Compendial methods of dissolution testing

Official methods of dissolution testing

1. 1 Compendial methods of dissolution testing Under The Guidance Of: Prof . R. Nagaraju Institute of Pharmaceutical Technology Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati Andhra Pradesh, India u Submitted By: P.Reddyswetha 2018MPH40A025 M.Pharmacy 1 st Year (Pharmaceutics)

2. 2 Contents INTRODUCTION NEED OF DISSOLUTION COMPENDIAL DISSOLUTION METHODOLOGY COMPENDIAL METHODS DISSOLUTION APPARATUS CONCLUSION REFERENCES Sri Padmavathi Mahila Visvavidyalayam ( Women's University ) Tirupati

3. 3 Introduction Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

4. 4 Why we need to study dissolution in pharmaceutical sciences? Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

5. 5 Need of dissolution testing solid drugs absorbed only from the solution . Invitro test – estimate amount of drug released per unit time. Invitro dissolution test most reliable, predictors of in vivo performance. Dissolution –rate limiting factor. Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

6. 6 Compendial dissolution methodology Compendial : Reference to pharmacopoeia compendial dissolution means dissolution of dosage forms as per USP/BP/IP/EP monographs which contain all the specification and apparatus used for it. The USP-NF provides several official methods for carrying out dissolution tests of tablets,capsules and other special products such as transdermal prepartions . Compendial dissolution apparatus are those described and are generally use for oral dosage forms & suppositories , transdermal patches etc., Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

7. 7 Official dissolution Monographs Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

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10. 10 Dosage form BP IP USP EP Uncoated tablet (A)Basket Apparatus (B)Paddle Apparatus for (A) & (B) use 1000ml vessel,36.5-37.7C,pH±5%,25±2mm distance between lowest point of vessel and lowest point of rotating element . (c) flow Through Cell Apparatus : 36.5◦- 37.5◦C ,Sampling at 45 mins or as specified, flowrate ± 5% (A)Paddle Apparatus (B)Basket Apparatus. Conditions same as BP (A)Basket Apparatus (B)Paddle Apparatus Conditions used for (A)&(B) are same as in case for BP (A)Basket Apparatus (B)Paddle Apparatus Same conditions for(A)&(B) are same as in case for BP (C)flow Through Apparatus : specifically intended for Lipophillic solid dosage forms such as Suppositories & soft capsules. Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

11. 11 Coated tablet Basket and Paddle Apparatus Paddle Apparatus and Basket Apparatus Basket and Paddle Apparatus Basket and Paddle Apparatus E xtended Release ........ ......... (A)Basket and paddle Apparatus: Time –Test time points generally expressed in hours.specimens withdrawn with a tolerence of ± 2% of the stated time (B)Reciprocating cylinder (C)Flow through cell:same condition as in Basket and paddle apparatus ......... Rectal and vaginal ........ ...... ........ Same as solid dosage form Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

12. 12 Dosage form BP IP USP EP TRANSDERMAL (1)Disk assembly method:With addition of SSDA inform of a net with an aperture of 125µ.Rotate at 100 rpm/min. (2)Rotating cylinder method: Replace paddle and shaft. Rotate at 100rpm/min ....... (1)PADDLE OVER DISK:paddl e apparatus with SS disk assembly (SSDA) holding patch at the bottom vessel , temp 32±0.5◦C (2)Cylinder apparatus :similar to basket apparatus except basket is replaced by SS stirring element & maintain temp.32±0.5◦C (3) Reciprocating holder: Temp 32±0.5◦C applicable to coated drug Same as BP Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

13. 13 (3)Cell method: Rotate at 100rpm per min Delivery system, reciprocate at a frequency of 30 cycles per min with amplitude of 2 cm or as specified in monograph, time as specified. Delayed release tablet ...... ......... basket and paddle apparatus: Time as per individual monographs. after 2 hours withdrawn sample and carry out test ....... Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

14. 14 Compendial methods / official methods Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

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16. 16 Dissolution Apparatus: - The dissolution apparatus are classified into 3 categories based on the presence or absence of sink condition:- Closed-compartment apparatus:- Operated under non sink conditions. Limited volume apparatus. E.g. Beaker type apparatus such as the Rotating basket and the Paddle apparatus. Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

17. 17 Open-compartment apparatus:- This is also known as continuous flow-through. Operated by perfect sink condition. Dosage form is contained in a column . Dialysis system:- Operated under sink condition. These are used for the poorly aqueous soluble drugs. Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

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20. 20 Size 20 is more accepted to determine the rate of dissolution. Used for Capsule, Delayed release, Beads. Advantages:- Full pH change during the test Easily automated. Disadvantages:- Basket screen is clogged with gummy particles. Degassing is particularly important. Mesh gets corroded by HCl solution. Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

21. 21 USP Apparatus 2:- It is Paddle type of apparatus. Used for less soluble drugs . Parts of paddle type apparatus:- The assembly is same as that of the basket type except the rotating basket is replaced with a paddle. Used for Capsules, Tablets, Beads, Delayed release. Advantages:- Easy to use. pH change is possible. Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

22. 22 Disadvantages:- pH media change is often difficult . 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 to help position the tablet or capsule under the paddle . The sinker should not alter the dissolution characteristics of the dosage form Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

23. 23 USP Apparatus 3:- It is a Reciprocating Cylindrical apparatus. This method is less suitable for precise dissolution testing due to the amount of agitation and vibration involved. The assembly consists of A set of cylindrical flat bottomed glass vessels. A set of glass reciprocating cylinders screens. Screens made up of non-absorbing or non-reactive materials. Speed 5-35 rpm. Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

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26. 26 Used for low soluble drugs, implants, suppositories, micro particulates. Advantages:- Easy to change pH media. pH-profile possible. Sink conditions. Disadvantages:- Deaeration is necessary. High volume of media. Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

27. 27 USP 5 Apparatus:- This is the modification for apparatus 2 (Paddle over disk Apparatus) Stainless steel disk are designed for holding of the transdermal system at the bottom of the vessel. Samples are placed on the disk using an inert porous cellulosic support which reciprocated vertically. Rotation speed 25-50rpm Temperature 32℃ Volume 900ml Uses Transdermal patches, ointment s. Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

28. 28 Advantages:- Easy to handle Sink conditions are maintained. Membrane effect is minimum. Disadvantages:- Disk assembly restricts the patch size. Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

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31. 31 Disadvantages:- Investment is high. Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

32. 32 conclusion The ultimate objective of dissolution testing is to ensure adequate & reproducible bioavailability , prescribed in the monographs of IP/BP/USP/EP is to obtain about the drug release characteristics under standardized conditions. compendial testing comprises all of the analytical testing required to prove the identity, efficacy, & safety of drug products before they are packaged/distributed . Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

33. 33 References Brahmankar DM, Jaiswal SB, Biopharmaceutics and Pharmacokinetics. Applied Biopharmaceutics and pharmacokinetics 5 th edition Leon Shargel susanna wu -pong Andrew Subramanyam CVS , Biopharmaceutics and Pharmacokinetics. www.google.com. Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati

34. 34 Sri Padmavathi Mahila Visvavidyalayam ( Women's University) Tirupati