Gastro retentive drug delivery system (GRDDS)Shweta Nehate
Oral route is the most acceptable route for drug administration. Apart from conventional dosage forms several other forms were developed in order to enhance the drug delivery for prolonged time period and for delivering drug to a particular target site. Gastro-retentive drug delivery system (GRDDS) has gainned immense popularity in the field of oral drug delivery recently. it is a widely employed approach to retain the dosage form in the stomach for an extended period of time and release the drug slowly that can address many challenges associated with conventional oral delivery, including poor bioavailability. different innovative approaches are being applied to fabricate GRDDS. Gastroretentive drug delivery is an approach to prolong gastric residence time, there by targeting site-specific drugs release in the upper gastrointestinal tract (GIT) for local or systemic effects. It is obtained by retaining dosage form into stomach and by releasing the in controlled manner.
Gastro retentive drug delivery system (GRDDS)Shweta Nehate
Oral route is the most acceptable route for drug administration. Apart from conventional dosage forms several other forms were developed in order to enhance the drug delivery for prolonged time period and for delivering drug to a particular target site. Gastro-retentive drug delivery system (GRDDS) has gainned immense popularity in the field of oral drug delivery recently. it is a widely employed approach to retain the dosage form in the stomach for an extended period of time and release the drug slowly that can address many challenges associated with conventional oral delivery, including poor bioavailability. different innovative approaches are being applied to fabricate GRDDS. Gastroretentive drug delivery is an approach to prolong gastric residence time, there by targeting site-specific drugs release in the upper gastrointestinal tract (GIT) for local or systemic effects. It is obtained by retaining dosage form into stomach and by releasing the in controlled manner.
Mucoadhesive drug delivery system interact with the mucus layer covering the mucosal epithelial surface, & mucin molecules & increase the residence time of the dosage form at the site of the absorption.
Mucoadhesive drug delivery system is a part of controlled delivery system.
Since the early 1980,the concept of Mucoadhesion has gained considerable interest in pharmaceutical technology.
combine mucoadhesive with enzyme inhibitory & penetration enhancer properties & improve the patient complaince.
MDDS have been devloped for buccal ,nasal,rectal &vaginal routes for both systemic & local effects.
Hydrophilic high mol. wt. such as peptides that cannot be administered & poor absorption ,then MDDS is best choice.
Mucoadhesiveinner layers called mucosa inner epithelial cell lining is covered with viscoelasticfluid
Composed of water and mucin.
Thickness varies from 40 μm to 300 μm
General composition of mucus
Water…………………………………..95%
Glycoproteinsand lipids……………..0.5-5%
Mineral salts……………………………1%
Free proteins…………………………..0.5-1%
The mechanism responsible in the formation of mucoadhesive bond
Step 1 : Wetting and swelling of the polymer(contact stage)
Step 2 : Interpenetration between the polymer chains and the mucosal membrane
Step 3 : Formation of bonds between the entangled chains (both known as consolidation stage)
Electronic theory
Wetting theory
Adsorption theory
Diffusion theory
Fracture theory
Advantages over other controlled oral controlled release systems by virtue of prolongation of residence of drug in GIT.
Targeting & localization of the dosage form at a specific site
-Painless administration.
-Low enzymatic activity & avoid of first pass metabolism
If MDDS are adhere too tightlgy because it is undesirable to exert too much force to remove the formulation after use,otherwise the mucosa could be injured.
-Some patient suffers unpleasent feeling.
-Unfortunately ,the lack of standardized techniques often leads to unclear results.
-costly drug delivery system
Methods For Assesment Of Bioavailability Anindya Jana
Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
Bioavailability studies are important in the Primary stages of development of a suitable dosage form for a new drug entity, determination of influence of excipients, patient related factors & possible interaction with other drugs on the efficiency of absorption, development of new formulations of the existing drugs, control of quality of a drug product during the early stages of marketing in order to determine the influence of processing factors, storage & stability on drug absorption
FORMULATION AND EVALUATION OF OCUSERTS OF CIPROFLOXACIN HClMohammad Adil
Conventional ocular drug delivery system i.e., eye drops, ointments, gels etc., had become less popular pertaining to their disadvantages like evaporation by tears, pre-corneal loss, drug metabolism, drug-protein interaction, drainage, sticking of eye lids, induced lacrimation, poor patient compliance, systemic side effect and blurred vision etc. That’s why fundamentals of controlled release by means of ocular inserts were utilized to increase problem pre-corneal drug residence time.
This project title “Formulation and Evaluation of Ocuserts of Ciprofloxacin HCl” revealed following results:
Compatibility study using FTIR was performed to check the compatibility of drug with various excipient. Characteristics peaks obtained with pure drug were compared with that produced with different excipients that confirmed the compatibility of drug with excipients.
Ocusert of Ciprofloxacin HCl was prepared using different material i.e., PVP K-30, PVA, PEG 400 and glycerin.
Prepared ocuserts were evaluated for various parameters viz., percentage moisture loss, percentage moisture absorbs, thickness, weight variation, drug content and In-vitro diffusion.
The percentage (%) moisture absorption and loss of ocular insert were found to be 26% and 27% respectively.
The thickness of ocular insert was found to be uniformed and its mean while measuring at different points was found to be 0.124mm.
The weight of ocular inserts was found to be in the range of 12.2 - 12.6mg which indicated decent distribution of the drug, polymer and plasticizer.
The drug content of ocular insert was found to be 99.89%.
Percentage drug release from Ciprofloxacin HCl Ocusert was found to be 41.969% in 8 hr.
It was concluded that prepared Ocusert of Ciprofloxacin HCl could be a better alternative to conventional ocular formulations that retained on ocular surface for longer duration and released drug in controlled manner.
Video Lecture is available at https://www.youtube.com/watch?v=DXu_CLgB4q0
Introduction, terminology/definitions and rationale, advantages, disadvantages, selection of drug candidates. Approaches to design-controlled release formulations based on diffusion, dissolution and ion exchange principles. Physicochemical and
biological properties of drugs relevant to controlled release formulations.
The device which is used in the intrauterine drug delivery system is known as an Intrauterine device (IUD) (2). IUDs or intrauterine devices are small artificial objects or devices inserted into the uterus to prevent the occurrence of pregnancy by disrupting the fertilization process as a result of sexual intercourse. They have gained popularity in recent times and are one of the most effective methods of birth control in terms of long-term contraception. It can be easily installed and is flexible. These devices are usually small in size and inserted through the cervix. IUDs reduce the need for abortion with unwanted pregnancies by preventing the effective movement of eggs and sperm. However, it cannot confirm the spread of STIs or STDs such as HIV, gonorrhoea, etc
Topics covered
Introduction
Advantages
Disadvantages
Development of intra uterine devices (IUDs)
Applications
References
The role of chronopharmacology in therapeutics drinjetiInjeti Prabhakar
Many drugs are still given without regard to the time of day
Identification of rhythmic marker for selecting dosing time will lead to progress of chronopharmacotherapy.
To monitor rhythmic markers such as clock genes it may be useful to choose the most appropriate time of day for administration of drugs that may increase their therapeutic effects and reduce their side effects .
To produce new rhythmicity by manipulating the conditions of living organs by using rhythmic administration of altered feeding schedules for several drugs appears to lead to a new concept of chronopharmacotherapy
Mucoadhesive drug delivery system interact with the mucus layer covering the mucosal epithelial surface, & mucin molecules & increase the residence time of the dosage form at the site of the absorption.
Mucoadhesive drug delivery system is a part of controlled delivery system.
Since the early 1980,the concept of Mucoadhesion has gained considerable interest in pharmaceutical technology.
combine mucoadhesive with enzyme inhibitory & penetration enhancer properties & improve the patient complaince.
MDDS have been devloped for buccal ,nasal,rectal &vaginal routes for both systemic & local effects.
Hydrophilic high mol. wt. such as peptides that cannot be administered & poor absorption ,then MDDS is best choice.
Mucoadhesiveinner layers called mucosa inner epithelial cell lining is covered with viscoelasticfluid
Composed of water and mucin.
Thickness varies from 40 μm to 300 μm
General composition of mucus
Water…………………………………..95%
Glycoproteinsand lipids……………..0.5-5%
Mineral salts……………………………1%
Free proteins…………………………..0.5-1%
The mechanism responsible in the formation of mucoadhesive bond
Step 1 : Wetting and swelling of the polymer(contact stage)
Step 2 : Interpenetration between the polymer chains and the mucosal membrane
Step 3 : Formation of bonds between the entangled chains (both known as consolidation stage)
Electronic theory
Wetting theory
Adsorption theory
Diffusion theory
Fracture theory
Advantages over other controlled oral controlled release systems by virtue of prolongation of residence of drug in GIT.
Targeting & localization of the dosage form at a specific site
-Painless administration.
-Low enzymatic activity & avoid of first pass metabolism
If MDDS are adhere too tightlgy because it is undesirable to exert too much force to remove the formulation after use,otherwise the mucosa could be injured.
-Some patient suffers unpleasent feeling.
-Unfortunately ,the lack of standardized techniques often leads to unclear results.
-costly drug delivery system
Methods For Assesment Of Bioavailability Anindya Jana
Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
Bioavailability studies are important in the Primary stages of development of a suitable dosage form for a new drug entity, determination of influence of excipients, patient related factors & possible interaction with other drugs on the efficiency of absorption, development of new formulations of the existing drugs, control of quality of a drug product during the early stages of marketing in order to determine the influence of processing factors, storage & stability on drug absorption
FORMULATION AND EVALUATION OF OCUSERTS OF CIPROFLOXACIN HClMohammad Adil
Conventional ocular drug delivery system i.e., eye drops, ointments, gels etc., had become less popular pertaining to their disadvantages like evaporation by tears, pre-corneal loss, drug metabolism, drug-protein interaction, drainage, sticking of eye lids, induced lacrimation, poor patient compliance, systemic side effect and blurred vision etc. That’s why fundamentals of controlled release by means of ocular inserts were utilized to increase problem pre-corneal drug residence time.
This project title “Formulation and Evaluation of Ocuserts of Ciprofloxacin HCl” revealed following results:
Compatibility study using FTIR was performed to check the compatibility of drug with various excipient. Characteristics peaks obtained with pure drug were compared with that produced with different excipients that confirmed the compatibility of drug with excipients.
Ocusert of Ciprofloxacin HCl was prepared using different material i.e., PVP K-30, PVA, PEG 400 and glycerin.
Prepared ocuserts were evaluated for various parameters viz., percentage moisture loss, percentage moisture absorbs, thickness, weight variation, drug content and In-vitro diffusion.
The percentage (%) moisture absorption and loss of ocular insert were found to be 26% and 27% respectively.
The thickness of ocular insert was found to be uniformed and its mean while measuring at different points was found to be 0.124mm.
The weight of ocular inserts was found to be in the range of 12.2 - 12.6mg which indicated decent distribution of the drug, polymer and plasticizer.
The drug content of ocular insert was found to be 99.89%.
Percentage drug release from Ciprofloxacin HCl Ocusert was found to be 41.969% in 8 hr.
It was concluded that prepared Ocusert of Ciprofloxacin HCl could be a better alternative to conventional ocular formulations that retained on ocular surface for longer duration and released drug in controlled manner.
Video Lecture is available at https://www.youtube.com/watch?v=DXu_CLgB4q0
Introduction, terminology/definitions and rationale, advantages, disadvantages, selection of drug candidates. Approaches to design-controlled release formulations based on diffusion, dissolution and ion exchange principles. Physicochemical and
biological properties of drugs relevant to controlled release formulations.
The device which is used in the intrauterine drug delivery system is known as an Intrauterine device (IUD) (2). IUDs or intrauterine devices are small artificial objects or devices inserted into the uterus to prevent the occurrence of pregnancy by disrupting the fertilization process as a result of sexual intercourse. They have gained popularity in recent times and are one of the most effective methods of birth control in terms of long-term contraception. It can be easily installed and is flexible. These devices are usually small in size and inserted through the cervix. IUDs reduce the need for abortion with unwanted pregnancies by preventing the effective movement of eggs and sperm. However, it cannot confirm the spread of STIs or STDs such as HIV, gonorrhoea, etc
Topics covered
Introduction
Advantages
Disadvantages
Development of intra uterine devices (IUDs)
Applications
References
The role of chronopharmacology in therapeutics drinjetiInjeti Prabhakar
Many drugs are still given without regard to the time of day
Identification of rhythmic marker for selecting dosing time will lead to progress of chronopharmacotherapy.
To monitor rhythmic markers such as clock genes it may be useful to choose the most appropriate time of day for administration of drugs that may increase their therapeutic effects and reduce their side effects .
To produce new rhythmicity by manipulating the conditions of living organs by using rhythmic administration of altered feeding schedules for several drugs appears to lead to a new concept of chronopharmacotherapy
Evaluating the cost to benefit ratio of a Drug Delivery platformBhaswat Chakraborty
This talk calls for a tall order of understanding of the patient needs, techno-innovative and economic aspects of drug delivery platform technologies and in turn making sound decisions in research & development, administration and policy making. In general, therapeutic effect of a drug is determined by its potency as well as by the efficiency of its delivery to the site of action. Thus, therapeutic effects of many drugs are improved and controlled through the use of appropriate new drug delivery systems (NDDS). Often this advantage is associated with the added benefit of improved side effects and patient compliance for most NDDS. NDDS cover a wide range of technologies and routes of administration, such as oral, buccal-mucosal, ophthalmic, transdermal, pulmonary and colonic – to name a few.
Understanding the key patient needs and the resolve of devising the best delivery formulations have revolutionized the platform technologies. For example, in oral modified release (MR) technology, the key need is to optimize bioavailability with much fewer dosing frequency, whereas in ophthalmic MRs, the principal requirements are absence of local toxicity, tolerance, ease of dispensing, sterility, and osmolarity, etc. In this context, therapeutic categories are very relevant (e.g., the challenges and accuracy in technology development in ophthalmic preparation are steeper than oral preparations). For pulmonary delivery systems, the release of the drug in pulmonary tract is more important and beneficial for the patients than controlling the delivery. Similarly, achieving high local concentrations is the main goal in colonic and vaginal technologies.
Economic values or improvement in benefit-cost ratio in NDDS come not only from better addressing patient needs (efficacy enhancement, reduced dosing and side effects etc.) and compliance. Economic benefits are explicit in patent extension, increased market share and decreased costs). These benefits are obvious. Subtle and non-obvious benefits become apparent upon thorough cost effectiveness and cost utility analysis of many NDDS technologies. The speaker will give a few examples of substantial gains in quality adjusted life years when a drug was delivered through a delivery technology.
Frontiers in Neurology is led by Field Chief Editor Jose Biller from the Loyola University Medical Center and 35 Specialty Chief Editors. Over 3,300 leading researchers and clinicians serve on the editorial boards that span 25 specialty research areas ranging from Neurotrauma and Brain Imaging methods to Neuro-Oncology, stroke, and teleneurology.
Day and Night in Building Science and Chronobiology: How the buildings we inhabit could take advantage of daylight—both to keep human occupants comfortable and healthy, and also to optimize energy efficiency. The third event in our series on light.
Natural light helps keep our bodies in tune with the external cycle of day and night, the so-called circadian system, and therefore with the world around us. For many, sunlight is a cue to wake, while darkness leads us toward sleep.
It is important, then, that the buildings we inhabit take full advantage of daylight—both to keep human occupants comfortable and healthy, and also to optimize energy efficiency.
For the third event in our series on light, swissnex San Francisco brings Jean-Louis Scartezzini and Mirjam Münch, from the Solar Energy and Building Physics Laboratory at EPFL, to present their experiences with daylighting research and technology. Their work illustrates possible integration steps toward optimized “Day and Night” lighting environments with respect to energy consumption and human health.
Marilyne Andersen, associate professor in the Building Technology Program of MIT’s Department of Architecture and head of the Daylighting Lab, also joins the discussion with an overview of her efforts to better integrate energy-efficiency and human-responsiveness to daylighting into architecture and design.
All behavior patterns are co-ordinated sequences of neuromuscular activity. A rhythm is a periodically recurring event.
chronobiology is the study of science of life in relation with time.
The majority of organisms show daily and annual cycles of activity and development.
Formulation and evaluation of modified drug release tablet in tablet dosage w...SriramNagarajan16
Controlled drug dosage forms offer many advantages, such as nearly constant drug level at the site of action,
prevention of peak-valley fluctuation, reduction in dose of drug, reduced dosage frequency, avoidance of side effects
and improved patient compliance. Hence an attempt has been made to develop modified drug release by using tablet in
tablet technique with barrier coating by using natural and synthetic polymers with Salbutamol as model drug. The inner
core tablets were prepared by using direct compression method. The formulation F7 was selected for press coat by using
different polymers like HPMC, Ethyl cellulose, Xanthum gum and Guar gum in different ratios among which 1part of
Xanthum gum and 1part of Guar gum was optimized based on the lag time (20.75% in 4 hours) and percent of drug
release and also further evaluated.
CHRONOTHERAPEUTICS: A NEW VISTA IN NOVEL DRUG DELIVERY SYSTEMSSarvan Mani
Chronotherapeutics is the delivery of medications in the
right concentration to the right targeted tissues at the
right time to meet biological rhythm-determined needs,
e.g., rhythms in the mechanisms of disease, symptom
intensity, and/ or patient tolerance, to optimize desired
and minimize and avert adverse effects.
Chronobiology is a field of biology that examines periodic phenomena in living organisms and their adaptation to solar- and lunar-related rhythms.
These cycles are known as biological rhythms.
Chronobiology comes from the ancient Greek word (chrónos, meaning "time"), and biology, which pertains to the study, or science, of life.
Chronobiology is the science of biological rhythms, more specifically the impact of the 24- hour light- dark cycle on our biochemistry and therefore behaviors.
It is defined as the periodic component of temporal series of biological data whose waveform profile has been analytically validated.
In other words, biological rhythm is a bio-signal whose period of oscillation has been validated by analytical models of periodic regression using one or more harmonic components.
Examples : Heart beat, breathing, hormone secretion, menstrual cycle, body temperature and sleep/wake cycle.
Introduction to chronology, chronotherapy, and chronopharmacology.
How chronopharmacology involved in asthma and helps to manage asthma?.
Biological rhythms in bronchial asthma.
Factors associated with nocturnal exacerbation of bronchial asthma.
Introduction to asthma and their symptoms.
Introduction to Antiasthmatic drugs like beta-blockers, leukotriene antagonists, steroids, etc.
Chronopharmacology division & their examples.
Advantages and disadvantages of chronopharmacology.
Marketed preparation and their images along with the price in India.
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
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Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
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"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
Digital Transformation and IT Strategy Toolkit and TemplatesAurelien Domont, MBA
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VAT Registration Outlined In UAE: Benefits and Requirementsuae taxgpt
Vat Registration is a legal obligation for businesses meeting the threshold requirement, helping companies avoid fines and ramifications. Contact now!
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Falcon stands out as a top-tier P2P Invoice Discounting platform in India, bridging esteemed blue-chip companies and eager investors. Our goal is to transform the investment landscape in India by establishing a comprehensive destination for borrowers and investors with diverse profiles and needs, all while minimizing risk. What sets Falcon apart is the elimination of intermediaries such as commercial banks and depository institutions, allowing investors to enjoy higher yields.
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What are the main advantages of using HR recruiter services.pdfHumanResourceDimensi1
HR recruiter services offer top talents to companies according to their specific needs. They handle all recruitment tasks from job posting to onboarding and help companies concentrate on their business growth. With their expertise and years of experience, they streamline the hiring process and save time and resources for the company.
Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
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Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
Kseniya Leshchenko: Shared development support service model as the way to ma...Lviv Startup Club
Kseniya Leshchenko: Shared development support service model as the way to make small projects with small budgets profitable for the company (UA)
Kyiv PMDay 2024 Summer
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Kseniya Leshchenko: Shared development support service model as the way to ma...
Chronopharmaceutics : A relevant approach to drug delivery
1. CHRONOPHARMACEUTICS: RELEVANT
APPROACH TO DRUG DELIVERY
Presented by
Gurubas T. Shelke
M. Pharm Sem-1
Pharmaceutics
Guided By
Mrs. Shilpa Shotriya
Email ID-gurushelke356@gmail.com
2. CONTENTS
Introduction
Circadian rhythm
Disease with established circadian rhythms
Modeling approach different disease
Design and developmentChronopharmaceutical drug
delivery system
Hurdles in chronopharmaceutical drug research and
development
4. INTRODUCTION
Chronopharmaceutics is a branch of pharmaceutics devoted to
the design and evaluation of drug delivery systems that release
a bioactive agent at a rhythm that ideally matches the biological
requirement of a given disease therapy.
Includes the fundamentals and research into various aspects of
chronophysiology, chronopathology, chronogenetics, chronoph
armacology, chronopharmacokinetics, chronopharmacodynami
cs, chronotherapeutics, and chronotoxicology.
5. Cont…
Combination of chronobiology and pharmaceutics
To release a drug at a rhythm to match the biological
requirement for a given disease therapy
To design and evaluate ChrDDS
To improve of therapeutic efficacy and patient-compliance.
Chronobiology : Study of biological rhythm and mechanism
in biological system
6. Circadian rhythm
Human biological functions are represented on a 24-hour
clock, called circadian rhythm
Related to the sleep-wake cycle
It can alter the sleep-wake cycles, hormone release, body
temperature and other biochemical, phsiological process
7. Circadian rhythm influences on physiological
process
Physiological functions Changes
Body temperature Sleep ↓ wakefulness ↑
Breathing Sleep Sleep ↓ wakefulness ↑
Blood pressure Sleep ↓ wakefulness ↑
Growth hormone pm 11:00 secretion ↑
Adrenaline pm 11:00 secretion ↑
Heart rate Sleep ↓ wakefulness ↑
Plasma catecholamines Increase in morning
Plasma aggregability Increase in morning
Fibrinolytic activity Decrease in morning
Gastric acid secretion Highest in evening
Gastric emptying More rapid in morning
8. Disease with established circadian rhythms
Fig1.24 h clock diagram of the approximate time, in human following the diurnal activity/nocturnal
sleep routine, when symptoms or events of diseases are worst or most frequent
9. Cont….
Fig2: The day/night patterns of disease severity.
10. Diseases
Asthma :
1.airway resistance increases progressively at night
2.lung function reaches at low pt in the early morning
3. Because of bronchoconstriction and exacerbation
symptom vary in circadian fashion
4. Chronotherapies have been studied for asthma
with oral corticosteroids, theophylline,and β2 agonist
Arthritis:
1.Circadian rhythm in the plasma concentration of c-reactive
protein and interleukin-6 of patients with rheumatoid arhritis
2. Chronotherapy for NSAID’s studied
11. Cont..
Duodenal ulcer
1.gastric acid secretion is highest during the night.
2.Histamine blockers are developed by ChrDDS
Cancer:
Blood flow to tumors and tumor growth rate are each up to threefold
greater during each daily activity phase of the circadian cycle than
during the daily rest phase
12. Modeling approach for different disease:
Modeling cardiovascular
diseases :
1.linear models
2.nonlinear model
3.multiple linear models
Harmonic regression equations
for the frequency of onset of
myocardial infarction according
to plasma creatine -kinase MB = number of myocardial infarctions
(CK-MB) activity per hour
t = time of day in hour
13. Modeling cancer chemotherapy
Two major models: Differential equation of each cell cycle
1. lumped parameter models
(e.g. Gompertz model):
Describe tumour growth
Diff. tumour type
Behavior heterogeneity
2. Cellcycle models
Xi: number of cells in a particular stage is
Describe cancer tumor behavior Ti: transition rate between stages
based on the number of cells in di: death rate for cells in a particular stage
r : enter the resting stage
a given phase of the cell cycle (1-r): return to the RNA/protein synthesis
stage
14. Modeling glucose insulin interaction
To estimate
glucose and
insulin in diabetic
patient G(t),: plasma glucose,I(t): plasma insulin
X(t): insulin concentration in a remote
compartment
E(t): exogenous insulin, Pi: parameters,
Gb: Basal glucose concentration
15. Modeling other diseases
Biochemical marker require for other diseaes
f(t): pharmacokinetic/pharmacodynamic (PK/PD)
M: mesor (midline,value about which oscillation
occur)
A: amplitude (half the difference between the
highest and lowest values)
w: the angular frequency
18. Hurdles in ChrDDS
1. Rhythmic biomaterials and system design
Biomaterial would biocompatible or biodegradable
overcome by microchip based drug delivery system, nanofabrication
biomaterial responsive to light , temparature ,pH,
2. Rhythm engineering and modeling
models required to elucidate the biological rhythm
age-structured partial differential equation (PDE) with time-periodic
coefficients was used to compare the growth rate of the models
3. Regulatory guidance related to these types of modified dosage
forms:
bioavailability requirements for CR products are covered in the US
Code of Federal Regulations under 21 CFR 320.25
IR formulation of the same drug ingredient or activemoiety, are covered
under 21 CFR 314.54
19. Chronopharmaceutical technologies:
1. CONTIN technology
2. Physico-chemical modification of the API
3. OROS technology
4. CODAS technology
5. CEFORM technology
6. DIFFUCAPS technology
7. Chronomodulating infusion pumps
8. TIMERx technology
9. Other CR erodible polymers
10. Controlled-release microchip
20. CONTIN technology
1.Complex formed between cellulose polymer and
non polar solid aliphatic alcohol which act as
amatrix
2.Used for aminophylline,theophylline,
morphine
3. Uniphyl(anhydrous theoforphylline) for
astmatic patient broncoconstriction incresed
4. More effective controll of disease and redues
unwanted side effects
21. OROS technology
OROS Delayed Push–
Pullk System, also known
as controlled onset
extendedrelease (COER)
To design Covera HSR, a
novel anti-hypertensive
product
Overnight release of Fig. Outline of the COER-24/OROS
verapamil delivery system:
(a) drug formulation, (b) swelling
To control BP early in the polymeric compartment, (c) hydrophilic
morning polymeric coating, (d) osmotic membrane
and (e) laser-drilled orifices.
22. Physico-chemical modification of the API
Physicochemical properties (e.g. solubility, partition
coefficient, membrane permeability, etc) altered
Solubility and permeability are critical factors governing
drug bioavailability
Ex. 1.Antihyperlipidemic statins (HMG-CoA reductase
inhibitors) Introduction of methyl group in lovastatin
produces simvastatin results in increase in Tmax from 2
to 4 hr
23. CODAS technology
The Chronotherapeutic Oral Drug Absorption System
(CODASR) is a multiparticular system.
To designed for bedtime drug dosing, incorporating a
4–5 h delay in drug delivery
Introduced by the non-enteric release-controlling
polymer applied to drug loaded beads
Ex. CODAS-verapamil extended release capsules
(Verelan PM)
24. CEFORM technology
Production of uniformly sized and shaped microspheres
Based on melt- spinning
To subject solid feedstock i.e. biodegradable
polymer/bioactive agents combinations to the combination
of temperature,thermal gradients, mechanical forces, flow,
and flow rates during processing
25. Cont..
Microsphere produced spherical of diameter 150–180 µm
Microspheres used in a wide variety of dosage forms,
including tablets, capsules, suspensions, effervescent
tablets, and sachets
Ex Cardizem LA, 1-day diltiazem formulation as ChrDDS
26. Chronomodulating infusion pumps
Include pre-programed system as well as system sensitive
to magnetic fields, ultrasound, electric fields, temperature,
light and mechanical stimulation
Infusion pump in the market:
1. Melodie
2. Programmable Synchromed
3. Panomat V5 infusion
4.The Rhythmic pumps
Ex. Insulin therapy
27. TIMERx technology
combines primarily xanthan and locust bean gums mixed
with dextrose
Drug release from TIMERx:
Water penetration from Gi to
TIMERx gum matrix
Expand to form agel
Active drug substance released
Ex. oral CR opioid analgesic oxymorphone
28. Three-dimensional printing
A novel technique based on solid free form fabrication
methods.
Basis of the TheriForm R technology
Complex oral drug delivery devices have been fabricated
using the 3DP process :-
1.Immediate-extended release tablets,
2.Pulse release,
3.Breakaway tablets, and
4.Dual pulsatory tablets.
29. CR erodible polymers
Erodable polymer designed for different formulation:
1.tablets
2.capsules
3.microparticles
Insoluble excipient Gel forming excipient
(e.g. dibasic calcium (e.g.Hydroxypropylmethy-
phosphate) lcellulose)
Erodible Tablet
30. Controlled-release microchip
Produced by microfabrication technology
Solid-state silicon microchip :- Provide controlled
release of single or multiple chemical substances on
demand.
Release mechanism : electrochemical dissolution of thin
anode membranes
Microreservoirs filled with chemicals in solid, liquid or
gel form
31. Chronopharmacodynamics
At the cellular and subcellular level biological rhythm can
give rise to significant dosing-time differences ths
phenomenon called as chronesthesy
Rhythms in receptor number or conformation,
second messengers,
metabolic pathways,and/or
free-to-bound fraction of medications
impt in chronopharmacodynamic
32. Cont…
Ex.1. antitumor effect of IFN-β and the antiviral effect of
IFN-α in more efficient during the early rest phase than
during the early active phase
2.Imatinib mesylate inhibit the tyrosine kinase acts on
receptor Abl, the bcr-abl chimeric product,
KIT, PDGF receptors
Efficacy of imatinib is more when PDGF receptor
activity is more
34. MARKETED DRUGS
FDA approval API Propriatory Chronopharmaceuti Indication
date name; cal tchnology
dosage form
Sept. 01, 1982 Theophylline Uniphyl CONTIN ASTHMA
Oct. 15, 1986 Famotidine PepcidR; Physico-chemical Ulcer
tablets modification of API
Dec. 23, 1991 Simvastatin ZocorR; Tablets Physico-chemical Hypercholest
modification of API erolemia
Feb. 26, 1996 Verapamil HCl Covera-HSR OROS Hypertension
Tablet
Nov. 25, 1998 Verapamil HCl VerelanRPM; CODAS Hypertension
Capsule
Feb. 06, 2003 Diltiazem HCl CardizemR LA; CEFORM Hypertension
verapamil HCl Tablet
Mar. 12, 2003 Propranolol HCl InnoPranR XL DIFFUCAPS Hypertension
verapamil HCl Capsule
35. MARKETED DRUGS IN JAPAN
API Proprietary name Chronopharmaceutical Disease
dosages form technology
Famotidine Gaster® tablets Physico-chemical Ulcer
modification of API
Simvastatin Lipovas® Physico-chemical Hyperlipidemia
tablets modification of API
Theophylline Uniphyl® CONTIN® Asthma
extended release
tablets
Tulobuterol Hokunalin® Transdermal chronodelivery Asthma
tape system
36. Conclusion
Chronopharmaceutics will certainly improve patient
outcome and optimize disease management in the future
Selection of the appropriate chronopharmaceutical
technology should take into considerations the application
range (e.g. targeted drugs of different physico-chemical
properties), the ease of manufacturing, the cost-
effectiveness, and the flexibility in the pharmacokinetic
profile
37. Cont…
Major drawback of existing oral ChrDDS on the market it
depend on human action to trigger the drug administration
for example on daily basis
Ideal ChrDDS should be self regulating, in future it may
possible to develop Ideal ChrDDS when taken any time of
the day and should take environmental factors in account
(e.g. awake–sleep, light–dark, activity–rest status)
38. References
1.Bi-Botti C. Youan* Chronopharmaceutics: new approach,
Journal of Controlled Release 98 (2004) 337– 353
2. S. Leslie, in: Euroceltique, SA, United States, 1982, p. 20
3. W. Hoffman, R. Smith, A. Willard, in: Merck & Co.,
United States, 1984, p. 26.
4. FDA, in: Electronic Orange Book (Administration, F. a.
D.,Ed.), Electronic Orange Book, Washington, DC, 2003
5. S. Leslie, The Contin delivery system: dosing
considerations J. Allergy Clin. Immunol. 78 (1986) 768–
773
39. Cont..
6. Bi-Botti C. Youan, Chronopharmaceutical drug delivery
systems: Hurdles, hype or hope? Advanced Drug Delivery
Reviews 62 (2010) 898–903
7. Shigehiro Ohdo, Chronotherapeutic strategy: Rhythm
monitoring, manipulation and disruption; Advanced Drug
Delivery Reviews 62 (2010) 859–875
8. Asim Sattwa Mandal, Nikhil Biswas, Kazi Masud
Karim, Arijit Guha, Sugata Chatterjee,Mamata
Behera, Ketousetuo Kuotsu, Drug delivery system based
on chronobiology—A review; Journal of Controlled
Release 147 (2010) 314–325