it is a complete overview on ophthalmic dosage form. beginning from anatomy and physiology of eye with drug absorption mechanism including all factors to formulation considerations and evaluation of the products i.e. eye drops and eye ointment & the evaluation tests. it will help you make the concepts clear about ophthalmic drug deliveries.
A detailed study on every aspects of parenteral :- introduction, preformulation factors, essential requirements, vehicles and additives, isotonicity, production procedure, facilities, and controls, container and closure selection and finally the quality control evaluation of parenterals.
Ophthalmic dosage are the preparation designed for application to the eye:-
For treatment
For symptomatic release of symptoms
For diagnostic purpose
As aid to surgical procedures
They are the sterile products meant to instillation in to the eye in the space between eye lid and the eye ball
They are also prepared as parenteral product. Example
Eye drops, Eye lotion, Eye ointment, Eye suspension, Contact lens solution
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the types of containers and closure systems which are up to par with all the parameters defined by pharmacopoeias for parenterals.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Liquid oral topic in Industrial Pharmacy contains many topics like solution, elixirs, syrups, emulsion, and suspension. This topic includes general introduction, types, formulation, components, uses, and Quality control tests. These are also beneficial in other subjects like Pharmaceutics.
A detailed study on every aspects of parenteral :- introduction, preformulation factors, essential requirements, vehicles and additives, isotonicity, production procedure, facilities, and controls, container and closure selection and finally the quality control evaluation of parenterals.
Ophthalmic dosage are the preparation designed for application to the eye:-
For treatment
For symptomatic release of symptoms
For diagnostic purpose
As aid to surgical procedures
They are the sterile products meant to instillation in to the eye in the space between eye lid and the eye ball
They are also prepared as parenteral product. Example
Eye drops, Eye lotion, Eye ointment, Eye suspension, Contact lens solution
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the types of containers and closure systems which are up to par with all the parameters defined by pharmacopoeias for parenterals.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Liquid oral topic in Industrial Pharmacy contains many topics like solution, elixirs, syrups, emulsion, and suspension. This topic includes general introduction, types, formulation, components, uses, and Quality control tests. These are also beneficial in other subjects like Pharmaceutics.
Introduction to ophthalmic products useful as a basic & theoretical tool for pharmacy, medical & nursing students for their graduate and post graduate studies
In the area of topical ocular administration, important efforts concern the design and the conception of new ophthalmic drug delivery systems able to prolong the residence time.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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Pharynx and Clinical Correlations BY Dr.Rabia Inam Gandapore.pptx
Ophthalmic dosage form: eye drops & ointment
1.
2. Contents
Introduction
Anatomy and physiology of the eye
Mechanism of ocular absorption
Factors affecting intraocular bioavailability
Approaches to improve ocular drug delivery
Classification of ocular drug delivery systems
Eye drops
Eye ointment
3. Introduction
• Ophthalmic preparations are specialized dosage forms
designed to be instilled onto the external surface of the eye
(topical) or administered inside the eye (intraocular).
• The purpose may be therapeutic, prophylactic or palliative.
• The most commonly employed ophthalmic dosage forms
are solutions, suspensions, and ointments.
• The newest dosage forms for ophthalmic drug delivery are:
gels, gel-forming solutions, ocular inserts , intravitreal
injections and implants.
4. Anatomy & physiology of Eye
Human eye
Diameter 23 mm
Consist 3 layes-
1. Outermost coat :
The clear,
transparent cornea
and the white,
opaque sclera.
2. Middle layer :
The iris anteriorly,
the choroid
posteriorly, and
the ciliary body at
the intermediate
part.
3. Inner layer :
Retina (extension
of CNS).
5. The Cornea:
The cornea is transparent and allows light to enter the eye. It is a
powerful refracting surface, providing much of the eye's focusing
power.
Epithelium-stroma-endothelium (fat-water-fat structure).
Penetration of the drug depends on oil-water partition coefficient.
The sclera: The protective outer layer of the eye, referred to as the
“white of the eye” and it maintains the shape of the eye.
The choroids is the second layer of the eye and lies between the sclera
and the retina. It contains the blood vessels that provide nourishment to
the outer layers of the retina.
6. The iris is the part of the eye that gives it color. It consists of muscular
tissue that responds to surrounding light, making the pupil opening in the
center of the iris, larger or smaller depending on the brightness of the light.
The lens is a transparent, biconvex structure, encased in a thin transparent
covering. The function of the lens is to refract and focus incoming light
onto the retina.
The retina is the innermost layer in the eye. It converts images into
electrical impulses that are sent along the optic nerve to the brain where the
images are interpreted.
The macula is located in the back of the eye, in the center of the retina.
This area produces the sharpest vision.
7. The inside of the eyeball is divided by the lens into two fluid-filled
sections.
The larger section at the back of the eye is filled with a colorless
gelatinous mass called the vitreous humor.
The smaller section in the front contains a clear, water-like material
called aqueous humor.
The conjunctiva is a mucous membrane that begins at the edge of the
cornea and lines the inside surface of the eyelids and sclera, which
serves to lubricate the eye.
Lacrimal glands
Secrete tears & wash foreign bodies.
Moistens the cornea & prevent
from drying out. conjunctiva
8. Non-Corneal Absorption
Penetration across Sclera & Conjuctiva into Intra Ocular tissues
Non-Productive: because penetrated drug is
absorbed by general circulation
Corneal Absorption
Outer Epithelium: rate limiting barrier, with
pore size 60å, Only access to small ionic & lipohillic molecules.
Trans cellular transport: transport between corneal epithelium &
stroma.
Mechanism of ocular absorption
10. Factors affecting drug availability:
1. Rapid solution drainage by gravity, induced lachrymation, blinking
reflex, and normal tear turnover.
The normal volume of tear = 7 µl
The blinking eye can accommodate a volume of up to 30 µl without
spillage
The drop volume = 50 µl
2. Superficial absorption of drug into the conjunctiva and sclera and rapid
removal by the peripheral blood flow
11. 3. Low corneal permeability (act as lipid barrier)
In general:
-Transport of hydrophillic and macromolecular drugs occurs
through scleral route.
-Lipophillic agents of low molecular weight follow transcorneal
transport by passive diffusion.
4. Metabolism
Enzymatic biotransformation
Esterases, oxidoreductases, Peptidases, Glucuronide
Sulfate transferases, Lysosomal enzymes.
12.
13. 1. Viscosity enhancers
2. Eye ointments
3. Gel
4. Prodrug
5. Penetration enhancers
6. Liposomes
7. Niosomes
8. Nanosuspension
9. Microemulsion
10. Nanoparticles/nanospheres
11. In situ-forming gel
Approaches to improve ocular drug delivery
14. Enhancement of bioavailability
1. Increase in viscosity of formulation leads to decrease in drainage.
2. Slows elimination rate from the precorneal area and enhance contact
time.
3. Generally hydrophilic polymers, eg. Methyl cellulose, polyvinyl
alcohols, polyacrylic acids, sodium carboxy methyl cellulose,
carbomer are used.
4. A minimum viscosity of 20 cp is needed for optimum corneal
absorption.
15. Use of penetration enhancers
1. Substances which increases the permeability characteristics of the
cornea by modifying the integrity of corneal epithelium are known
as penetration enhancers.
2. Act by increasing corneal uptake by modifying the integrity of
the corneal epithelium.
Modes of actions
1. By increasing the permeability of the cell membrane.
2. Acting mainly on tight junctions.
e.g. dimetylsulfoxide(DMSO), laurocapram.
16. Prodrugs
1. Prodrugs enhance corneal drug permeability through modification
of the hydrophilicity or lipophilicity of the drug.
2. The method includes modification of chemical structure of the drug
molecule, thus making it selective, site specific and a safe ocular
drug delivery system.
3. Drugs with increased penetrability through prodrug formulations are
epinehrine, phenylephrine, timolol, pilocarpine.
17. USE OF MUCOADHESIVES IN OCULAR DRUG DELIVERY
Polymeric mucoadhesive vehicle: Retained in the eye due to
noncovalent bonding with conjuctival mucine.
Mucine is capable of picking of 40-80 times of weight of water.
Thus prolongs the residence time of drug in the conjuctival sac.
Mucoadhesives contain the dosage form which remains adhered to
cornea until the polymer is degraded or mucus replaces itself.
Types
1. Naturally Occurring Mucoadhesives - Lectins, Fibronectins
2. Synthetic Mucoadhesives - PVA, Carbopol, carboxy methyl
cellulose, cross-linked polyacrylic acid.
18. Phase Transition System
1. Solution that are liquid in the container and thus can be instilled as
eye drop becomes gel on contact with the tear fluid and provide
increased contact time with the possibility of improved drug
absorption and increased duration of therapeutic effect.
2. Liquid-gel phase transition-dependent delivery system vary according
to the particular polymer employed and their mechanism for
triggering the transition to a gel phase in the eye take advantage of
change in temperature, pH, ion sensitivity, or lysozymes upon
contact with tear fluid.
19. POLYMER MECHANISM
Lutrol FC – 127 and Poloxamer 407 Viscosity increases when their
temperature raises to eye
temperature.
Cellulose acetate phthalate latex Coagulates when its native pH 4.5
raised by tear fluid to pH 7.4
Gelrite Forms clear gel in the presence of
cations
Example of polymer
21. Ideal Ophthalmic Delivery System
Good corneal penetration.
Prolong contact time with corneal tissue.
Simplicity of instillation for the patient.
Non irritant and comfortable form.
Appropriate rheological properties.
Inert and stable.
22. Eye drops
Eye drops are sterile solutions, suspensions or emulsions intended for
instillation in the eye.
Solutions are Manufactured by dissolution of the active ingredients and
the excipients into all portion of water and sterilization of this solution
done.
If the drug is not sufficiently soluble, it can be formulated as a
suspension.
Topical ophthalmic emulsions generally are prepared by dissolving or
dispersing the active ingredient(s) into an oil phase, adding suitable
emulsifying agent and mixing with water vigorously to form a uniform
oil-in-water emulsion.
23. Ophthalmic products contains drugs of various categories
including –
Miotics e.g. Pilocarpine HCl
Mydriatics e.g. Atropine
Anti-inflammatories e.g. Corticosteroids
Anti-infectives (antibiotics, antivirals and antibacterials)
Anti-glucoma drugs e.g. Pilocarpine Hcl
Diagnostic drugs e.g. Sodium fluorescein
Anesthetics e.g. Tetracaine
formulation
24. Eye drop should be sterile and should contain
preservatives to avoid microbial contamination when
container is open.
•The preservative for ophthalmic use includes-
benzalkonium chloride
chlorbutanol
phenylmercuric acetate
phenylmercuric nitrate etc.
25. Eye drops are sterilized by autoclaving at 121°C for 15
minutes.
• Bacterial filters are used to avoid thermal degradation.
e.g.- preservative chlorbutanol hydrolyzes at high
temperature.
26. The order of surfactant toxicity is :
anionic > cationic >> nonionic .
• several nonionic surfactants are used in relatively low
Concentration to aid in dispersing steroids in suspensions
and to achieve or to improve solution clarity.
• Those principally used are the sorbitan ether esters of
oleic acid ( polysorbate or tween 20 and 80 ).
27. pH adjustment is very important as pH affects-
1- To render the formulation more stable
2- The comfort, safety and activity of the product.
Eye irritation
increase in tear fluid secretion
Rapid loss of medication.
3- To enhance aqueous solubility of the drug.
4- To enhance the drug bioavailability
5- To maximize preservative efficacy
Note: If buffers are required there capacity is controlled to be as low as possible
( low buffer capacity) thus enabling the tear to bring the pH of the eye back to the
physiological range .
28.
29. Lachrimal fluid is isotonic with blood having an isotonicity value
Corresponding to that of 0.9% NaCl solution
e.g. Mannitol, NaCl , KCl buffer.
30. Polyvinyl alcohol, methylcellulose, hydroxypropyl
methylcellulose, hydroxyethylcellulose, and carbomers,are
commonly used to increase the viscosity of solution and
suspensions (to retard the rate of setting of particles) They increase
the ocular contact time , there by decreasing the drainage rate,
increase the mucoadhesiveness and Increasing the bioavailability .
Disadvantage : produce blurring vision as when dry, form a dry
film on the eye lids. make filteration more difficult .
commercial viscous vehicles are :
1. polyvinyl alcohol (liquifilm)
2. hydroxypropyl methylcellulose (isopto)
31. Ophthalmic drop (using purifies water USP) as the solvent.
Purified water meeting USP standards may be obtained by :
Distillation, deionization, or reverse osmosis.
Oils have been used as vehicles for several topical eye drops
products that are extremely sensitive to moisture.
When oils are used as vehicles in ophthalmic fluids, they must
be of the highest purity.
Not for injection. For external use only. Shake well before use
(if it is suspension).
32. Administration:
-Pull down the eyelid.
-Tilting the head backwards.
-Look at the ceiling after the tip is pointed close to the lower cul-de-
sac.
-Apply a slight pressure to the rubber bulb
or plastic bottle to allow a drop to fall into
the eye.
-Do not squeeze lids.
To prevent contamination:
-Clean hands
-Do not touch the dropper tip to the eye and surrounding tissue
33. Eye drops have been packaged almost entirely in plastic dropper
bottles
The main advantage of the Drop-Trainer are:
- Convenience of use by the patient
- Decreased contamination potential
- Lower weight
- Lower cost
The plastic bottle and dispensing tip is made of low-density
polyethylene (LDPE) resin, which provides the necessary
flexibility and inertness.
The cap is made of harder resin than the bottle.
34. A special plastic ophthalmic package made of polypropylene is
introduced. The bottle is filled then sterilized by steam under
pressure at 121°C.
Powder for reconstitution use glass containers , owing to their
heat-transfer characteristics, which are necessary during the freeze-
drying processes.
The glass bottle is made sterile by dry-heat or steam autoclave
sterilization.
Amber glass is used for light-resistance.
35. Dosage form Advantages Disadvantages
Solutions 1. Convenience
2. Usually do not interfere
with vision of patient.
1. Rapid precorneal elimination.
2. Non sustained action.
3. To be Administered at frequent
intervals.
Suspension 1. Patient compliance.
2. Best for drug with slow
dissolution.
3. Longer contact time
1. Drug properties decide
performance loss of both
solutions and suspended
particles.
2. Irritation potential due to the
particle size of the drug.
Emulsion 1. Prolonged release of
drug from vehicle
1. Blurred vision.
Advantages and Disadvantages of Eye Drops
36. Prolongation of drug contact time with the external ocular
surface can be achieved using ophthalmic ointment vehicle.
The ointment base is sterilized by heat and appropriately
filtered while molten to remove foreign particulate matter.
The ointment base selected for an ophthalmic ointment must be
nonirritating to the eye and must permit the diffusion of the active
ingredient throughout the secretions bathing the eye.
EYE ointment
Ointment base is
sterilized by heat and
filtered while molten
to remove foreign
particulate matter.
It is then placed into a
sterile steam jacketed
to maintain the
ointment in a molten
state and excipients
are added
The entire ointment
may be passed
through a previously
sterilized colloid mill
37. Packaging:
Ophthalmic ointment are packaged in :
1.Small collapsible tin tube usually holding 3.5g of product. the pure tin
tube is compatible with a wide range of drugs in petrolatum-based
ointments.
2.Aluminum tubes have been used because of their lower cost and as an
alternative of tin.
3.Plastic tubes made from flexible LDPE resins have also been
considered as an packaging material.
•Filled tubes may be tested for leakers.
•The screw cap is made of polyethylene or polypropylene.
•The tube can be a source of metal particles and must be cleaned
carefully before sterilization (by autoclaving or ethylene oxide).
38. Advantages
1. Longer contact time and greater storage stability.
2. Flexibility in drug choice.
3. Improved drug stability.
Disadvantages
1. Sticking of eyes lids.
2. Blurred vision.
3. Poor patient compliance
4. Interfere with the attachment of new corneal epithelial cells to
their normal base.
5. Matting of eyelids
39. Evaluation of the ophthalmic product is done by
following tests:
1. Sterility Test
2. Clarity Test
3. Leakage Test
4. Metal particles in ophthalmic ointment
Evaluation tests
40. Sterility Tests :
Ophthalmic products should be free from anaerobic and aerobic
bacteria and fungi.
Sterility tests are therefore performed by the:
1. Membrane filtration method.
2. Direct - inoculation method.
In the Membrane filtration method :
• A solution of test product (1%) is prepared in isopropyl
myristate and allowed to penetrate through cellulose nitrate
filter with pore size 0.45 μ m.
• If necessary, gradual sunction or pressure is applied to aid
filtration.
41. The membrane is then washed three times with 100 - ml quantities
of sterile diluting and rinsing fluid and transferred aseptically into
fluid thioglycolate medium (FTM) and soybean – casein digest
medium (SBCD) .
The membrane is finally incubated for 14 days.
Growth on FTM indicates the presence of anaerobic and aerobic
bacteria.
Growth on Soybean casein digest medium indicates the presence of
fungi and aerobic bacteria.
Absence of any growth in both these media establishes the sterility
of the product.
42. In the Direct - inoculation technique :
1 part of the product is diluted with 10 parts of sterile diluting and
rinsing fluid with the help of an emulsifying agent .
Incubate in Fluid thioglycolate medium (FTM) and soybean –
casein digest (SCDM) media for 14 days .
In both techniques, the number of test articles is based on the batch
size of the product.
If the batch size is less than 200 the containers, either 5% of the
containers or 2 containers (whichever is greater) are used.
If the batch size is more than 200, 10 containers are used for
sterility testing .
43. Clarity is tested by visual inspection of containers under light and
against a black and white background.
Instrumental methods of evaluation is based on the principles of
light scattering, light absorption and electrical resistance which are
used to count particle and particle size distribution.
Unwanted mobile insoluble matter other than gas bubbles are
present in the given product are detected.
It may be dangerous when the particle size is larger than R.B.C.
and may block the blood vessel.
Clarity Test:
44. This test is mandatory for ophthalmic products, which evaluates
the intactness of the ointment tube and its seal.
Ten sealed containers are selected, and their exterior surfaces are
cleaned.
They are horizontally placed over absorbent blotting paper .
maintained at 60 ± 3 ° C for 8 h.
The test passes if leakage is not observed from any container.
If leakage is observed, the test is repeated with an additional 20
tubes.
The test passes if not more than 1 container shows leakage out of 30
tubes .
Leakage test :
45. This test is required only for ophthalmic ointments.
The presence of metal particles will irritate the corneal or
conjunctival surfaces of the eye.
It is performed using 10 ointment tubes.
The content from each tube is completely removed onto a clean
60 - mm - diameter Petri dish which possesses a flat bottom.
The lid is closed and the product is heated at 85 °C for 2 hours.
Once the product is melted and distributed uniformly, it is cooled
to room temperature.
The lid is removed after solidification.
The bottom surface is then viewed through an optical microscope
at 30× magnification.
Test for Metal Particles:
46. The viewing surface is illuminated using an external light source
positioned at 45 ° on the top.
The entire bottom surface of the ointment is examined, and the
number of particles 50 μm or above are counted using a calibrated
eyepiece micrometer.
The USP recommends that the number of such particles in 10
tubes should not exceed 50, with not more than 8 particles in any
individual tube.
Limits are not met, the test is repeated with an additional 20 tubes.
In this case, the total number of particles in 30 tubes should not
exceed 150, and not more than 3 tubes are allowed to contain more
than 8 particles, the test passes.
47. •Carter S.J., “Dispensing for pharmaceutical by Cooper
and gunn”, CBS Publisher. p.p.634-661
•Jain N.K., Gupta G.D. “Modern dispensing pharmacy”,
Published by Pharma book syndicate. p.p. 13.3-14.9
•Mithal B.M., “Text of pharmaceutical formulation”,
Vallabh prakashan. p.p. 268-278
•Felton L., “Remington’s essential of pharmaceutics”,
published by pharmaceutical press. p.p.541-562
References