolution medium. Alternatively, to enhance drug solubility it may be appropriate to prepare a stock solution by dissolving the drug substance typically (USP 1-Dec-2020) in a small number of organic solvents and diluting to the final concentration with dissolution medium. The amount of organic solvent should not exceed 5% in the sample solution. An amount of stock solution equivalent to the targeted label claim may be used instead of the drug substance powder. Similarly, for very low strengths, it may be more appropriate to prepare a stock solution than to attempt to weigh very small amounts. The measured recovery is typically 95%–105% of the amount added. Bracketing or a matrix of multiple strengths may be useful.



It is defined as the closeness of agreement (‘scatter’) between a series of measurements obtained from multiple sampling of the same homogeneous sample.

 The aspects for precision are

(1) Repeatability

(2) Intermediate precision

(3) Reproducibility


Precision – Repeatability:

Repeatability expresses the precision under the same operating conditions over a short interval of time. Repeatability is also termed intra-assay precision. Repeatability is sometimes also termed within-run or within-day precision.


Precision - Intermediate precision:

Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc. The ISO definition used the term "M-factor different intermediate precision", where the M-factor expresses the number of factors (operator, equipment, or time) that differ between successive determinations. Intermediate precision is sometimes also called between-run, between-day, or inter-assay precision.


Precision – Reproducibility:

Reproducibility expresses the precision between laboratories (collaborative studies, usually applied to standardization of methodology). Reproducibility only has to be studied, if a method is supposed to be used in different laboratories.


For dissolution method validation purposes, precision is measured over two levels, repeatability and intermediate precision. Repeatability refers to the application of the procedure within one laboratory over a short period of time by one analyst using one instrument. Repeatability is determined by replicate measurements of standard and/or sample solution.




The quality of being strong, and healthy or unlikely to break or fail.



The robustness of an analytical procedure is the measure of its capacity to remain unaffected by small deliberate variations in parameters internal to the procedure (USP 32-NF 27, 2009; ICH guideline, 2005). For dissolution testing, parameter to be varied includes medium composition, pH, volume, agitation rate, and temperature.



It is a measure of method reproducibility under variable conditions within specified test parameters of the test method.


The following are the typical method parameters that need to be tested during method validation

Analyst-to-Analyst variability.

Column-to-Column variability.

System-to-System variability.

Different days.

Different Laboratories.

Stability of Solutions and mobile phase. (At least for 48 hours)


Limit of Quantitation:

It is defined as the lowest amount of an analyte in a sample which can be quantitatively determined with suitable precision and accuracy.


Limit of Detection:

It is defined as the lowest amount of an analyte in a sample that can be detected but not necessarily quantitated. Detection methods like visual evaluation, signal-to-noise ratio (3:1), and standard deviation (SD) of response and slope.



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Received on 16.02.2022       Modified on 08.03.2022

Accepted on 05.04.2022   ©Asian Pharma Press All Right Reserved

Asian J. Pharm. Ana. 2022; 12(2):127-134.

DOI: 10.52711/2231-5675.2022.00023