Definition of drug interaction, potential of herb-drug interactions,significance of study of herb-drug interactions, reasons for their study, types according to ayurveda, effects & different ways of herb-drug interactions, their mechanism, hypericum, kava lava, ginkgo biloba, ginseng, garlic, pepper, ephedra.
Schedule T – Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.
INTRODUCTION
Components of GMP
GMP Provisions: Under Schedule-T are grouped
Location and surroundings
Factory Premises
Buildings
Water supply
Containers cleaning
Disposal of Waste
Requirements for the sterile products
store
Working space:
Space requirement for manufacturing of Unani medicine
Health & Hygiene
Machinery and Equipments
Machinery and equipments for maufacturing of ayurveda and siddha medicine
Documentation and Records
Definition of drug interaction, potential of herb-drug interactions,significance of study of herb-drug interactions, reasons for their study, types according to ayurveda, effects & different ways of herb-drug interactions, their mechanism, hypericum, kava lava, ginkgo biloba, ginseng, garlic, pepper, ephedra.
Schedule T – Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.
INTRODUCTION
Components of GMP
GMP Provisions: Under Schedule-T are grouped
Location and surroundings
Factory Premises
Buildings
Water supply
Containers cleaning
Disposal of Waste
Requirements for the sterile products
store
Working space:
Space requirement for manufacturing of Unani medicine
Health & Hygiene
Machinery and Equipments
Machinery and equipments for maufacturing of ayurveda and siddha medicine
Documentation and Records
Herbs, Herbal Drugs
Present Scope of Herbal Drug Industry
Scope of Herbal Drug Medicine and Industry
Indian Herbal Industry
International Scope of Herbal Medicines
World Wide Herbal Trade
Overview on plant based industries and research institutions in India
List of few herbal drug industries in India
List of few herbal research institution/ centres in India
General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on medicinal and
aromatic plants in India.
Regulations in India (ASU DTAB, ASU DCC), Regulation of
manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Introduction
Regulatory Requirements
Key function of regulatory agencies
Regulation in India
DRUG TECHNICAL ADVISORY BOARD
Drugs Consultative committee-DCC
Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Herbal Drug Technology (B.Pharm. 6th Semester)
Definition of herbs, herbal medicine, herbal medicinal product, herbal drug preparation
Source of herbs, Selection, identification and authentication of herbal materials,
Processing of herbal raw material
Herbs, Herbal Drugs
Present Scope of Herbal Drug Industry
Scope of Herbal Drug Medicine and Industry
Indian Herbal Industry
International Scope of Herbal Medicines
World Wide Herbal Trade
Overview on plant based industries and research institutions in India
List of few herbal drug industries in India
List of few herbal research institution/ centres in India
General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on medicinal and
aromatic plants in India.
Regulations in India (ASU DTAB, ASU DCC), Regulation of
manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Introduction
Regulatory Requirements
Key function of regulatory agencies
Regulation in India
DRUG TECHNICAL ADVISORY BOARD
Drugs Consultative committee-DCC
Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Herbal Drug Technology (B.Pharm. 6th Semester)
Definition of herbs, herbal medicine, herbal medicinal product, herbal drug preparation
Source of herbs, Selection, identification and authentication of herbal materials,
Processing of herbal raw material
"Pharmaceutical aids are the drugs or substances which have no or little pharmacological.but they are essentially used in the preparation of pharmaceutical dosage form
Substances that have little or no therapeutic value, but essentially used in the preparation of various pharmaceutical dosage form are called Pharmaceutical aids.
Source: Animals, Plants, minerals, synthetic.
They are not API (Active Pharmaceutical Ingredient).
Acidulants: It give sharp taste to food. Assist in the setting of gel and as a preservative. Eg- Tamarind, lemon juice, tomato.
Colouring agents: Caramel, turmeric, indigo, saffron.
Disintegrating agent: Starch, CMC.
Diluent: Cinnamon water, peppermint water, sesame oil.
Emulsifying agents: Acacia, Agar, Bentonite, Gelatin
Suspending agents: Acacia, Agar, Bentonite, Gelatin
Filter aid: Talc, Bentonite, Diatomite.
Flavoring agent: Cardamom, rose, lemon.
Lubricant: Talc, Cocoa
Preparation and Standardisation of Ayurvedic Dosage formsManjusha Kondepudi
Standardization of Asava&Arista, Churna, Bhasma, Avalehya and Gutika.
Importance of standardization of herbals
Standardization of herbal raw material, plant extract
Pharmaceutical excipients are pharmacologically inert substances which are included in the manufacturing process or are contained in a finished pharmaceutical product dosage form to alter the functions.
Challenges in herbal formulation
Steps in herbal drug formulation
Types of conventional herbal formulations
Liquid herbal dosage forms
Solid herbal dosage forms
Other herbal dosage forms
Novel dosage form
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.
In the present context, the use of food additives is imperative.
Additives provides protection against food spoilage during storage, processing, transportation and distribution.
With the present degree of urbanization, it would be impossible to maintain food distribution without processing and packing with which many additives are involved.
The convenience food revolution would be not have been possible without food additives.
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.
Objective
Definition
Animal welfare board of India
Experimentation on animals
Committee for experimentation on animals
Power of entry and inspection
Power to prohibit experiments on animals
penalties
Objectives of the Drugs and Cosmetics Act
Definitions
DRUGS TECHNICAL ADVISORY BOARD (DTAB)
GOVERNMENT ANALYST
Drug Inspectors
Regulatory provisions relating to import of cosmetics
Offences & penalties
Loan license
Requirements pertaining to labeling of cosmetics
References
A glycogen storage disease (GSD, also glycogenosis and dextrinosis) is a metabolic disorder caused by an enzyme deficiency affecting glycogen synthesis, glycogen breakdown, or glucose breakdown, typically in muscles and/or liver cells.
PREPARATION AND IN-VITRO EVALUATION OF ITRACONAZOLE LOADED NANOSPONGES FOR T...Mahewash Sana Pathan
Itraconazole is an imidazole derivative and used for the treatment of local and systemic fungal infections. It is a BCS Class II drug having very low solubility in water i.e. 1-4ng/ml. The oral use of Itraconazole is not much recommended as it has many side effects. The present research has been undertaken with the aim to develop a topical hydrogel formulation of Itraconazole loaded nanosponges to increase the solubility, permeability and stability of itraconazole. Itraconazole loaded nanosponge was prepared by emulsion solvent diffusion method by using different concentrations of ethyl cellulose as a polymer, Polyvinyl alcohol as surfactant and dichloromethane as cross linking agent. Physical characteristics of the nanosponges as well as the drug entrapment efficiency, percentage drug content, Percent yield, drug polymer compatibility, solubility studies of the nanosponges were investigated. Particle size analysis and surface morphology of nanosponges were performed. The scanning electron microscopy of nanosponges showed that they were spherical in shape and spongy in nature. Drug entrapment efficiency was found to be in the range of 42.75 % to 73.10 %. The optimized nanosponge formulation was loaded into hydrogel using carbopol 940 and studied for pH, viscosity, in vitro drug release. Of the nanosponge formulations prepared, F4 was found to show drug release of 70.62%. It was concluded that Itraconazole nanosponge hydrogel may have increased solubility and drug release
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
Presentation include chapter solubility of drugs from second yr B-Pharm
Solubility, solubility expression, solute solvent interactions, solubility parameters, solvation and dissolution, factors affecting solubility, solubility of gases in liquids, liquids in liquids, fractional distillation, azeotropes, dissolution and drug release and diffusion.
Cosmetics regulatory: includes Regulatory provision relating to manufacture of cosmetics, Schedule M (II) of D & C rule 1945 deals with requirements for the factory premises for the manufacture of cosmetic, requirement of plant & equipment, conditions of licencing, regulatory provision on sale of cosmetics, loan licence, Regulatory provision relating to import of cosmetics, offences & penalties, List of amending Act and adaptation orders.
Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
Rheology is the science that study flow of fluids. Viscosity is the main parameter of flow. Newtonian & non newtonian are the two types of flow behavior according to newtons law of flow. non-newtonian flow can be plastic, pseudoplastic, dilatant, thixotropic, antithixotropic or rheopexy. viscosity can be determined by using various viscometers such as capillary viscometer, cup & bob viscometer, cone & plate viscometer, falling sphere viscometer, brookfield viscometer, etc. factors affeting viscosity are intrinsic, extrinsic or temperature dependence.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
3. PHARMACEUTICAL EXCIPIENTS:
• According to International Pharmaceutical Excipients
Council-
“substance other than the active drug substance which
has been appropriately evaluated for safety & are included
in a drug delivery system to either aid the processing of the
drug delivery system during its manufacture, protect,
support or enhance stability, bioavailability, assist in
product identification, or enhance any other attributes of
the overall safety & effectiveness of the drug delivery
system during storage or use.”
• Pharmaceutical excipients are inactive substances added to
medicinally active compounds to formulate dosage form.
3
4. FUNCTIONS OF EXCIPIENTS
• Add bulk to the formulation
• During manufacturing, helps to handle API.
• Assist in drug administration
• Enhance patient compliance
• Enhance drug solubility & bioavailability.
• Avoid drug degradation
• Give robust & reproducible result of formulation
• Modify the pH & osmolarity of liquid dosage form.
• Helps in particle dispersion
• Helps to mask unpleasant taste, odor, color.
• Helps to maintain stability.
4
6. IDEAL PROPERTIES OF EXCIPIENTS
• They can be used practically.
• They should be non toxic & nonirritant
• Should be non volatile in nature.
• Should not be affected by temperature, light & hydrolysis.
• Should be easily available & cheap.
• Should not have specific color, odor & taste.
• Should possess good water & lipid solubility.
• Should be compatible with active ingredient in the
preparation
• Should be pharmacologically inert.
6
8. • ADVANTAGES OF HERBAL EXCIPIENTS: Natural
excipients are Biocompatible, economic, easily available, less
toxic, have soothing action & nonirritant, safe &
biodegradable, and can be chemically modified.
• DISADVANTAGES OF HERBAL EXCIPIENTS: they are
prone to microbial contamination, yield & chemical
composition of natural excipients vary in different conditions,
there are possibilities of heavy metal contamination.
8
9. CLASSIFICATION OF HERBAL EXCIPIENTS
Based on regulatory aspects-
Herbal excipients
Approved
excipients
Intermediate
category essentially
new excipients
New compounds
9
10. CLASSIFICATION OF HERBAL EXCIPIENTS
Based on Source-
Herbal
excipients
Animal source
E. g. Bees wax, cochineal, honey, etc.
Vegetable source
E.g. Pectin, starch, cardamom, vanilla, etc.
Mineral source.
E. g. bentonite, kaolin, paraffin, etc.
Marine Source
E. g. Agar, chitin, alginates, etc.
Synthetic products
E. g. PEG’s, Povidone, etc.
10
11. CLASSIFICATION OF HERBAL EXCIPIENTS
Based on Chemical nature-
Herbal
excipients
Alcohols Esters,
ethers,
Aldehydes,
carboxylic
acids.
Glyceride
s &
waxes
Carbohyd
rates
Hydrocarbon
& halogen
derivatives
Polymers
Minerals
Proteins
Preservatives,
dyes,
sweeteners,
surfactants.
11
12. CLASSIFICATION OF HERBAL EXCIPIENTS
Based on Application of excipients-
Herbal
excipients
Filler
lubrican
ts
Binders
Disinteg
rating
agents
Coating
agent
Anti
oxidant
Colouring
agent
Flavoring
agent
Buffering
agent
Solvent
Chelating
agent
Viscosity
builder
Surface
active
agent
12
13. NATURAL COLOURANTS
Natural colorants are highly colored compound capable to
impart colour to fabric, leather, drugs, cosmetics, & plastic.
Advantages of natural colorants:
1. Natural colourants are soft, lustrous and soothing.
2. Wide ranges are available.
3. They are usually renewable.
4. Eco-friendly & stable.
5. Non hazardous to human health.
6. Show some medicinal properties.
13
14. 1. HENNA
Synonym: Egyptian private, Mignonnette,
Mahendi.
B/S: Dried leaves of Lawsonia inermis, Family-
Lythraceae.
G/S: North Africa, India, Srilanka.
C/C: Lawsone (2,5-Dihydroxy-1,4-
naphthoquinone),
phenolic glycosides, coumarians,
xanthene,flavonoides,
fats,resine, tannins.
Chemical test: on addition of acid in decoction of henna, orange
red colour vanishes. On addition of alkali colour darkens.
Application: as hairdye, colourant in other cosmetics.
14
15. 2. TURMERIC
• Synonym: Haldi, Indian saffron.
• B/S: Dried, fresh rhizomes of plant Curcuma
longa, family- Zingiberaceae.
• G/S: India, china, Malaysia, Italy & Australia.
• C/C: 5% volatile oils, resin & diaryl heptanoid
yellow couring substance called as
Curcuminoids. Other phytoconstituents are
atlantone, demethoxycurcumine, tumerone,
sugars, minerals, etc.
• Chemical test: Curcumin gives crimson red
colour with sulphuric acid.
Application: As a
colourant in various
phrmaceutical
dosage forms,
cosmetics & food
products.
15
16. 3. ANNATO
• Synonym: chiote tree, lipstick tree
• B/S: dried seeds of Bixa orellana, fam-
Bixaceae.
• G/S: Central & South America, India.
• Description: Bixin occurs as orange
yellow crystals or dark red brown to red-
purple powder.
• Chemical test: annatto dissolved in
acetone shows absorbance maxima at
about 425, 475 & 487 nm.
• Applications: Colouring & coating agent
for solid & liquid pharmaceutical dosage
forms. In manufacture of wood stains &
varnishes & for silk dyeing.
16
17. 4. INDIGO
• Synonym: Neel, indigo
• B/S: Leaves of Indigo tinctoria, I.
suffruticosa, family- Leguminoseae.
• G/S: India, America, Europe, Africa.
• Description: dye occurs as dark blue
crystalline powder. Dye is insoluble in water,
alcohol or ether but soluble in DMSO,
chloroform, nitrobenzene.
• C/C: glycoside Indican, rotenoids deglelin,
dehydrodeguelin, rotenol, rotenone,
tephrosin & sumatrol.
• Application: colourant in pharmaceutical &
food industry, dyeing of jeans, etc.
17
18. NATURAL SWEETENERS
• These are the substances which are added to drug formulation
to mask bitter taste & can be used by diabetic patients also.
• Natural sweeteners are sacharide & non-saccharide type. Non-
saccharide sweeteners are of various types such as terpenoids,
dihydrochalcones, dihydrocoumarins, sweet proteins, & steroidal
saponins.
• Advantages:
1. They are non-calorific in nature.
2. Have less possible side effects.
3. Quality & quantity can be improved by modern technologies.
4. Economic
5. No rise in blood sugar level
6. Avoid decay of teeth.
18
19. 1. STEVIA
• Synonym: honey leaf, sugar leaf
• B/S: extracted from plant Stevia
rebaudiana, Family- Compositae.
• G/S: Paraguay, South brazil, Japan,
South east Asia, USA, etc.
• C/C: diterpene glycoside, Stevioside. Application: natural
calorie free sweetener in
liquid or solid foods,
beverages. Substituent
for conventional sugars.
Sweetening agent of
choice for diabetic
patients.
19
20. 2. LIQUORICE
• Synonym: Yashtimadha, mulethi,
Liquorice root.
• B/S: dried peeled, unpeeled roots &
stolons of plant Glycyrrhiza glabra,
Fam- Leguminoseae.
• G/S: mediterranean region & china,
france, italy, spain, USA, england, Asia
& India.
C/C: pentacyclic triterpenoid
saponin, Glycyrrhizin.
Chemical test: with 80%
sulphuric acid, it shows deep
yellow colour.
Application: sweetener,
flavouring agent, foam
stabilizer. 20
21. 3. SERENDIPITY BERRY
• Synonym: Monellins
• B/S: Fruits of plant Dioscoreophyllum
volkensii, family- Menispermaceae.
• G/S: Tropical Africa
• Description: Readily soluble in water,
denatures at higher temperature.
• C/C: Sweet protein, Monellin.
• Use: As table top sweetener.
21
22. 4. THAUMATIN
• Synonym: Talin, Katemafe fruit
• B/S: arils of fruits of the tropical
plant Thaumatococcus daneilli,
Fam- Marantaceae.
• G/S: West Africa
• C/C: Thaumatin protein.
• Description: 2000-10000 times
sweeter than sucrose. Water &
dilute alcohol soluble.
• Use: low caloric sweetener &
flavouring agent.
22
23. NATURAL BINDERS
• Binders are excipient which binds all ingredients used in
formulation to form suitable dosage form.
• Natural binders are less toxic, can be degraded naturally,
economic, available easily & abundantly & enhance stability &
texture to dosage form.
Binders
Solution binder
eg. Gelatin, cellulose
Dry binders
eg. MC, PEG.
23
24. 1. ACACIA
• Synonym: Indian gum, Babul.
• B/S: it is dried gummy exudation from the
stems & branches of Acacia arabica, A.
senegal, Fam- Leguminoseae.
• Description: it occurs as yellowish white or
white flakes, spherical spheres, powder,
granules, or spray dried powder.
• C/C: Arabinose, galactose, rhamnose, &
glycuronic acid.
• Chemical test: When acacia powder is
treated with lead sub acetate, it gelatinizes
the aqueous solution.
Use: As a natural
binder for tablets,
suspending agent,
emulsifying agent,
thickener. As base in
pastilles & lozenges.
24
25. 2. TRAGACANTH
• Synonym: Gum tragacanth, Persian tragacanth.
• B/S: dried gum obtained from plant Astragalus
gummifer, Fam- Fabaceae.
• G/S: Iraq, Iran, Syria, Turkey, Afghanistan, Pakistan &
Russia.
• Description: Tragacanth has flat, lamellated, curved
fragments, or straight or spirally twisted linear
pieces. It is white to yellowish in colour, translucent,
odourless with mucilagenous taste.
• C/C: water soluble & water insoluble
polysacharides. Bassorin, cellulose, starch, protein &
ash.
• Chemical test: when strong iodine solution is added
to tragacanth, it developes olive green colour.
• Use: used to make various pharmaceutical
formulations like creams, gels, & emulsions. 25
26. 3. STARCH
• Synonym: Amido, Amidon, Amylum
• B/S: it is polysaccharide obtained
from grains like corn (Zea mays) Fam- Gramineae,
potato (Solanum tuberosum) Fam- Solanaveae,
wheat (Triticum aestivum) &
rice (Oryza sativa), fam- Poaceae.
• Description: odourless, tasteless, fine white coloured powder.
Practically insoluble in cold ethanol & in cold water.
• C/C: Amylose & amylopectin & α-glucose.
• Chemical test: starch solution is heated with HCl & then neutralized
by NaOH, the solution is heated with Fehling’s solution, brick red
ppt is produced.
• Use: it is a binder of choice in wet granulation & tablet
formulation. Has wide applications in nasal, oral, periodontal novel
drug delivery system & to get site specific drug delivery.
26
27. 4. GELATIN
• Synonym: Byco, Cryogel, Instagel, Solugel
• B/S: it is a protein obtained by partial acid or alkaline hydrolysis of
animal collagen tissues like bone, skin, tendon & ligaments.
• Description: faintly yellow amber coloured vitreous, brittle solid.
Odourless & tasteless. Practically insoluble in water, most of organic
solvents, fixed oils & volatile oils. soluble in hot water, glycerol, &
acetic acid.
• C/C: Glycine (25-27%), alanine, glutamic acid, proline, arginine,
aspartic acid, hydroxy proline, isoleucine, leucine, phenyl alanine &
tryptophan.
• Chemical test: gelatin powder, when heated with soda lime, evolves
ammonia gas.
• Use: used in implantable delivery systems, mainly hard & soft
gelatin capsule. In formulation of suppositories, pastilles, pessaries,
pastes. Absorbable gelatin sponge acts as haemostatic agent.also
used in food industry & in photographic emulsion. 27
28. NATURAL DILUENTS
• Natural fillers or diluents are the substances which enhance
the bulk of solid dosage form or may dilute liquid
formulations.
• They are biodegradable, do not have toxicity, economic & eco-
friendly in nature.
• They provide proper structural form & assure proper weight
for easy administration.
28
29. 1. CELLULOSE
• Synonym: Arbocel, E460, Elcema,
Sanacel.
• B/S: It is a polysaccharide & is a
structural compound found in the cells of
plants, algae & few bacteria.
• Description; it is white, odorless, &
tasteless powder varying particle sizes.
Practically insoluble in water & most of
the organic solvents.
• Chemical test: with Schulze reagent
cellulose shows purple colour.
• Use: diluent for tablets, filler for hard
gelatin capsule, helps in direct
compression of granules, as a suspending
agent, in manufacturing of pellets & in
cosmetics & food industry.
29
30. 2. LACTOSE
• Synonym: milk sugar, Lactin, lactosum.
• B/S: It is a natural disaccharide of animal origin consisting of
galactose & glucose & obtained from milk of most of
mammals.
• Description: It is white crystalline powder, odorless, faintly
sweet taste. It is hygroscopic at high relative humidity.
• Chemical test: when lactose is mixed with water & heated on
water bath with 10M ammonia, it shows red colour.
• Use: as diluent in tablets, capsules, dry powder inhalations.
As a coating agent with sucrose. Used to prepare lyophilized
products.
30
31. 3. MANNITOL
• Synonym: Cordycepic acid, manna sugar, D-mannite, Mannogem
• B/S: It is exudation from the stem of Fraxinus ornus, fam-
Oleaceae.
• Descriptoin: It is white, crystalline powder or free flowing granules.
It is odourless, non-hygroscopic, & sweet powder. Soluble in
alkalies, ethanol(95%), glycerin & water. insoluble in ether.
• Use: diluent for tablet formulations, helps in direct compression,
acts as sweetening agent, in formulation of antacid preparations,
acts as thickening agent, plasticizer in soft gelatin capsules.
Therapeutically acts as osmotic diuretic, as diagnostic agent for
kidney function, in treatment of acute renal failure, cerebral edema
& to reduce intraocular pressure.
31
32. VISCOSITY BUILDERS
• These are the aqueous solutions to increase its viscosity
without altering properties.
• The inhibit crystal growth, improve physical stability, prevent
formation of stable crystal from metastable crystal.
• Types:
1. Natural gums E.g. acacia, tragacanth, xanthan gum, etc.
2. Cellulose derivatives E.g. Methyl cellulose, ethyl cellulose,
CMC
3. Chitosan
4. Synthetic polymers E.g. carbomer, PVA
5. Clays E.g. Magnesium aluminium silicates, bentonite, etc.
32
33. 1. XANTHAN GUM
• Synonym: corn sugar gum, Keltrol, Rhodigel.
• B/S: It is a polysaccharide produced by fermentation using the
bacterium like Xanthomonas compestris.
• Description: It is a cream or white coloured, odourless, free
flowing, fine powder. Practically insoluble in ethanol & ether,
soluble in cold or warm water. in market, it is available in potassium
& sodium salts.
• Chemical test: Xanthan gum is suspended in 0.1 N HCl, flask is
closed with formation bulb containing barium hydroxide & heated.
BaOH solution shows white turbidity.
• Use: It acts as good emulsifying agent, stabilizer & thickener,
viscosity enhancer for oral & topical pharmaceutical formulations,
cosmetics & foods. It can be added to sustained release matrix &
ophthalmic liquid dosage forms.
33
35. 2. CARRAGEENAN
• Synonym: Chondrus extract, Irish moss extract.
• B/S: It is sulphated polysaccharide obtained from the red algae
Chondrus crispus, family- Rhodophyllaceae.
• G/S: it is produced at North Atlantic coast of Europe, North
America, France, Spain, Denmark & USA.
• Description: It is yellow-brown to white coloured, coarse to fine
powder, without any taste. it is water soluble & stable at pH 9.
• C/C: It mainly consist of K, Na, ca, Mg, & ammonium sulfate esters
of galactose & 3,6-anhydrogalactose copolymers.
• Chemical test: It becomes translucent & gelatinous when soaked in
cold water.
• Use: In preparation of suspensions, emulsions, gels, creams,
lotions, eye drops, suppositories, tablets, capsules, etc. It is
excipient of choice for oral & buccal drug delivery. Also used for
microencapsulation of proteins & probiotic bacteria.
35
37. 3. GUAR GUM
• Synonym: Guaran, guar flour, Jaguar gum
• B/S: It is a galactomannan polysaccharide obtained from
endosperm of the seeds of the guar plant, Cyamopsis
tetragonoloba, family- fabaceae.
• G/S: India, Pakistan, U.S, Australia & Africa.
• Description: It is white to yellowish white powder, odorless,
blend taste, insoluble in organic solvents.
• Chemical test: with 2% lead acetate, it gives precipitate.
• Use: As a binder, disintegrant, suspending, thickening, &
stabilizing agent, in controlled release carrier dosage forms.
Commonly used in food & cosmetic industry.
37
39. DISINTEGRATING AGENTS
• They help in dispersion or disintegration of tablets & release
contents of capsules into small fragments.
• They act by various mechanism such as swelling , penetration,
de formation & repelling.
• They are effective in low concentration, do not affect
compressibility, more effective at intra-granular region.
• But, they have high cost, can cause side effects, have less
patient compliance.
39
40. 1. CHITOSAN
• Synonym: Deacetylated chitin.
• B/S: it is natural polysaccharide obtained from crab and
shrimp shells.
• Description: Odourles, white or creamy-whit powder or
flakes, sparingly soluble in water & conc. Organic acids.
• Chemical tests: with iodine and 10% sulphuric acid, it forms
deep violet colour
• Use: used in controlled drug delivery , mucoadhesive dosage
forms rapid release, improved peptide delivery, colonic drug
delivery systems, and for
40
41. 2. PREGELATINIZED STARCH
• Synonym: Compressible starch, Intastarch, Pharma-Gel, Prejel
• B/S: It is obtained from modification of potato starch.
• Description: It occurs as a moderately coarse to fine, white to
off-white colored powder which is odourless & has
characteristic taste. Practically soluble in organic solvents,
slightly soluble in cold water.
• Composition: 5% free amylose, 15% amylopectin, 80%
unmodified starch
• Chemical test: When solution is treated with iodine solution,
it forms reddish violet to blue color.
• Use: as a disintegrants, binder & diluent in tablets & capsules.
41
42. 3. MICROCRYSTALLINE CELLULOSE
• Synonym: Avicel, Celex, Cellulose gel
• B/S: obtained from partial depolymerisation of cellulose.
• Description: white, odorless, tasteless, crystalline powder
having porous particles. Slightly soluble in 5%w/v NaOH
solution & practically insoluble in water, dilute acids & organic
solvents.
• Chemical test: it is heated with phosphoric acid & catechol for
30 min, produce red color.
• Use: as a lubricant, disintegrating agent, binder or diluent in
oral tablet & capsule formulations.
42
43. NATURAL PERFUMES & FLAVOURING AGENTS
• Natural perfume are the mixture of essential oils or aromatic
compounds, fixatives, & solvents applied to the human body,
animal, food objects, pharmaceutical products & living spaces.
• Flavours are taste masking agents used to mask the
unpleasant taste or odour of dosage form & enhance the
flavour of medicine & patient compliance.
43
44. 1. SANDAL WOOD OIL
• Synonym: Chandan
• B/S: it is volatile oil obtained by steam distillation of
heartwood of Santalum album & S. spicatum, Family-
Santalaceae.
• Description: colorless to golden yellow in color with pleasant
woody odor. It is oily, viscous liquid, soluble in 5 vol of 70%
alcohol.
• Use: in aromatherapy, in cosmetics, soap, perfue, to treat
common cold, bronchitis, UTI & inflamation.
44
45. 2. ROSE OIL
• Synonym: Otto of rose, Attar of rose, Rose essence.
• B/S: It is volatile oil obtained by distillation of fresh flowers of
Rosa damascena, R. centifolia, family- Rosaceae.
• Description: colourless or yellow liquid with characteristic
odour of rose, rose oil is miscible in 1ml chloroform.
• Chemical test: rose oil is mixed with equal quantity of
chloroform & 90% alcohol, At 20°C, it deposits crystals within
5 min.
• Use: flavouring agent, perfume, hydrate dry skin, to treat
acne, reduces signs of ageing, scars & to treat eczema.
45
46. 3. LEMON OIL
• Synonym: Limbu, oleum limonis
• B/S: obtained from fresh peel of the ripe fruits of Citrus
lemon, Family- Rutaceae.
• Description: pale greenish-yellow in colour with sharp, fresh
smell, bitter taste & has watery viscosity.
• Chemical test: solution of lemon oil with 3 vol of alcohol is
neutral to slightly acidic in nature.
• Use: Flavouring agent, perfume, treat fever, throat infections,
bronchitis, asthma, constipation, dyspepsia & flu.
46