DISSOLUTION APPARATUS

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AN OVERVIEW ON DISSOLUTION APPARATUS

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DISSOLUTION APPARATUS :

DISSOLUTION APPARATUS BY: RAKHI GAWDE

TYPES OF DISSOLUTION APPARATUS :  :

TYPES OF DISSOLUTION APPARATUS : USP dissolution apparatus (official): 1:Basket type 2:Paddle type 3:Reciprocating cylinder 4:Flow through cell 5:Paddle over disc 6:Rotating cylinder 7:Reciprocating disc

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USP dissolution apparatus (non-official): Rotating bottle method. Diffusion cell. Peristalisis method. Intrinsic dissolution method.

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IP dissolution apparatus : 1:Paddle type 2:Basket type BP dissolution apparatus : 1:Basket type apparatus 2:Paddle type apparatus 3:Flow through cell

IDEAL FEATURES OF DISSOLUTION APPARATUS :

IDEAL FEATURES OF DISSOLUTION APPARATUS

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The fabrication dimensions and positioning of all components must be precisely specified and reproducible ,run to run. Must be simply design easy to operate and useable under variety of conditions. Must be sensitive to reveal process changes and formulations differences but still yield repeatable results under identical conditions.

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The apparatus in, most cases , should permit controlled but variable intensity of ; mild uniform non turbulent liquid agitation. Uniform flow is very essential because changes in hydrodynamic flow will modify dissolution. Nearly perfect sink conditions should be maintained.

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Apparatus should provide easy means of introducing the dosage form into dissolution medium and holding it, once immersed in a regular and reliable fashion. It should provide minimum abrasion to the the dosage form during test period to avoid disruption of the microenvironment sorrounding the dissolving form. Special care should be taken that medium must not evaporate from container of apparatus.

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Sample should be easily withdrawn for automatic or manual analysis without interrupting the flow characterstics of liquid. Apparatus should capable of allowing the evaluation of disintegrating,non disintegrating, floating tablets or capsules, finely powdered drugs and novel solid dosage forms.

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APPARATUS NAME DRUG PRODUCT Apparatus I Rotating basket Tablets Apparatus II Paddle Tablets . capsules modified drug  products Apparatus III Reciprocating cylinder Extended-release drug products. Apparatus IV Flow cell Drug products containing low-water-soluble drug Apparatus V Paddle over disk Tr ansdermal drug products. Apparatus VI Cylinder Transdermal drug products. Apparatus VII Reciprocating disk Extended-release drug products Apparatus VIII ( Non-USP-NF) Extended-release drug products(beads) Apparatus IX ( Non-USP-NF) Ointments, creams , transdermal drug products.

USP dissolution apparatus (official): :

USP dissolution apparatus (official): USP Apparatus 1 :Basket type a)Vessel :-Made up of borosilicate glass -Semi hemispherical bottom -Capacity 1000ml b)Shaft : -Stainless steel 316 -Rotates smoothly without significance wobble

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c)Basket :- Stainless steel 316 -Gold coatings up to 0.0001 inch d) Waterbath : Maintained at 37±0.5⁰c : Used for: Capsules,tablets,delayed release, suppositories,floating dosage forms

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The rotating basket apparatus consists of a cylindrical basket held by a motor shaft. The basket holds the sample and rotates in a round flask containing the dissolution medium. The entire flask is immersed in a constant-temperature bath set at 37°C. The rotating speed and the position of the basket must meet spe¬cific requirements set forth in the current USP. The most common rotating speed for the basket method is 100 rpm.

APPARATUS 2:PADDLE TYPE: :  :

APPARATUS 2:PADDLE TYPE: : Design: 1.Vessel 2.Shaft: The blade passes through shaft so that bottom of blade fuses with bottom of shaft. 3.Stirring elements : Made of teflon For laboratory purpose -Stainless steel

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4.Waterbath : Maintain at 37±0.5⁰c 5.Sinkers: Platinum wire used to prevent capsule /tablet from floating

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The paddle apparatus 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 controlled40 speed. 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 370C, similar to the rotating-basket method.

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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 most common operating speed for Apparatus II are 50 rpm for solid oral dosage forms and 25 rpm for suspensions. Apparatus II 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.

USP Apparatus III (Reciprocating Cylinder)  :

USP Apparatus III (Reciprocating Cylinder) Design: 1.Vessel :Cylindrical flat bottom glass vessel 2.Agitation type :Reciprocating -Generally 5-35 rpm 3.Volume of dissolution fluids :200-250 ml 4.Water bath: Maintain at 37±0.5⁰c Use : Extended release

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The USP Apparatus III is considered as the first line apparatus in product development of controlled-release preparations, because of its usefulness and convenience in exposing products to mechanical as well as a variety of physicochemical conditions which may influence the release of products in the GI tract. The particular advantage of this apparatus is the technically easy and problem free use of test solutions with different pH values for each time interval. It also avoids cone formation for disintegrating (immediate release) products, which can be encountered with the USP apparatus II.

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An additional advantage of apparatus III includes the feasibility of drug-release testing of chewable tablets. Chewable tablets for human use do not contain disintegrants , so they need to undergo physiological grinding (i.e., chewing) prior to dissolution .

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For example, enteric-coated/sustained release dosage forms, and also offers the advantages of mimicking the changes in physiochemical conditions and extraordinarily strong mechanical forces experienced by the drug products in the mouth or at certain locations in the GI tract, such as the pylorus and the ileocecal valve. Apparatus III is currently commercially available with seven columns of six rows, each row consisting of a set of cylindrical, flat bottomed glass outer vessels .

APPARATUS 4:FLOW THROUGH CELL   :

APPARATUS 4:FLOW THROUGH CELL Design : 1.Reservoir :For dissolution medium 2.Pump :-Forces dissolution medium through cell -holding a sample -Flow rate 10-100 ml/min -Laminar flow is maintained - peristaltic/centrifugal pumps are not recommended. 3.Water bath : Maintain at 37±0.5⁰c

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It is of two types ( a ) Open system: The open system has a configuration where fresh medium is pumped through the cell and the fractions are collected. This set up enables that the dissolution test is always performed at the best possible sink conditions. Every 30 to 60 minutes fractions are collected which results in rather high fraction volumes. A typical flow rate of 16 ml/min with a 30 min fraction interval results in a fraction volume of 480ml. This is not very practicable for the laboratory and therefore a volume splitting device (splitter) is used. The splitter manages a three way valve time controlled from collection to waste. Typically only 10% of the eluate would be collected which results in 48 ml fractions. Also pH changes are easily performed.

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(b) Closed system: The closed system is a configuration in which medium is pumped in circle and not replaced by fresh medium. The eluate is collected in a beaker which is stirred with a magnetic stirrer . Samples are taken from the beaker or readings on-line with spectrophotometer to measure the cumulated concentration of drug whereas in an open system the released drug over a time period is measured. The closed system is a configuration which is similar to the stirrer methods as the volume is limited and the released drug is cumulating over time . This configuration is used for drug products having a very low dosage strength and essentially it can be performed with very small volumes. Typical examples are implants.

APPARATUS 5:PADDLE OVER DISK :

APPARATUS 5:PADDLE OVER DISK 1.Vessel 2.Shaft 3.Stirring elements 4.Sample holder :Disk assembly that hold the product in such a way that release surface is parallel with paddle.Paddle is directly attached over disk assembly.Samples are drawn away b/w the surface of medium and top of paddle blade. 5.Volume :900ml 6.Temperature :32 ⁰c

APPARATUS 6:ROTATING CYLINDER : :

APPARATUS 6:ROTATING CYLINDER : 1.Vessel :In place of basket cylinder is used 2.Cylinder :Stainless steel 316. 3.Sample :-Mounted to cuprophan (inner porous cellulosic material) an entire system is adhere to cylinder. -Dosage unit is place in cylinder and released from outside 4.waterbath : Maintain at 32±0.5⁰c Disadvantage : Transdermal patches can be studied but cannot be cut into small size.

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ROTATING SHAFT DIE HOLDER DIE DRUG PELLET

APPARATUS 7:RECIPROCATING DISK:

APPARATUS 7:RECIPROCATING DISK 1.Vessel :Flat bottom cylindrical vessel -Volume of dissolution medium 50-200ml 2.Shaft 3.Sample :Placed on disk shaped holders. 4.Agitation :-Reciprocation -Reciprocating frequency 30 cycles/min. 5.Waterbath : Maintain at 32±0.5⁰c Use : Transdermal patches

IP DISSOLUTION APPARATUS:

IP DISSOLUTION APPARATUS

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Paddle type The apparatus consists of : A cylindrical vessel of borosilicate glass or other suitable transparent material with a hemispherical bottom and a nominal capacity of 1000 ml ; a cover is fitted to retard evaporation; the cover has a central hole to accommodate the shaft of the stirrer and other holes for the thermometer and the devices used to withdraw liquid.

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A stirrer consisting of a vertical shaft to the lower end of which is attached a blade having the form of that part of a circle subtended by 2 parallel chords;the blade passes through the diameter of the shaft so that the bottom of the blade is flush with the bottom of the shaft ; the shaft Is placed so that its axis is within 2mm of the axis of the Vessel and the bottom of the blade is 25±2mm from the inner bottom of the vessel ; the upper part of the shaft is Connected to a motor provided with a speed regulator; the stirrer rotates smoothly without significant wobble. A water-bath that will maintain the dissolution medium at37±0.5°

Basket apparatus.:

Basket apparatus. The apparatus consists of : A vessel identical with that described for the paddle apparatus ; A stirrer consisting of a vertical shaft to the lower part of which is attached a cylindrical basket ; the basket has 2 parts : the upper part, with a 2 mm vent, is welded to the shaft and has 3 spring clips or other suitable device that allows removal of the lower part of the basket for introduction of the preparation to be examined and firmly holds the lower part concentric with the axis of the vessel during rotation;

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The lower part of the basket is made of welded-seam cloth formed into a cylinder with a narrow rim of sheet metal around the top and bottom; unless otherwise prescribed, the cloth has a wire thickness of 0.254 mm in diameter and 0.381 mm square openings; a basket with a goldcoating 2.5µm thick may be used forTests carried out in dilute acid medium; the bottom of the basket is 25 ± 2 mm from the inner bottom of the vessel During the test;theupperpart of the shaft is connected to a motor provided with a speed regulator ; the stirrer rotates smoothly without significant wobble;a water-bath that will maintain the dissolution medium at37±0.5°C.

Dissolution Media:

Dissolution Media

Required ‘major’ Characteristic of a Dissolution Medium :

Required ‘major’ Characteristic of a Dissolution Medium Since the objective of drug dissolution testing is to assess the expected drug dissolution in the GI tract, the medium should be representative of the liquid-phase present in the tract, which is aqueous. Therefore, to be physiologically or bio-relevant, the dissolution medium has to be water or water-based. However, one may not use media such as potassium or sodium hydroxide solutions which, although water-based, their use is restricted by their high pH values not found in the GI tract.

Types of dissolution media:

Types of dissolution media Purified water Dilute acid (0.001 N-0.1 N HCl ) Simulated gastric fluid (with or without enzymes)

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Simulated intestinal fluid (with or without enzymes) Surfactants (with or without acids or buffers) Buffered aqueous solution (pH 4-8)

Selection of dissolution media:

Selection of dissolution media Oral formulation Physiological pH pH 1.2-6.8 for IR formulations pH 1.2-7.5 for MR formulations Low solubility compounds Surfactants (e.g., polysorbate , SLS, bile) wetting agent solubilizing agent

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