The document outlines protocols for testing the stability of herbal drugs, including selecting representative batches, developing analytical methods using marker compounds, establishing acceptance criteria, and evaluating changes over storage like hydrolysis, oxidation, and isomerization that may occur. It discusses challenges in stability testing due to complex constituents in herbal medicines and different harvesting times for combination products. The protocols are meant to standardize testing and determine shelf life for herbal drugs as for conventional medicines.
Stability testing of natural products.docxKipaPape
Stability is defined as the capacity of drug to remain within established specification limits to maintain its identity, strength, quality and purity throughout the retest or expiration dating period.
It is the ability of formulations to retain its physical, chemical, microbiological and toxicological parameters same that time of manufacturer.
Adulteration is the debasement of Genuine materials3.
It may be deliberated or accidentally done.
In crude drugs, this practice includes the substitution of the original crude drug, fully or partially with sub-stranded substances.
Sub-stranded substances include- Inferiority and spoilage.
Inferiority- Natural sub-stranded condition whose natural constituent is below the minimum standard.
Spoilage- sub-stranded condition produced by microbial or pest infestation.
Stability testing of natural products.docxKipaPape
Stability is defined as the capacity of drug to remain within established specification limits to maintain its identity, strength, quality and purity throughout the retest or expiration dating period.
It is the ability of formulations to retain its physical, chemical, microbiological and toxicological parameters same that time of manufacturer.
Adulteration is the debasement of Genuine materials3.
It may be deliberated or accidentally done.
In crude drugs, this practice includes the substitution of the original crude drug, fully or partially with sub-stranded substances.
Sub-stranded substances include- Inferiority and spoilage.
Inferiority- Natural sub-stranded condition whose natural constituent is below the minimum standard.
Spoilage- sub-stranded condition produced by microbial or pest infestation.
What is Efficacy
Why Efficacy is required for Herbal products
How Efficacy of Herbal products ensured
What are the various avenues of determining efficacy
Herbal remedies are plants used as medicine.
People use herbal remedies to help prevent or cure disease.
They use them to get relief from symptoms, boost energy, relax, or lose weight.
Herbal remedies are a type of dietary supplement. They are not medicines.
Herbals are not regulated like medicines.
Herbals do not need to be rigidly tested before they are sold.
Herbals may not work as claimed.
Labels do not need to be approved.
It may not list the correct amount of an ingredient.
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.
Regulatory requirement for setting herbal drug industryRAGHAV DOGRA
The World Health Organization (WHO) estimates that 80 percent of the population of some Asian and African countries presently use herbal medicine for some aspect of primary health care.Pharmaceuticals are prohibitively expensive for most of the world's population, half of whom lived on less than $2 U.S. per day in 2002. In comparison, herbal medicines can be grown from seed or gathered from nature for little or no cost
patent (/ˈpætənt/ or /ˈpeɪtənt/) is a set of exclusive rights granted by a sovereign state to an inventor or assignee for a limited period of time in exchange for detailed public disclosure of an invention. An invention is a solution to a specific technological problem and is a product or a process. Patents are a form of intellectual property.
Standardization of herbal drugs refers to “confirmation of its identity and determination of its quality, purity and detection of nature of adulterant by various parameters”.
In this slide contains Monographs of Herbal Drugs Study in British Herbal Pharmacopoeia and American Herbal Pharmacopoeia.
Presented by: M.SUDHEESHNA (Department of pharmaceutical analysis ).RIPER, anantapur
Herbal drugs are usually considered safe but when taken along with other drugs of chemical origin (allopathic drugs), they do interact with them and cause Bio-drug interaction
In this slide contains Introductionnof Indian pharmacopeia, ayurvedic, unani pharmacopeia and monographs of herbal drugs.
Presented by: P.SUDHEER KUMAR (Department of pharmaceutical analysis ).RIPER, anantapur
MICROBIAL CONTAMINATION IN HERBS AND THEIR FORMULATIONSVK VIKRAM VARMA
INTRODUCTION
SOURCES OF CONTAMINATION
RAW MATERIALS
PACKAGING MATERIALS
LIMITS FOR MICROBIAL CONTAMINATION
LIMITS AS PER WHO
TYPES OF CONTAMINATION
DIRECT CONTAMINATION
CROSS CONTAMINATION
DETERMINATION OF CONTAMINATION
TOTAL VIABLE COUNT
PRETREATMENT OF HERBAL MATERIALS
REFRENCES
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.
What is Efficacy
Why Efficacy is required for Herbal products
How Efficacy of Herbal products ensured
What are the various avenues of determining efficacy
Herbal remedies are plants used as medicine.
People use herbal remedies to help prevent or cure disease.
They use them to get relief from symptoms, boost energy, relax, or lose weight.
Herbal remedies are a type of dietary supplement. They are not medicines.
Herbals are not regulated like medicines.
Herbals do not need to be rigidly tested before they are sold.
Herbals may not work as claimed.
Labels do not need to be approved.
It may not list the correct amount of an ingredient.
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.
Regulatory requirement for setting herbal drug industryRAGHAV DOGRA
The World Health Organization (WHO) estimates that 80 percent of the population of some Asian and African countries presently use herbal medicine for some aspect of primary health care.Pharmaceuticals are prohibitively expensive for most of the world's population, half of whom lived on less than $2 U.S. per day in 2002. In comparison, herbal medicines can be grown from seed or gathered from nature for little or no cost
patent (/ˈpætənt/ or /ˈpeɪtənt/) is a set of exclusive rights granted by a sovereign state to an inventor or assignee for a limited period of time in exchange for detailed public disclosure of an invention. An invention is a solution to a specific technological problem and is a product or a process. Patents are a form of intellectual property.
Standardization of herbal drugs refers to “confirmation of its identity and determination of its quality, purity and detection of nature of adulterant by various parameters”.
In this slide contains Monographs of Herbal Drugs Study in British Herbal Pharmacopoeia and American Herbal Pharmacopoeia.
Presented by: M.SUDHEESHNA (Department of pharmaceutical analysis ).RIPER, anantapur
Herbal drugs are usually considered safe but when taken along with other drugs of chemical origin (allopathic drugs), they do interact with them and cause Bio-drug interaction
In this slide contains Introductionnof Indian pharmacopeia, ayurvedic, unani pharmacopeia and monographs of herbal drugs.
Presented by: P.SUDHEER KUMAR (Department of pharmaceutical analysis ).RIPER, anantapur
MICROBIAL CONTAMINATION IN HERBS AND THEIR FORMULATIONSVK VIKRAM VARMA
INTRODUCTION
SOURCES OF CONTAMINATION
RAW MATERIALS
PACKAGING MATERIALS
LIMITS FOR MICROBIAL CONTAMINATION
LIMITS AS PER WHO
TYPES OF CONTAMINATION
DIRECT CONTAMINATION
CROSS CONTAMINATION
DETERMINATION OF CONTAMINATION
TOTAL VIABLE COUNT
PRETREATMENT OF HERBAL MATERIALS
REFRENCES
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.
Role of Markers in Standardization of Herbal ProductsDr-Jitendra Patel
In this Power Point Presentation the viewer will be able to know the the different markers present naturally in herbal materials. These markers may be genitally, chemically and biochemically. How markers play major role during identification, authentication, quality control, quality assurance and determination of safety and efficacy of particular medicinal plant.
Portion covered:
1. Role of markers in standardization of herbal products
2. Factor influencing identification and quality of herbal Drugs
3. Meaning of Standardization
4. Types of Markers
5. Molecular or DNA Markers
6. Chemical Markers
7. Biochemical Markers
Natural sweetener which have low calorific value, can be used in diabetic and obese patient. some of them are taste modifying agents, which are not sweet in taste but modify the taste of sour food, can be used as natural sweetener instead of artificial sweetening agents which are high in calorie and can be harmful to our body.
Herbal excipients which are easily available, lower cost and are noncarcinogenic, which can be used to replace synthetic excipients which are carcinogenic.
Natural colorants obtained from various insects and plants, which gives harmless dying agents which can be used in food industry as well as textile industry.
Isolation, Identification and Analysis of Phytoconstituents.pptxZuli Shingala
general Isolation methods for alkaloids
isolation, identification and analysis of phytoconstituents like Caffeine, Atropine, Glycyrrhetinic acid, Podophyllotoxin
Lignans are phenyl propanoids dimer found in many plants, particularly in seeds like sesame seeds, linseed, sunflower seeds, pumkin seeds, etc. and they are having anti microbial, anti viral and anti fungal activity.
Cyanogenic glycoside which on hydrolysis gives benzaldehyde and hydrocyanic acid. examples of this glycosides are bitter almond and wild cherry bark. in this slides bitter almond is described in detail.
Black and green tea, its preparation, tea cultivation, preparation of black tea and green tea, chemical constituents (caffeine, catechin, tannins) and uses
Cultivation and collection of drugs of natural originZuli Shingala
cultivation and collection of medicinal plants, processing, storage, etc. with various factors that affects cultivation and collection of medicinal plants
Secondary metabolites from plants like Alkaloids, Glycosides, Tannins, Resins, Volatile oils and Flavonoids. with definition, introduction, Chemical properties, Classification and Identification test
evaluation of drug by organoleptic, microscopical, physical, chemical and biological methods. spectroscopical methods, chromatography, leaf constants, linear measurements.
metabolism of glucose into pyruvate or lactate depending upon the presence of oxygen. salient features of glycolysis, definition and sequence of reactions involved in glycolysis.
classification of drugs from natural origin
alphabetical, morphological, pharmacological, chemical, taxonomical, chemotaxonomical, serotaxonomical classifications are included in the presentation
herbal drugs or phytoconstituents used to improve skin texture and coloration included in the presentation with herbal fairness formulations available in the market
Sources of crude drugs (natural)
Drugs obtained from Plants, Animals, Marine, Microorganism, Mineral and from Biotechnology (plant tissue culture) are covered in the presentation
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...
Protocols for testing of herbal drugs
1. PROTOCOLS FOR TESTING OF HERBAL
DRUGS
PREPARED BY-
ZULIE SHINGALA,
GUIDE- MR. BHAVIK CHAUHAN,
ASSISTANT PROFESSOR ,
FACULTY OF PHARMACY, MSU BARODA.
1
2. • WHO has defined herbal medicines as finished labeled
medicinal product that contain an active ingredient, arial or
underground parts of the plant or other plant material or
combinations.
• According to a report of WHO , about 80% of the world
population is reported to rely on traditional medicine for their
primary health care needs.
• A report of global survey on national policy on traditional
medicine and regulation of herbal medicines indicated that
about 50 countries including China, Japan and Germany have
their national policy and laws on regulations of traditional
medicines.
• Herbal drugs posses a long history of its use and better
patient tolerance.
2
3. • These sre cheaper and easily available in India due to rich
agriculture conditions.
• Reckless utilization of resources threatens the sustainability of
several plant species.
• in 1993, the guidelines for safety and efficacy of herbal
medicines developed by an expert committee directed that
the procedures for allopathic drugs should be followed for all
traditional and herbal products to enter into clinical trials for
any therapeutic condition.
• The quality of the trial drugs has to be tested for batch to
batch uniformity of the active cnstituents.
• However, in order to further widen their acceptance, clinical
trials of these herbal products should be encouraged.
3
4. PROTOCOLS FOR STABILITY TESTING
1) Selection of batches and samples
2) Analytical procedure
3) Acceptance criteria
4) Storage conditions and storage period
5) Testing frequency
6) Evaluation
7) Statements labelling
4
5. ROLE OF MARKERS
• 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.
• Finding the “right” analytical marker is a crucial need for
stability testing of HMPs. Typical sources for finding markers
are:
• Monographs and drafts (EDQM Pharmeuropa).
• Experience, transfer from other plants/constituents.
• Literature research about known constituents.
• Scientific research
5
6. 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 UVvisible
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.
6
7. • Following is the simple example of protocols for HPLC
analysis of herbal products using marker compounds-
• Liquorice (Glycyrrhiza glabra):-
• is a popular herbal medicinal product, where glycyrrhizin is
the main active component.
• A summary of protocol presented below-
1. Nine samples of liquorice were obtained from various global
market.
2. Ground samples (15gm each) were soxhlet extracted with
methanol. the extract were filtered and evaporated under a
vaccum to dryness. The residue from the extracts of each
sample was redissolved in methanol and filtered before HPLC
analysis. The methanol extracts of all nine samples were
subjected to HPLC analysis.
7
8. • Glycyrrhizin (20mg/mL) in methanol was used as the
reference marker, and further dilution were made with
methanol and injected into HPLC to construct the calibration
curve.
• Retention time and the UV spectra were used to identify
glycyrrhizin, peak area was used to quantify the amounts of
glycyrrhizin presents in each sample.
• Glycyrrhizin percentage level in the sample is in the range
between 0.177 to 0.688 % w/w of dry sample materials.
8
9. SHELF-LIFE
• The determination of shelf life of herbal medicinal drug
products is same as chemically defined APIs, but special
nature of herbal product should be taken into consideration.
• It is recommended that in case of a herbal medicinal product
containing a natural product or a herbal drug preparation with
constituents of known therapeutic activity, the variation in
component during the proposed shelf-life should not exceed ±
5% of the initial assay value, unless justified to widen the
range up to ±10 per cent or even higher.
9
10. CHALLENGES IN STABILITY TESTING
active substances in
herbal medicinal
plants consist of
complex of
constituents.
Many herbal
compounds
are unstable.
In combined formulations,
different substances having
similar constituents give rise
to analytical challenges.
10
11. SELECTION OF BATCHES
• Long term testing is to be provided with on at least two
batches of the drug substance and three batches [10] of drug
product. In some cases of combination products, it is hardly
possible to provide the required two batches of each extract
at the same time due to different harvesting times. This
should be taken into consideration when planning the
schedule for stability study.
11
12. SELECTION OF BATCHES AND TESTING CONDITIONS
formal stability studies
- conducted on at least
three primary batches.
- Stability performed on
each individual strength
and container size till
bracketing. long term stability studies
- on at least three batches
performed under natural
conditions.
ongoing stability studies
- All products have to be
tested at least one batch
a year.
- Wherever appropriate,
bulk products are also to
be tested.
- Applies to every dosage
and packaging size anf
type.
12
13. PREDICTABLE CHANGE IN HERBAL MEDICINAL PRODUCT
• Following predictable changes may occurs in herbal medicinal
product during storage and in shelf life determination:
Hydrolysis, Oxidation, Racemization, Geometric isomerization,
Temperature, Moisture and Light.
• 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.
13
14. • Racemization: Racemization is the process in which one
enantiomer of a compound, such as an L-amino acid, converts to
the other enantiomer. The compound then alternates between
each form while the ratio between the (+) and (–) groups.
•
• Geometric isomerization:
• Geometric isomerization: Products can be change in trans or cis
form. One form may be more therapeutically active.
•
• 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.
14
15. • 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.
15
16. REFERENCE
• Challenges and guidelines for clinical trial of herbal drugs from
• www.ncbi.nlm.nih.gov
• Evidence based validation of herbal medicine by Pulok K.
Mukherjee.
• ‘Stability testing of herbal products by Anupan Kumar Sachan
and Ashutosh Kumar’ journal of chemical and pharmaceutical
research, 2015, 7(12):511-514.
16