A REVIEW OF DIFFERENT DISSOLUTION METHODS

A REVIEW OF DIFFERENT DISSOLUTION METHODS

R. Thirumalaikumaran *, G. Lithikkaa and K. A. Kailash

Saveetha College of Pharmacy, Saveetha Institute of Medical and Technical Sciences (DU), Chennai, Tamil Nadu, India.

ABSTRACT: Dissolution is an authorized test used by Pharmacopoeias for assessing drug arrival of solid and semisolid measurement structures. The primary utilization of dissolution testing incorporates the biopharmaceutical portrayal of medication items as a device to guarantee reliable item quality and to predict in-vivo drug bioavailability. Dissolution testing was initially grown for solid orals; later on, its utilization was enlarged to an assortment of novel dose structures. Because of the intricacies in the medication conveyance of novel dose structures, there is a need to create changed dissolution testing strategies to describe the in-vitro arrival of these measurement structures. The article addresses the ongoing updates in dissolution testing strategies for ordinary and novel drug measurement structures and gives knowledge of potential choices in drug dissolution testing plans. This survey addresses all potential state-sanctioned test techniques expected to describe the dissolution properties of a wide assortment of measurement structures going from customary to novel conveyance.

Keywords: Dissolution, Factors affecting dissolution, Dissolution apparatus, Dissolution testing

INTRODUCTION: Physical chemists have been researching dissolving processes since the late 19th century. As a result, the majority of fundamental research in this area has little to do with pharmaceuticals, and by the time the field of intriguing drug dissolution started to develop, basic laws characterizing the dissolving process already existed ¹. One of the most helpful tests is the dissolution profile test. Drug development, stability studies, compatibility evaluations, routines scale, and change following quality control and approval are only a few methods utilized at different stages of the drug product lifecycle.

This test is appropriate for various dose forms, including suppositories, gums, chewable tablets, powders, vaginal inserts, implants, transdermal absorbers, suspensions, etc. for internal use and injection ². Drug absorption from oral administration depends on intestinal permeability and drug dissolution in the gastrointestinal tract (GIT) fluid. The arrangement is reached through a cycle that yields solids with only reasonable dissolving characteristics.

"Recording from substance going through liquids with homogeneous course of action" is how it is described. The dissolution test is one of the most frequently used tests for dosage form quality control. When resolution matters, a rate-limiting phase in medication absorption, this testing is very crucial. It is the rate-limiting step for hydrophobic medicines (phenytoin, griseofulvin, and spironolactone). As a result, the drug candidates' poor lipid and water solubility commonly hinders the creation of multiple oral dosage forms. These candidates are expensive, lipophilic, and barely soluble in water. Studies on absorption in-vitro, in-situ, and in-vivo primarily result from this poor dissolving behavior ³. The examination of drug release from solid and semisolid formulations to the application form is done using a test called dissolution. This test measures the pace and volume of medication release from a dose form. Different mathematical formulae can be used to quantitatively analyze values from dissolving tests ⁴.

For example, minor formulation changes or manufacturing site changes can impact performance. In-vitro dissolution testing is crucial for process control and quality assurance, determining long-term product stability and release profiles, and facilitating specific regulatory requirements ⁵. It is employed in the pharmaceutical industry to guarantee dissolution, to guarantee appropriate in vivo performance, and to validate that each batch meets product criteria for the duration of the dosage form as a whole. The dissolving check is used to ensure our product is of pharmaceutical quality. Produce items in a repeatable manner such that they maintain their release properties throughout their shelf life. Therefore, creating a dissolution test would be advantageous. Examine the dosage forms' capacity for drug release to get a full and simultaneous picture of how your product will appear and function in-vivo. Dissolution is mostly a result of biopharmaceutical cooperation and quality control testing ³.

Objectives of Dissolution: Typical methods employed when creating solution carriers for medicines that are not readily soluble include:

1. Increasing the volumetric or removal of aqueous sinks medicine to induce drug solubility.
2. Drug co-solvent Solubilization with up to 40% addition of anionic and non-anionic surfactants for post-micelle concentration.
3. Alter the pH to make an insoluble medicinal molecule more soluble.

Drugs with low water solubility are frequently recommended as solutions in the form of surfactant solutions. Aqueous solutions of such surfactant simulate the physiological environment more accurately than using sorbents or hydro alcohols, aliphatic media ⁶.

History of Dissolution: The first dissolving studies are discussed in the literature. They discovered how lead chloride and benzoic acid, two sparingly soluble chemicals, dissolved in 1897, thanks to Noyes and Whitney. He chose to assume rate limiting in 1951 when deciding how to absorb aspirin into the bloodstream. Nelson was the first scientist to specifically administer theophylline orally for its dissolution in 1957, referring to blood levels. However, the therapeutic benefit of oral administration of these drugs began to dissolve in the middle of the 1960s. A 7-fold variation in serum digoxin levels was noted in 1971 Lindenbaum ⁷.

TABLE 1: MAJOR CONTRIBUTIONS AND EVENTS IN THE DEVELOPMENT OF DISSOLUTION TESTING ⁸

Many Mathematical Concepts: The justification comes from the modified Noyes-Whitney equation. Justification for describing how particles dissolve:

𝑑𝑚 / dt = 𝐴𝐷𝐶𝑆−𝐶/ h

Dissolved, D is the molecular diffusion coefficient, cs is the solubility in the medium, and h is the thickness of the diffusion boundary layer that is close to the melt surface connection. This straightforward mass balance equation leads us to the following conclusions: dm/dt can be enhanced to increase the dissolution rate; micronized and/or optimized wetting qualities to promote perfect submersion; the condition to minimize the boundary layer thickness (C+0); or by raising the apparent drug solubility Cs. Parameters The solute molecules' diffusion coefficient determines D. When C=0, the maximum dissolution rate is anticipated. Therefore, increasing C causes the disintegration rate to decrease. As a result, raising C lowers the dissolution rate, or parameter D, which Cs-C also influences. In an environment like in-vivo, the medicine dissolves and is then absorbed. The condition is known as the sink state. With a novel solvent that doesn't build up solutes active material in the dissolution medium, the perfect in vitro system preserves subsidence and dissolved solids testing. With the help of a flow-through type device, such a circumstance is simply a reality. For instance, USP apparatus 4 gradually increases C for apparatuses 1 and 2 ⁸.

Physical and Chemical Properties: The initiative dissolution is the physical and physical rating of chemical information on drug content. Knowledge of this information will help you choose a dissolution medium and its amount. Several physic-chemical properties of the API to determine the dissolution properties are:

• Ionization constant (PKA),
• Solubility as a function of PH,
• Solution stability as a function of PH,
• Particle size,
• Crystal shape,
• Common ion, ionic strength, and buffer effect, •Temperature, •Stirring.

The selection of appropriate dissolution media and devices can be determined based on the physicochemical properties of the drug substance and dosage form. Determining the dosage form’s release mode and expected in-vivo absorption sites will help select dissolution media, test apparatus, and testing duration ⁹.

Conditions: Temperature - 37 ± 0.5℃ pH - ±0.05 units in the reference, Capacity - 1000ml. Distance from the inside of the container paddles/baskets is kept at 25±2 mm. Enteric, the coated dosage form is first dissolved in 0.1N HCL and then dissolved in buffer pH 6.8 for measuring drug release. Limit - NMT 10% the drug should dissolve in the acid after about 2 hours 75% of this should be dissolved in the buffer after 45 min ¹⁰.

Factors Affecting Dissolution Rate:

1. Physico-chemical properties of drugs
2. Formulation factors
3. Processing factors
4. Factors related to melting equipment
5. Factors connected with dissolution test boundaries ¹¹.

Selection of Dissolution Apparatus: Device selection is based on dosage form in formulation design and in-vitro testing configuration. There are many different types of apparatus are; Solid dosage form (tablet and capsule): I.P. and E.P:

Apparaus 1: Paddle type

Apparatus 2: Basket type

1. P and U. S. P:

Apparaus-1: Paddle type Apparatus -2: Basket Type B.P. and E.P:

Apparatus 3- Flow through cell apparatus. [10]

There are 7 sorts of USP Mechanical Assembly: Type 1 USP Apparatus: Basket Apparatus

1. Dosage forms included in the basket.
2. Dissolution must be done in the basket.
3. Changes in pH due to medium change.

Application: tablet, capsules, beads, floaters.

Type 2 USP Apparatus: Paddle Apparatus

1. Dosage form should remain center-bottom of vessels
2. Sinkers for floater
3. pH change by addition of medium.

Application: Tablets, capsules.

Type 3 USP Apparatus: Reciprocating Cylinder

Speed 6-35rpm

Application: Tablets, beads, controlled release, pharmaceutical formulation.

Type 4 USP Apparatus: Flow-Through Cell Apparatus.

Application: Drug with low solubility, rapid degradation, media pH change TYPE 5 USP Apparatus: Paddle over Disk

Rotation speed 25-50rpm

Application: Transdermal patch, ointment, floater, emulsion, bolus TYPE 6 USP Apparatus: Cylinder Apparatus

Application: Transdermal patch

TYPE 7 USP Apparatus: Reciprocating Holder

Rotations 30rpm

Application: Transdermal patch, fixed-dose shape, pH profile, low volume. USP Apparatus 4 and Apparatus 7 and their amendments and the official device show great potential, In-vitro release values for new dosage forms ¹².

TABLE 2: USP EQUIPMENT AND AGITATION CRITERIA BASED ON DOSAGE FORM TYPE ⁹

Different Dissolution Testing Devices: The USP has 7 unique devices that can be utilized for dissolution testing.

USP apparatus 1: (Basket apparatus). It is commonly called a rotating basket because it spins smoothly, and its speed meets USP recommendation. Consists of a cylindrical basket (maximum capacity 1000ml) held by a motor shaft (stainless steel); the shape is hemispherical concerning the motor rotating at a set speed.

The sample placed in the basket of a round-bottomed flask filled with dissolution medium rotating at a maximum of 100rpm. Submerge the entire flask in a constant temperature bath at 37℃. Apparatus-1 is generally suitable for capsules, suppositories, and floating or slow disintegrating ¹³. The orchestrated (1-3) basket apparatus (apparatus 1) is the most generally utilized dissolution device; user can perform dissolution tests while floating pharmaceutical preparations that do not need to be used counter sink. The basket uses the same equipment hull form as a paddle device; usually, the container has a capacity of 1L, but instead a paddle, a cylindrical basket with an opening in the mesh that holds it dosage form. Insufficient mixing at low speed, blockage “sieve effect” by mesh and mesh particles of different sizes can cause variations between dissolution results. Related fluid mechanics in the melting process using a basket device CFD and UPE were studied.

Comparison velocity obtained using UPE in recorded results a faster value for UPE was found using CFD. This is most likely due to the CFD simulated flow where the fields are time-averaged solutions and UPE methods. Get maximum value at a specific point ship level. No UPE measurements performed inside or near the basket itself where the highest speed occur differences from generated and simulated the measured speed of the investigation aircraft was low less than 10% of the maximum speed simulated at a basket device. Nonetheless, within the observed range the flow field has several time-dependent features as a result, the observed speed increase compared to the CFD simulation.

The highest speed occurs because the basket itself acts as an agitator. As suggested in the CFD, it is a simulation and may change over time action in the area of the sided of the basket. Other areas of the basket device are especially slow at medium speed in the basket and upper and lower (base) areas of vessels ¹⁴. This device is useful for tablets, capsules, pellets etc. Floater strong (for the most part drifting), monodisperse (tablets) and polydisperse (typified globules) details normally tried in USP apparatus 1. The gadget shown by Levy and Hayes can be viewed as the herald of the basket method. This consists of a 400ml beaker and a 3 blade, centrally placed polyethylene stirrer (5cm diameter) that rotates at 59 degrees rpm in 250ml of dissolution solution (0.1N HCL). Then put the tablets in favor of the measuring beaker and tests were taken occasionally ¹². Standard volume: 900/1000ml.

Benefits:

1. Over 200 monographs.
2. Full PH change during the test.
3. Easy to automate and important for investigation Burdens.
4. Decay-dissolution interaction.
5. A hydrodynamic dead Zone under the crate.
6. Degassing is especially significant.
7. Restricted volumes sink condition for ineffectively solvent drugs ¹⁵.

USP Apparatus 2: (Paddle apparatus).

The dissolution profiles of Metoprolol tablets, Acyclovir tablets, and Ranitidine HCL tablets were concentrated on utilizing USP device 2, in 900ml of disintegration media at pivot of 50 rpm, with a consistent temperature shower at 37 ± 0.5℃. The dissolution media were 0.1N HCL for Metoprolol tablets, cleansed water for ranitidine tablets, 0.1N HCL for acyclovir tablets, and pH 5.8 cradle for furosemide tablets. Four-milliliter tests drawn at 5, 10, 15, 30, 45 and an hour and recharge with 4ml of new dissolution medium. This test shifted with a 0.45µm nylon channel before investigation ¹⁶.

The paddle technique is around 70% of the dissolution strategies utilized by FDA-supported business drug items. This technique doesn’t utilize a mesh container to contain the cases, thus a typical beginning issue saw in this technique is the drifting of the SGCs to the outer layer of the dissolution medium once it breaks. In these examples, wire curls, or sinkers, can encase the delicate gels and hold them on the lower part of the vessel. This permits the fill to be better presented to the medium (upon shell burst) and assists with keeping the case from adhering to the vessel walls. The shape and size of the sinker ought to be chosen cautiously as it can influence the dissolution cycle, particularly in situations where SGCs expand when they experience the disintegration medium.

A past review showed that the dissolution rate acquired utilizing the paddle technique was quicker, exceptionally factor at lower time focuses than gotten utilizing the paddle technique was quicker, exceptionally factor at lower time focuses than those gotten utilizing the bin. Conversely, the information gathered utilizing the bin dissolution contraption showed that the technique was more specific and had less variety regarding programming interface discharge profile. Show instances of SGCs that are financially accessible also, their dissolution strategies.

Other exploration bunches have assessed the possibility of utilizing the USP 3 in assessing the dissolution of SGCs. Monterroza and Ponce De Leon fostered a segregating dissolution technique for SGCs containing a slick suspension of micronized progesterone. They analyzed the dissolution profiles produced utilizing USP 1, 2, 3. After fundamental tests, USP 1 and 2 techniques didn’t arrive at the objective of delivering over 85% of the programming interface in under 90 min. in any case, USP 3 showed a promising prospect of delivering over 85% of the programming interface in under 90min within the sight of 250ml of 4% of SLS in PH 6.8 phosphate ¹⁷. Standard volume: 900/1000ml.

Benefits:

1. Simple to utilize
2. Can be effectively adjusted to device 5
3. pH change conceivable
4. It can be effectively computerized, which is significant for scheduled examinations.

Burdens:

1. pH /media change is frequently troublesome
2. Hydrodynamics are mind-boggling; they shift with a site of the dose structure in the vessel (staying, drifting) and consequently may altogether influence drug disintegration.
3. Coning ¹⁵.

USP Apparatus 3 (reciprocal cylinder).

The fundamental parts of the responding chamber contraption are inward chambers, outside chambers, metallic fomentation bars, and the heating bath. Every unit of the measurement structure is embedded into an inward chamber, comprising a glass tube shut at the two finishes with plastic covers containing a screen made of nylon or tempered steel. The inward chambers are coupled to metallic bars that embrace the drenching and emersion developments (responding activity) inside the disintegration vessel, known as the outer chamber. This vessel is totally different from the one utilized for the basket and paddle strategies since, other than its distinctive cylindrical format and flat bottoms, it has a limit of just 300 ml.

Other than the standard 300 ml vessels, different vessels for explicit applications are additionally accessible, with 100 ml and 1000 ml limits. During the measure, an enemy of the dissipation framework is sent over the vessels to avoid modifications in the disintegration medium's volumes. The heating bath contains disintegration vessels organized in lines at 37℃. Every flat line comprises 7 vessels, 6 for the item, and the seventh might be utilized for the norm arrangement in frameworks in which the evaluation stage is mechanized or even to contain the substitution medium when this method is taken on after the assortment of tests.

In proportional development, the inside chambers stay in each line of vessels for premodified times and forces in the gadget. During emersion, the tumult framework rises until the screen in the lower cover contracts the measurement structure, which isolates from the screen and floats uninhibitedly in the disintegration medium while the mixing framework enacts. After the modified period, the poles ascend until the interior chambers are situated over the vessels, where they stay for a pre-laid-out time span so that the disintegration medium can be depleted. Then, the bars move to the following line, lowering once more, and the responding activities start again. The framework contains six lines of vessels, yet on the off chance that a bigger volume of disintegration medium is important to guarantee sink conditions, it could be modified so that, later the chambers move along the 6^th line, they return to the to start with, where the medium should be supplanted. The time the interior chambers stay in each line of vessels as well as the pH, the structure, ionic strength also, tumult speed of the disintegration medium might be chosen, as per physiological circumstances and appropriately, it is feasible to reenact the entry of the item through the gastrointestinal (GI) parcel. Tests are gathered all through the test all together to measure the medication delivered and the disintegration profiles are followed in the wake of computing the aggregate level of drug broken up. In this manner, how much medication let out of the measurement structure toward the finish of the test will relate to the rates measured in every one of the vessels covered ¹⁸. Standard volume: 200- 250ml/station.

Benefits:

1. Customized for disintegration in different media for different time
2. The media can be changed effectively
3. May begin at pH 1 and afterward pH 4.5 and afterward at pH 6.8
4. Endeavors to reflect pH changes and travel times in the GI plot.

Burdens:

1. Crumbling measurement structures show as well low outcomes
2. Surfactants causes frothing and
3. Volume of disintegration media is excessively little ¹².

USP Apparatus 4 (Flow-through cell apparatus).

Flow-through cell (apparatus 4) furnished with tablet cells of 12 mm, a ruby dab of 5mm breadth and glass globules of 1mm measurement were set in the summit of the flow-through cell to guarantee laminar progression of the 250ml of disintegration medium, recently de aerated by ultrasonic waves, going into the cell with a stream pace of 8ml min−1 ¹⁹. Sink conditions have been kept up with utilizing elective disarrangement frameworks like the USP apparatus 4 (flow-through cell apparatus). Momentarily, this framework includes a supply containing disintegration medium and a peristaltic or throbbing cylinder siphon used to drive the medium through an in upward direction positioned, temperature-controlled stream cell. Utilizing this apparatus, head servant and Bateman had the option to foster a standard test for an antimalarial plan containing two actives, atovaquone and Proguanil hydrochloride, with especially different solubilities. Disintegration utilizing the USP 2 paddle method was demonstrated to be poor, with just 40% atovaquone being delivered in 0.1m sodium hydroxide after 45 min. The restricted discharge rate was viewed because of proguanil hydrochloride, which uniquely diminished the solubility of atovaquone in sodium hydroxide.

In their study, butler and bateman changed the disintegration medium from water to 0.1m sodium hydroxide at a predefined time, in the way permitting Proguanil hydrochloride to break up at first and consequently eliminating the sink-restriction forced by the compound on atovaquone. Different models utilizing the flow-through technique to keep up with sink conditions have additionally been distributed; Nicklasson et al. Had the option to describe the disintegration of the sparingly solvent compound Phenacetin. Curiously, while looking at their outcomes acquired utilizing the USP 4 apparatus to those utilizing the USP 2 paddle contraption, the creators tracked down the flow-through technique, which likewise gave more effective wetting of the gems and less reliance on the example sizes paddle strategy.

A helpful element of the USP 4 is it tends to be utilized in two designs: (1) shut circle, where a predefined medium volume is reused all through the examination and (2) open-circle, where new dissolvable is constantly gone through the cell. The last strategy is accordingly appropriate for testing low dissolvability compounds, where huge media volumes are required.

Significantly, when in the open-circle design, analyte dissolvability can be expanded without the expansion of surfactants or different solvents to the disintegration medium ²⁰.

Benefits:

1. Simple to change the media pH
2. pH- profile conceivable
3. Sink conditions Burdens
4. Deaeration vital
5. High volumes of media
6. Work concentrated ¹⁵

USP Apparatus 5: (Paddle over plate).

Paddle over disc (apparatus 5) comprises a shaft and a disk gathering that can hold the example so the surface can be evened out with a paddle. It is generally ordinarily utilized for transdermal conveyance frameworks that are joined to a stainless steel disc, which is then put straightforwardly on the lower part of the vessel under the paddle ²¹. Other suitable gadgets might be utilized, don’t sorb, respond with, or slow down the example being tried. The disk get-together for holding the transdermal framework is intended to limit any “dead” volume between the disk get together and the lower part of the vessels. The disk get-together holds the framework level and is situated to such an extent that the delivery surface is equal with the lower part of the paddle cutting edge. The vessel might be covered during the test to limit vanishing ¹¹. Device 5 is utilized for the disintegration of effective and transdermal measurements structure (sublingual film of buprenorphine HCL/naloxone HCL, effective fix of diclofenac epolamine, transdermal film of estradiol and so on) ². In paddle over disc technique the paddle and vessel gathering from apparatus 2. The temperature is kept up with at 32℃ ± 0.5℃. The disk get-together holds the framework level and is situated to such an extent that the delivery surface is lined up with the lower part of the paddle sharp edge. The mechanical assembly is utilized to test transdermal patches ¹² Benefits.

1. Transdermal patches
2. Standard volume: 900ml Burden:
3. Plate assembly limits the fix size
4. Borosilicate glass
5. 17 mesh is standard (other accessible) ¹¹

USP Apparatus 6: (Cylinder).

Utilize the vessel gathering from apparatus 1 but to supplant the basket and shaft with the hardened steel chamber blending component and to keep up with the temperature at 32 ± 0.5 during the test. The measurement unit is put on the chamber toward the start of each test, to the outside of the chamber to such an extent that the long hub of the framework fits around the periphery of the chamber and eliminates caught air bubbles. Place a chamber in the apparatus, and write away pivot at the rate determined in the individual monograph ¹⁵. USP apparatus 6 utilizes vessel get together from apparatus 1 then actually basket and shaft are supplanted with pure steel cylinder mixing component. Toward the start of the estimation, the measurement unit is joined to cylinder ²². USP technique 6, nonetheless, the basket get-together is supplanted by a strong treated steel cylinder. The cylinder comprises two sections that fit together: the principal shaft/cylinder get-together and an augmentation. The expansion is utilized when the transdermal fix requires a bigger region. The benefit of these widgets is the likelihood of utilizing a standard gear (paddle); however, on the other hand, the plate get-together limits the fixed size ²¹.

USP Apparatus 7: (Responding holder).

The gathering comprises of a bunch of volumetrically adjusted arrangement compartments made of glass or other reasonable latent material, an engine and drive gathering to respond the framework in an upward direction and a bunch of appropriate example holders.

The arrangement compartments are to some extent submerged in appropriate water shower of any advantageous size that licenses keeping up with the temperature, inside the holders at 32 ± 0.5. For covered tablet drug conveyance framework join each framework to be tried to a reasonable example holder (e.g., by sticking framework edge with 2- cyanoacrylate stick onto the stick onto the finish of a plastic bar or by putting the framework into a little nylon net pack toward the finish of a plastic bar or inside a metal curl joined to a metal pole).

For transdermal medication conveyance framework connect the framework to a reasonable estimated test holder with an appropriate 0ring to such an extent that the rear of the framework is nearby and focused on the lower part of the plate ¹¹.

Mechanism of Dissolution:

1. Initial mechanical lag
2. Wetting of dosage forms
3. Infiltration of dissolution medium
4. Deterioration
5. Disaggregation
6. Disintegration
7. Occlusion of certain particles ²³

Theories of Dissolution:

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 dispersion Nernst and Brunner integrated Fick’s most memorable law of dissemination and adjusted the Noyes-Whitney’s condition to:

dc/dt = DAKw / O{Cs – Cb}/ vh

Where,

D = Diffusion coefficient of medication.

A = Surface area of dissolving solid.

Kw /o = Water / oil segment coefficient of medication

V = volume of dissolution medium.

h = thickness of a stagnant layer.

{Cs – Cb} = Concentration gradient for diffusion of drug ²³.

Danckwert’s Model / Penetration or Surface Renewal Theory: This hypothesis expects that solid solution balance is accomplished at the connection point, and mass vehicle is slowly moving toward the dissolution process. The model could be imagined as an extreme film having a concentration Ci which is not as much as immersion, as it is continually being presented to new surfaces of fluid having a concentration considerably less than Ci; as per the model, the unsettled liquid comprises of mass of eddies or bundles that are constantly being presented to new surfaces of strong and afterward conveyed back to the greater part of liquid. The Danckwert’s model is communicated by condition:

dC/dt= dm/dt = A ( Cs-Cb). √(γ.D)

Where, m-Mass of solid dissolved

𝛾- Rate of surface renewal

Interfacial Barrier Model / Double Barrier or Limited Solvation Theory:

The dispersion layer model and the Dankwert’s model depended on two suspicions:

1. The rate-deciding step that controls disintegration is the mass vehicle.
2. Strong arrangement balance is accomplished at the solid/fluid point of interaction. As per the interfacial boundary model, a transitional concentration can exist at the point of interaction because of the solvation instrument and is a component of dissolvability instead of dissemination. While considering the disintegration of the precious crystal will have an alternate interfacial obstruction given by the following condition: G = Ki (Cs- Cb)

Where,

G – Disintegration per unit area

Ki – viable interfacial transport constant ¹⁰

CONCLUSION: The dissolution research officially got underway when Noyes and Whitney deduced their condition through their dissolve studies on benzoic acid and lead chloride in 1897. In this way, dissolution was first studied as a topic in physical chemistry and continues to be a key area of study for many branches of physical sciences. The purpose of dissolution testing is to ensure the product's drug nature, which includes the ability to produce the item reproducibly maintain its delivery throughout its self-life and that the product's biopharmaceutical characteristics, such as rate and degree of absorption, can be relied upon. Therefore, encouraging dissolving experiments that can evaluate the ability of the dosage form to distribute the medicine would be appealing. Dissolution testing is a common practise for ensuring the quality of oral solid dosage forms like tablets and capsules. Additionally, it is crucial for transdermal medicine delivery systems. Dissolution testing research is continually produced. Through logical testing conducted worldwide, advancement in invention has made the process quick, easy, and reliable. It is an essential tool for developing new drugs and doing drug research.

ACKNOWLEDGEMENT: Nil

CONFLICT OF INTEREST: The authors have no conflict of interest.

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    How to cite this article:

    Thirumalaikumaran R, Lithikkaa G and Kailash KA: A review of different dissolution methods. Int J Pharm Sci & Res 2023; 14(11): 5212-21. doi: 10.13040/IJPSR.0975-8232.14(11).5212-21.

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