Stability Testing- Herbals- Durgashree Diwakar

The ability of a pharmaceutical product to retain its chemical, physical, microbiological and biopharmaceutical properties within specified limits throughout its shelf-life.
The stability testing of herbal products check the quality of herbal products which varies with the time under the influence of environmental factors, such as temperature, humidity, light, oxygen, moisture, other ingredient or excipient in the dosage form.

1. STABILITY TESTING OF NATURAL PRODUCTS BY- DURGASHREE.M.D M.PHARM, PHARMACOGNOSY KLE COLLEGE OF PHARMACY BENGALURU 1

2. CONTENTS Introduction Objectives Types of Stability Studies Predictable changes in Herbal Product Challenges in Stability testing of HMP Steps to Overcome Challenges Stability Protocol 2

3. INTRODUCTION The ability of a pharmaceutical product to retain its chemical, physical, microbiological and biopharmaceutical properties within specified limits throughout its shelf-life. (1) The stability testing of herbal products check the quality of herbal products which varies with the time under the influence of environmental factors, such as temperature, humidity, light, oxygen, moisture, other ingredient or excipient in the dosage form. 3

4. CONT…. The most important aspect in the evaluation of the stability study of a product is its storage condition. The purpose of a stability testing is to provide proof on how the quality of the herbal products varies with the time. Based on the climatic conditions only storage conditions can be determined. (2) 4

5. OBJECTIVES To provide evidence on how the quality of active substance varies with time. To establish re-test period for active substance. To establish shelf life of finished products. To evaluate efficacy of drug. To develop suitable packing information for drug product. To submit stability information for regulatory agencies. (3) 5

6. TYPES OF STABILITY TESTING 6

7. TYPES OF STABILITY TESTING Physical Stability Study : Appearance , uniformity, palatability, Dissolution and suspend ability are maintained. Chemical Stability Study : API should retain its chemical integrity and potency, so this involves drug assay and determination of drug degradation Microbial Stability Study : Sterility or resistance to microbial growth is maintained as per the specific requirement. Therapeutic Stability Study : There should be no change in therapeutic effect. Toxicological Stability Study : No Significant increase in Toxicity should occur. (3) 7

8. PREDICTABLE CHANGES IN HERBAL PRODUCT Hydrolysis : Reaction with water takes place results in degradation of product. Oxidation : Due to addition of electro negative atom (o), Removal of electro positive atom, radicals formation results in decomposition of natural products. Racemization : Racemization is the process in which one enantiomer of a compound, such as an L-amino acid, converts to the other enantiomer. Geometric isomerization : Products can be change in trans or cis form. One form may be more therapeutically active. 8

9. CONT… Polymerization : There is combination of two or more identical molecule to form much larger & more complex molecule. Temperature : The rate of most chemical increase with increase in temperature. So that “Tropical” area must be taken in consideration during preparation of the formula of the herbal substance. Moisture : Moisture absorbed on to the surface of solid drug will often increase the rate of decomposition, if it is susceptible to the hydrolysis. Light : Many type of chemical reaction induced by exposure to light of high energy. Autoxidation of volatile oil / fixed oil takes place and substance becomes colored. 9

10. CHALLENGES IN STABILITY TESTING OF HMP Active substances in HMPs consist of complex mixtures of constituents and in most cases therapeutic effects are unknown. The situation is further complicated when two or more herbal substances are combined in a HMP. In combinations of herbal substances in HMPs, they have similar constituents which gives rise to even more analytical challenges. In addition, many herbal preparations are known to be unstable. 10

11. STEPS TO OVERCOME CHALLENGES 1.Use of Marker for Herbal medicinal products Markers are chemically known compounds, which may or may not have therapeutic effect, use to calculate the quantity of herbal medicinal ingredients in herbal medicinal products. Source of Marker Monographs and drafts (EDQM Pharmeuropa ). Experience, transfer from other plants/constituents. Literature research about known constituents. Scientific research. 11

12. CONT… 2.Analytical methods for Herbal products The analysis of herbal preparations is mostly done by Running high performance liquid chromatography (HPLC)or Gas chromatography (GC) and thin layer chromatography (TLC) methods, Quantitative determinations by UV-visible spectroscopy or combinations of these. HPLC and GC methods can be used for identification and purity testing, as well as the detection of single compounds for assay, is possible during one analysis. LC and GC mass coupling are the also tools for determination but, they are highly sophisticated and expensive methods. (3) 12

13. Stability zones 13

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16. STABILITY PROTOCOL 16

17. Stability Protocol 17

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23. REFRENCES 1.Annex 5- Guidelines for Stability Testing. 2. Stability Testing of Herbal Products - Anupam Kumar Sachan and Ashutosh Kumar ( Journal of Chemical and Pharmaceutical Research, 2015, 7(12):511-514 ) 3. Stability Testing of Natural Products- Slideshare ( https://www.slideshare.net/SudhindraKini/stability-testing-of-herbal-natural-products-and-its ) 23

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