SEDATIVES AND HYPNOTICS
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TMUINTRODUCTION CLASSIFICATION: SEDATIVE AND HYPNOTICS BARBITURATES BENZODIAZEPINES SITE OF ACTION MECHANISM OF ACTION NEWER NONBENZODIAZEPINES HYPNOTICS PHARMACOKINETICS SIDE EFFECTS Mechanism of action Benzodiazepines Increase frequency of opening of cl- channels induced by GABA. Increase binding of GABA to GABA® receptor. Reduction of anxiety. Reduce anxiety by selectively enhancing GABAergic transmission in neurons having the α-2 subunit in their GABA® receptor. The hypnotic effect are mediated by α1-GABA® receptor Anticonvulsant effect is partially although not completely, mediated by α1-GABA® receptors.
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This document provides information about sedatives and hypnotics. It defines sedatives as drugs that reduce excitement and calm patients without inducing sleep, while hypnotics produce sleep resembling natural sleep. Both act through facilitating GABA neurotransmission. Common classes discussed are benzodiazepines, barbiturates, antihistamines, and other newer non-benzodiazepine drugs. Their mechanisms, clinical uses, and side effects are explained. Sedatives are used to relieve anxiety and cause sedation, while hypnotics are used for sleep initiation or maintenance.
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STABILITY STUDIES
INTRODUCTION
FACTORS EFFECTING STABILITY
OBJECTIVE
TYPES OF STABILITY
TYPES OF STABILITY THAT MUST BE CONSIDERED FOR ANY DRUG
REGULATORY REQUIREMENTS
STABILITY STUDIES FOR PHARMACEUTICAL PRODUCTS
DEGRADATIVE PATHWAYS
Stability studies are performed in life sciences, chemical, and food and beverage industries to determine the effects of environmental conditions on product quality. Environmental conditions can impact product shelf life, and the viability of product formulation.
DEFINATION
The capacity of a drug or product to remain within established specifications of identity, quality, purity in a specific period of time.
The capacity or the capability of a particular formulation in a specific container to remain with in particular chemical, microbiological, therapeutically, and toxicological specifications.
USP defines stability of pharmaceutical product as, "extent to which a product retains with in specified limits and throughout its period of storage and use (i.e. shelf life).
The capacity or the capability of a particular formulation in a specific container to remain with in particular chemical, microbiological, therapeutically, and toxicological specifications.
USP defines stability of pharmaceutical product as, "extent to which a product retains with in specified limits and throughout its period of storage and use (i.e. shelf life).
The primary factors effecting stability:
PH, Temperature, Moisture, humidity, light, Storage closure and containers Oxygen.
The major factors effecting drug stability are:
Particle size (suspension and emulsion), PH, additives and molecular binding and diffusion of drugs and excipients.
EXTRAPOLATION OF IN VITRO DATA TO PRECLINICAL
In vivo is the Latin word which means with in the living body.
When effects of various biological entities are tested on whole, living organism or cells, usually animals including humans and plants.
Animal testing and clinical trials are major elements of in-vivo research.
In vivo testing is often employed over in vitro because it is better suited for observing the overall effects of an experiment on a living subject in drug discovery.
example, verification of efficacy in vivo is crucial, because in vitro assays can sometimes yield misleading results with drug.
Harry Smith found that sterile filtrates of serum from animals infected with Bacillus anthracis were lethal for other animals, whereas extracts of culture fluid from the same organism grown in vitro were not.
In microbiology Once cells are disrupted and individual parts are tested or analyzed, this is known as in vitro.
In vitro studies within the glass, i.e., in a laboratory environment using test tubes, petri dishes, etc. Examples of investigations in vivo include: the pathogenesis of disease.
In vitro toxicology:-
The bridge exists between new drug discovery and drug development.-
Provide information on mechanism of action of a drug
Provides an early indication of the potential for some kinds of toxic effects, allowing a decision to terminate or to proceed further.
In vitro methods are widely used for:-
Screening and ranking chemicals
Get a platform for animal studies for physiological actions
Studying cell, tissue, or target specific effects
Improve subsequent study design
Advantages and Disadvantages:-
Faster than in vivo studies
Less expensive to run
Less predictive of toxicity in intact organisms
In vitro to in vivo extrapolation (IVIVE) refers to the qualitative or quantitative transposition of experimental results or observations made in vitro to predict phenomena in vivo, biological organisms.
The problem of transposing in vitro results is particularly acute in areas such as toxicology where animal experiments are being phased out and are increasingly being replaced by alternative tests.
Results obtained from in vitro experiments cannot often be directly applied to predict biological responses of organisms to chemical exposure in vivo.
Therefore, it is extremely important to build a consistent and reliable in vitro to in vivo extrapolation method.
Two solutions are now commonly accepted:
Increasing the complexity of in vitro systems where multiple cells can interact with each other in order recapitulate cell-cell interactions present in tissues (as in "human on chip" systems).
Using mathematical modeling to numerically simulate the behavior of a complex system, whereby in vitro data provides the parameter values for developing a model.
The two approaches can be applied simultaneously allowing in vitro systems to provide adequate data for the development of mathematical models. To comply with push for the development of alternative testing methods.
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STABILITY STUDIES
INTRODUCTION
FACTORS EFFECTING STABILITY
OBJECTIVE
TYPES OF STABILITY
TYPES OF STABILITY THAT MUST BE CONSIDERED FOR ANY DRUG
REGULATORY REQUIREMENTS
STABILITY STUDIES FOR PHARMACEUTICAL PRODUCTS
DEGRADATIVE PATHWAYS
Stability studies are performed in life sciences, chemical, and food and beverage industries to determine the effects of environmental conditions on product quality. Environmental conditions can impact product shelf life, and the viability of product formulation.
DEFINATION
The capacity of a drug or product to remain within established specifications of identity, quality, purity in a specific period of time.
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USP defines stability of pharmaceutical product as, "extent to which a product retains with in specified limits and throughout its period of storage and use (i.e. shelf life).
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In vivo is the Latin word which means with in the living body.
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In vivo testing is often employed over in vitro because it is better suited for observing the overall effects of an experiment on a living subject in drug discovery.
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The bridge exists between new drug discovery and drug development.-
Provide information on mechanism of action of a drug
Provides an early indication of the potential for some kinds of toxic effects, allowing a decision to terminate or to proceed further.
In vitro methods are widely used for:-
Screening and ranking chemicals
Get a platform for animal studies for physiological actions
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Faster than in vivo studies
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In vitro to in vivo extrapolation (IVIVE) refers to the qualitative or quantitative transposition of experimental results or observations made in vitro to predict phenomena in vivo, biological organisms.
The problem of transposing in vitro results is particularly acute in areas such as toxicology where animal experiments are being phased out and are increasingly being replaced by alternative tests.
Results obtained from in vitro experiments cannot often be directly applied to predict biological responses of organisms to chemical exposure in vivo.
Therefore, it is extremely important to build a consistent and reliable in vitro to in vivo extrapolation method.
Two solutions are now commonly accepted:
Increasing the complexity of in vitro systems where multiple cells can interact with each other in order recapitulate cell-cell interactions present in tissues (as in "human on chip" systems).
Using mathematical modeling to numerically simulate the behavior of a complex system, whereby in vitro data provides the parameter values for developing a model.
The two approaches can be applied simultaneously allowing in vitro systems to provide adequate data for the development of mathematical models. To comply with push for the development of alternative testing methods.
Immunomodulators ppt.pptx
Immunomodulation is modulation (regulatory adjustment) of the immune system. It has natural and human-induced forms, and thus the word can refer to the following:
Homeostasis in the immune system, whereby the system self-regulates to adjust immune responses to adaptive rather than maladaptive levels (using regulatory T cells, cell signaling molecules, and so forth)
Immunomodulation as part of immunotherapy, in which immune responses are induced, amplified, attenuated, or prevented according to therapeutic goals
Immunosuppressants:-
Immunosuppressants stop your immune system from damaging healthy cells and tissues. People with organ transplants and stem cell transplants take these medicines to prevent transplant rejections. The drugs also treat autoimmune disease symptoms. Immunosuppressants are powerful drugs that require careful monitoring to avoid problems.
POLYMERS
Introduction
Types of polymer
Classification of Polymer
Polymerization
Biodegradable Polymer
Application of biodegradable polymer
Natural polymer
They occur naturally and are found in plants and animals. For example, proteins, starch, cellulose, and rubber. To add up, we also have biodegradable polymers called biopolymers.
Semi-synthetic Polymers:
They are derived from naturally occurring polymers and undergo further chemical modification. For example, cellulose nitrate, and cellulose acetate.
Synthetic Polymers
These are man-made polymers. Plastic is the most common and widely used synthetic polymer. It is used in industries and various dairy products. For example, nylon-6, 6, polyether’s etc.
Thermosetting polymers These polymers greatly improve the material’s mechanical properties. It provides enhanced chemical and heat resistance. For example, phenolics, epoxies, and silicones. Addition Polymerization: For Example, poly ethane, Teflon, Polyvinyl chloride (PVC) Condensation Polymerization: Example, Nylon -6, 6, perylene, polyesters.
Medicines and Healthcare products Regulatory Agency(MHRA)
What are regulatory bodies:- In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing. marketing and labeling of pharmaceutical products like:
USFDA(USA)
MHRA(UK)
TGA(Australia
AIMS:- Protecting public health through regulation, with acceptablebenefit-risk profiles for medicines and devices.
Promoting public health by helping people who use these productsto understand their benefits and risks.
Improving public health by encouraging and facilitating developments in products that will benefit people
GUIDELINES:- Guidelines for Manufacturers on Clinical Investigations to be carried out in the UK.
Inspected UK Contract GMP Quality Control Laboratories.
BLUE GUIDE: Advertising and Promotion of medicines in the UK.
ORANGE GUIDE: Rules and Guidelines for Pharmaceutical Manufacturers and Distributors.
Good Pharmacovigilance Practice Guide.
Guidelines on Process Validation
Guide to UK GLP Regulations 1999
Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products.
Guide to defective medicinal products.
Introduction of a Risk Based Inspection Programme for GMP Labs.
SALIENT FEATURES, COMMITTEES/WORKING GROUPS:-
MHRA has the power to withdraw a product from market and suspend production of medicines.
A manufacturer or distributor can be prosecuted if the law has been broken.
Regulatory decisions are impartial D Different products are treated differently.
MHRA collaborates with :
US Food and Drug Administration
NPSA National Patient Safety Agency
NICE National Institute for Health and Clinical Excellence
REGULATORY REQUIRMENT FOR PRODUCT APPROVAL.pptx
1.Introduction
2.API sourcing
3.API sourcing in other Countries
4.Regulatory filing
5.DMFs
6.Regulatory Guideline for API
7. Compression study of active pharmaceutical ingredients in different countries
8.Filling issue
GENOMIC AND PROTEOMIC TOOLS
WORKING PRINCIPLE AND APPLICATIONS OF GENOMIC AND PROTEOMIC TOOLS
DNA ELECTROPHORESIS
POLYMERASE CHAIN REACTION (PCR)
REVERSE TRANSCRIPTION PCR (RT-PCR)
MICROARRAY TECHINIQUE
ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
WESTERN BLOTTING
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SEDATIVES AND HYPNOTICS
- 1. SEDATIVES AND HYPNOTICS A SEMINAR OF MASTER OF PHARMACY IN PHARMACOLOGY BY PRAKHAR VARSHNEY M.PHARM (PHARMACOLOGY) 1ST SEM 1STYEAR SUBJECT CODE - MPL102T SUBJECT NAME- ADVANCED PHARMACOLOGY – I DEPARTMENT OF PHARMACOLOGY TEERTHANKER MAHAVEER COLLEGE OF PHARMACY TEERTHANKER MAHAVEER UNIVERSITY MORADABAD INDIA SESSION: 2022-2023 1
- 2. CONTENTS 1. INTRODUCTION 2. CLASSIFICATION: SEDATIVE AND HYPNOTICS 3. BARBITURATES 4. BENZODIAZEPINES 5. SITE OF ACTION 6. MECHANISM OF ACTION 7. NEWER NONBENZODIAZEPINES HYPNOTICS 8. PHARMACOKINETICS 9. SIDE EFFECTS 10. REFERENCES 2
- 3. INTRODUCTION Sedatives and hypnotics used to treat Insomnia (poor sleeping). SEDATIVES:- A drug that reduces excitement, calms the subject without inducing sleep. Ex:-Phenobarbitone, Thiopentone, Alperazolam , Oxazepam HYPNOTICS:- A drug which produces sleep resembling natural sleep. Hypnotics are used to maintain the sleep. Ex:-diazepam, clonazepam, clobazam 3
- 4. TRANSIENT INSOMNIA 1-3 DAYS SHORT ACTING INSOMNIA 3-21 DAYS CHRONIC INSOMNIA >3 DAYS I N S O M I N A INSOMNIA are related to poor sleeping habits, depression, anxiety, lack of exercise, chronic illness
- 6. BENZODIAZEPINES ARE A CLASS OF DRUGS THAT CAN TREAT RANGE OF CONDITIONS. DOCTORS OFTEN TO PRESCRIBE THEM TO TREAT ANXIETY, SEIZURES, AND INSOMNIA. THE SHORT TERM USE OF THESE MEDICATION IS USUALLY SAFE AND EFFECTIVE BUT LONG TERM USE CAN LEAD TO TOLERANCE, DEPENDENCE, AND OTHER ADVERSE EFFECT.
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- 12. SITE OF ACTION • Midbrain- Wakefulness • Limbic system- Thought & mental functions • Medulla – Muscle Relaxation • Cerebellum – Ataxia Effect : Limbic system > midbrain RAS Therapeutic dose Anxiolytic > Sedative Higher dose Depress RAS Sedative effect and hypnotic effect 12
- 13. 13 Sedation (Sedatives) Sleep (hypnotics) Anesthesia Anesthetic Coma Death Dose Dependent Action
- 14. 14
- 16. 16 Mechanism of action Benzodiazepines I. Increase frequency of opening of cl- channels induced by GABA. II. Increase binding of GABA to GABA® receptor. III. Reduction of anxiety. Reduce anxiety by selectively enhancing GABAergic transmission in neurons having the α-2 subunit in their GABA® receptor. IV.The hypnotic effect are mediated by α1-GABA® receptor V. Anticonvulsant effect is partially although not completely, mediated by α1-GABA® receptors.
- 17. Pharmacokinetics 1. Slow elimination of parent drug & active metabolite. 2. Relatively slow elimination but marked redistribution. 3. Relatively slow elimination but marked redistribution. 4. Ultrarapid elimination 5. Lipophilic 17
- 18. SIDE EFFECTS OF SEDATIVES AND HYPNOTICS 1. Somnolence (drowsiness) 2. Headache 3. Asthenia (weakness) 4. Ataxia (impaired coordination, balance and speech) 5. Neuromuscular and skeletal weakness. 6. Hallucination 7. Dry mouth 8. Short- term forgetfulness
- 19. THANK YOU