Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
Parenterals are the sterile preparation that is directly administered into the circulatory system avoiding the enteral route. And these preparation provide rapid onset of action that is why the administered preparation must be safe.
Stability problem arise from microbial contamination of these products so sterility and stability must be ensured for these preparations.
To ensure their sterility and stability, regulations regarding to quality control through pharmacopeial specifications has great importance.
At Aseptic Technologies we developed and manufacture innovative solutions for aseptic filling operations. Our equipment and devices are designed to provide safer & easier sterility assurance for aseptic fill and finish of biologicals, potent drugs and products requiring cryopreservation.
Parenterals are the sterile preparation that is directly administered into the circulatory system avoiding the enteral route. And these preparation provide rapid onset of action that is why the administered preparation must be safe.
Stability problem arise from microbial contamination of these products so sterility and stability must be ensured for these preparations.
To ensure their sterility and stability, regulations regarding to quality control through pharmacopeial specifications has great importance.
At Aseptic Technologies we developed and manufacture innovative solutions for aseptic filling operations. Our equipment and devices are designed to provide safer & easier sterility assurance for aseptic fill and finish of biologicals, potent drugs and products requiring cryopreservation.
A Transfersome carrier is an artificial vesicle or a cell engaged in exocytosis, and thus suitable for controlled and, potentially targeted drug delivery,.
“Emulsion of emulsion”, “double or triple emulsion”
Dispersed phase contain smaller droplets that have the same composition as the external phase.
Liquid film which separate the liquid phases acts as a thin semi permeable film through which solute must diffuse in order to travel from one phase to another – “Liquid Membrane System”
Two types: -
Oil-in-water-in-oil (O/W/O) emulsion system.
Water-in-oil-in-water (W/O/W) emulsion system.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
The President notified the creation of the Department of Health Research under the Ministry of Health & Family Welfare through an amendment to the Government of India (Allocation of Business) Rules, 1961 on the 17th September , 2007 The Department of Health Research was formally launched on 5th October 2007 by the Minister for Science & Technology and Earth Sciences in a function presided over by the Minister for Health & Family Welfare, in the presence, inter-alia, of the Minister of State for Health & Family Welfare.
After the manufacturing of the drug, it is essential that these should be stored properly. The stability of drug during it’s storage depend on so many factor and proper packaging is one of them. The pharmaceutical products are in direct contact with the container and closures. So improper packaging and poor quality of container may lead to deterioration of the product.
Sterile filtration of complex injectables by Partha BanerjeeMerck Life Sciences
Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies.
As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable.
Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
Sterile filtration of complex injectables by Partha BanerjeeMerck Life Sciences
Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies.
As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable.
Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
Sterile filtration of complex injectables by Partha BanerjeeMilliporeSigma
Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies.
As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable.
Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
Formulation and Evaluation of Fast Disintegrating Tablet of Solid Dispersion ...ijtsrd
The aim of the present work is Formulation and Evaluation of Fast Disintegrating Tablet of Solid Dispersion of Carvedilol. The solid dispersions of Carvedilol were prepared with PEG6000 and PVP K30 in 1 1, 1 2, 1 3 by using Kneading method. The prepared solid dispersions were analyzed for FTIR. Solid dispersions showed a better dissolution compared to the pure drugs and among all the other formulations. The F3 formulation shows high percentage drug release i.e. 96.61 in 40 min and selected as an optimized formulation for the preparation of fast disintegrating tablets of Carvedilol. Crosscarmellose sodium and Crospovidone used in the preparation of fast disintegrating tablets prepared by direct compression method. The post compression parameters of all the prepared tablets were within the limits. FD6 was selected as optimized formulation based on its highest disintegration time 48 sec and drug release 94.87 in 40 min. Hence it concluded that solid dispersions incorporated fast disintegrating tablets is very useful approach for fast disintegration of Carvedilol to treat high blood pressure. Akshada Gavhane | Prof. Mr. Prashant Khade | Dr. Ashok Bhosale "Formulation and Evaluation of Fast Disintegrating Tablet of Solid Dispersion of Carvedilol - A Research" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-5 , August 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50379.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/50379/formulation-and-evaluation-of-fast-disintegrating-tablet-of-solid-dispersion-of-carvedilol--a-research/akshada-gavhane
Formulation, Evaluation and Optimization of Fast Disintegrating Nifedipine 20...Makrani Shaharukh
Tablet among the all dosage form is the common one and in the Pharmacy it is the mother of Pharmacy. Generally tablet are accepted in all category of patient. In children Dispersible form and in female for virginal infection virginal form are the preferred. The most common preferred route is oral rout of administration. In ancient Ayurveda, Unani, Greek, Egyptian remedies drug in the form of Churna, Bhasma, Gutika, Araka, are administered though oral rout. Pills which are coated by natural resinous material are administered in the form of tablet through oral rout. Today oro-dispersible tablet from novel drug delivery system gain importance from patient. Which is administer to the patient to control the various immediate action viz. attack of angina or hypertension in cardiac problems. Orodispersible tablet gets dispersed in oral cavity in absence of water and release fast drug which result fast pharmacological action. In the market drug from Analgesic, Antipyretic, Antihypertensive and many more are available in the form of the orodispersible tablet. Various manufacture are formulated this formulation by various method. The most importance thing in this formulation are masking of taste of drugs. Generally oro-dispersible tablet are prepared by direct compression method. Dry granulation, wet granulation, Spry drying is the various methods for preparation of oro-dispersible tablet. Oro-dispersible tablet generally contains filler, glidant, antiadherent super disintegrate, Flavoring agent sweetener and resins. Evaluation parameter includes hardness, friability, wetting time, moisture uptake, disintegration test, and dissolution test. Wetting time, Disintegration time, and Dissolution test is directly proportional to the hydrophobic ingredient added for lubrication, anti-adherent, Glidant action. These hydrophobic ingredient are Magnesium Stearate. To oppose the action of magnesium stearate, hydrophilic additives are incorporated viz Sodium lauryl sulphate. From Marketing point of view special Marketing Executive team required to promote the new technique , new formulation with demonstration to the Cardiac Surgeon, Pediatrics, Orthopedics, Gynecologists, Ophthalmologists, Urologist. After demonstration that how to use the Orodispersible tablet these marketing team personally serve to the new admitted patients.
Review on “Mouth Dissolving Tablet as Fast Dissolving Drug Delivery System”ijtsrd
Numerous formulations with enhanced performance and acceptability have been developed in response to the need for greater palatability in oral given medications. Over the past several decades, demand for mouth dissolving tablets MDTs has grown steadily, and the pharmaceutical sector has seen a tremendous expansion in this field. One of the special qualities of mouth dissolving tablets is that they dissolve quickly and release the medication as soon as they come into contact with saliva. This eliminates the need for water when administering the medication. The applications and techniques of taste masking in the past are reviewed in this article, which also focuses on the most current advancements in bitterness reduction for drugs taken orally. In addition to the conventional methods of manufacturing, this review offers a thorough understanding of a few distinct patents these technologies created and commercialised formulations of mouth dissolving tablets MDTs . Adesh Karale | Aditya Karale | Sanket Kachare | Vijay Tarade "Review on “Mouth Dissolving Tablet as Fast Dissolving Drug Delivery System”" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-6 , December 2023, URL: https://www.ijtsrd.com/papers/ijtsrd61260.pdf Paper Url: https://www.ijtsrd.com/pharmacy/other/61260/review-on-“mouth-dissolving-tablet-as-fast-dissolving-drug-delivery-system”/adesh-karale
It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable and practical procedure of manufacture.
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
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
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.
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!
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
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5cl-adba precursor (semi finished )
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Eutylone crystal
Protonitazene (hydrochloride) CAS: 119276-01-6
Flubrotizolam CAS: 57801-95-3
Metonitazene CAS: 14680-51-4
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
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.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
1. Parenteral Production
Department of Pharmaceutics | Sagar savale
Mr. Sagar Kishor Savale
[Department of Pharmaceutics]
Mobile No. +91 9960885333
Email: avengersagar16@gmail.com
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2. Department of Pharmaceutics | Sagar savale
Parenteral Route
It is an route of administration other than the oral route, this route of administration bypasses
the alimentary canal.
It includes, I.V., I. M., Subcutaneous route for parenteral administration.
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3. Advantages
Quick onset of action and site specific or targeted activity.
It can prevent problem of first pass metabolism or presystolic metabolism.
Useful for unconscious or vomiting or diarrhea patients.
Duration of action can be prolonged by modifying formulation.
Suitable for the drugs which are inactivated in GIT or HCl (GI fluid).
Department of Pharmaceutics | Sagar savale
2/27/2017Sagar Kishor Savale 3
4. Department of Pharmaceutics | Sagar savale
Dis-Advantages
Injections may cause pain at the site of injection.
Only trained person is required.
If given by wrong route, difficult to control adverse effect.
Difficult to save patient if overdose.
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5. Types of Parenteral
Department of Pharmaceutics | Sagar savale
Based on types of packaging
• Single dose units: ampoules, infusions and prefilled disposable syringes.
• Multiple dose units: multiple dose vials.
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6. Based on the production and control
• Small volume parenterals: volume < 100 ml, single used, no preservative.
• Large volume parenterals: volume ≥ 100 ml, multiple used, add preservatives.
Department of Pharmaceutics | Sagar savale
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Based on clinical use
• Solutions for irrigation
• Ophthalmic solution
• Dialysis solution
• Diagnostic agent
• Allergenic extracts
• Implants
Department of Pharmaceutics | Sagar savale
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Department of Pharmaceutics | Sagar savale
Based on physical state of product
• Sterile solutions
• Sterile suspensions
• Sterile emulsions
• Sterile solids
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Department of Pharmaceutics | Sagar savale
Subcutaneous (Hypodermis) injection: Below the skin.
Intramuscular injection: Inside the large muscles.
Intravenous injection: inside the veins to blood stream.
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Intra-arterial injection: Inside the arteries.
Intracardiac injection: Inside the Harte veins or cardiac veins.
Intrathecal injection: Inside the spinal cord.
Department of Pharmaceutics | Sagar savale
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Intracisternal injection: Inside the one or two cervical nerve.
Intra-articular injection: Inside the articular ends of joints and bones.
Intracerebral injection: Inside the cerebrum.
Department of Pharmaceutics | Sagar savale
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Department of Pharmaceutics | Sagar savale
Official Types of Injections
Injection: e.g. Insulin Injection USP.
For Injection: e.g. Cefuroxime Injection USP.
Injectable Emulsions: e.g. Propofol USP.
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Injectable Suspension: e.g. Methyl Prednisolone Acetate Suspension USP.
For Injectable Suspension: e.g. Imipenem and Cilastatin Injectable Suspension USP.
Department of Pharmaceutics | Sagar savale
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Department of Pharmaceutics | Sagar savale
Requirements of Parenteral Preparations
Stability
Sterility
Free from Pyrogens and Free from foreign particles
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Isotonicity
Specific gravity
Chemical purity
Department of Pharmaceutics | Sagar savale
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Department of Pharmaceutics | Sagar savale
Formulation of Parenteral Products
1.The active drug
2.Vehicles
• Aqueous vehicle (e.g. water for injection, water for injection free from CO2 ).
• Non-aqueous vehicle (e.g. Ethyl alcohol, propylene glycol, almond oil).
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Department of Pharmaceutics | Sagar savale
Water for
injection
• Not sterilized and pyrogen
free
• It is intended to be used
within 24 hours after
collection
• Total solid contents not more
than 1 mg/100 ml
Sterile water for
injection
• It must be pyrogen free
• endotoxin level is not more
than 0.25 USP
• single dose containers not
larger than 1 liter
Bacteriostatic
water for injection
• One or more suitable
antimicrobial agents
• It is packaged in prefilled
syringes or in vials
• Not more than 30 ml of the
water
• Bacteriostatic agents such as
benzyl alcohol may cause
gasping syndrome
(multiorgan failure)).
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Department of Pharmaceutics | Sagar savaleChloride
Test
Calcium
Test
Heavy
Metal Test
Sulphate
Test
Ammonia
test
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Department of Pharmaceutics | Sagar savale
Cleaning of
containers and
Equipment
Collection of
materials
Preparation of
parenteral products
Filtration
Filling the
preparation in final
container
Sealing the container Sterilization
Evaluation of the
parenteral
preparation
Labeling &
packaging
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Department of Pharmaceutics | Sagar savale
Lay out of Parenteral Manufacturing Area
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Department of Pharmaceutics | Sagar savale
S
T
O
C
K
R
O
O
M
COMPOUNDING
AREA
CLEAN UP
AREA
ASEPTIC
AREA
QUARANTINE
AREA
STERILIZATION
STORAGE
AND
TRANSPORT
PACKING
AND
LABELLING
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Department of Pharmaceutics | Sagar savale
Zones As Per Gazzete of India
1st zones as per gazette of India
BLACK
GRAY
WHITE
White zone: final step (filling of parenteral).
Grey zone: weighing, dissolution & filtration.
Black zone: storage, worst area from
contamination view point.
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1st Zones As Per The C GMP:
• Zone 1: Exterior
• Zone 7: Filling line
• Zone 6: Filling area
• Zone 5: Weighing, mixing & transfer area
• Zone 4: Clean area
• Zone 3: General production
• Zone 2: Warehouse
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Air Handling System (Central Air-Conditioning)
Department of Pharmaceutics | Sagar savale
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Department of Pharmaceutics | Sagar savale
Airborne particulate classification for manufacture of sterile products
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Department of Pharmaceutics | Sagar savale
Types of operations to be carried out in the various grades for aseptic preparations
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Department of Pharmaceutics | Sagar savale
Types of operations to be carried out in the various grades for terminally sterilized products
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Department of Pharmaceutics | Sagar savale
Recommended limits for microbiological monitoring of clean areas “in
operation”
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Department of Pharmaceutics | Sagar savale
The air classification limits stated by USFDA
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Department of Pharmaceutics | Sagar savale
• Biological indicators (BIs) are the most accepted means of monitoring the sterilization process
because they directly determine whether the most resistant microorganisms (e.g., Geobacillus
or Bacillus species) are present rather than merely determine whether the physical and
chemical conditions necessary for sterilization are met.
• Because spores used in BIs are more resistant and present in greater numbers than are the
common microbial contaminants found on patient care equipment, an inactivated BI indicates
that other potential pathogens in the load have also been killed.
Biological indicators (BIs)
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Department of Pharmaceutics | Sagar savale
• Biological indicators (BIs) are used for determination of Bacillus
species.
• BIs such as, ethylene oxide, ethylene chlorohydrin, ethylene hydroxide
and halogenated ethylenehydrine.
• BIs was determined by Z value and D Value.
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Department of Pharmaceutics | Sagar savale
Z value and D Value
Z value is define as Temperature is required to higher death rate.
D value is define as reduction of microbial population by 90 % of the factor 10.
D value is 10 factor greater than Z value.
e.g. D value is 121 ºc as the Z value is 10 ºc.
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Department of Pharmaceutics | Sagar savale
Sterile area: the area which are used to kill the all microorganisms.
Techniques
• Celerity study
• Sterility study
• Leakage study
• Pyrogen study
• LAL test
• Assay for content uniformity study
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Department of Pharmaceutics | Sagar savale
Aseptic area: the area which are used to kill the pathogenic microorganisms.
Techniques:
• HEPA filter integrity test
• Air flow pattern
• Air velocity study
• Heat sensitization study
• Heat distribution study
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Department of Pharmaceutics | Sagar savale
Quality Control of Parenteral Preparations
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Department of Pharmaceutics | Sagar savale
Quality Assurance The planned and systematic activities implemented in a quality system so
that quality requirements for a product or service will be fulfilled.
Quality Control is a procedure or set of procedures intended to ensure that a manufactured
product or performed service adheres to a defined set of quality criteria or meets the
requirements of the client or customer.
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Department of Pharmaceutics | Sagar savale
In Process Quality Control Test
Conductivity measurement
Volume filled
Temperature for heat sterilized product
Environmental control tests
Visual inspection
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Department of Pharmaceutics | Sagar savale
Environmental Control
Traffic control
Surface disinfection personnel
Air control (HEPA filters)
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Department of Pharmaceutics | Sagar savale
Volume Filled
An injection container is filled with a volume in slight excess of the labeled size
Determination of filled volume:
10 mL or more 1 container
3-10 mL 3 containers
Less than 3 mL 5 containers
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Department of Pharmaceutics | Sagar savale
Leakage Test
visual inspection
bubble test
dye tests
vacuum ionization test
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Department of Pharmaceutics | Sagar savale
Clarity Test
Clarity test is carried out to check the particulate matter in the sample.
It is practically impossible that every unit of lost is perfectly free from visible particulate matter
, that is ,from particles that are 30 to 40 micrometer and large in size.
USP limits for large volume infusions
Particle size Particle limit
10 mm (or) larger/ml 50
25 mm (or) larger/ml 5
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Department of Pharmaceutics | Sagar savale
Instrumental Methods
This is also called as the particle count method particle counting may be based on
any one of the following principles; change in
Electrical resistance
Light absorption
Light scattering
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Department of Pharmaceutics | Sagar savale
Criteria For Limulus Test Result
LAL TUBE TEST SAMPLE/CONTROL RESULT
1 Negative control
(pyrogen free saline)
Should be -Ve
2 Positive control (pyrogen ) Should be +Ve
3 Positive internal control
(test sample tainted with exdotoxins)
Should be +Ve
4 Test Sample May be +ve or -Ve
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Methods For Testing
Department of Pharmaceutics | Sagar savale
1. Membrane Filtration Method 2. Direct Inoculation Method
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Department of Pharmaceutics | Sagar savale
MEDIA SUITABLE FOR STERILITY TESTS ARE:
i. FLUID THIOGLYCOLLATE MEDIUM
ii. SOYA-BEAN CASEIN DIGEST MEDIUM
WASH THE FILTERS WITH FLUIDS TO REMOVE
INHIBITORY PROPERTIES, CUTTING THE
MEMBRANES ASEPTICALLY INTO EQUAL
PARTS AND TRANSFERRING ONE OF THE
PARTS TO EACH TYPE OF CULTURE MEDIUM
USED.
THE MEDIAARE THEN INCUBATED UNDER
PRESCRIBED CONDITIONS.
Membrane Filtration
Method
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Department of Pharmaceutics | Sagar savale
Parenteral Preparation
Culture Medium
• This Method Is Only Used When
Membrane Filtration Is Not Possible The
Sample Is Inoculated Directly Into The
Media Or The Device Is Placed Directly
Into The Media.
• Result:
• If No Growth In The Media Then Test Is
Positive.
DirectInoculationMethod
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Department of Pharmaceutics | Sagar savale
Lyophilization or freeze drying
o Lyophilization or freeze drying is a process in which water is removed from a product after it is
frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor
without passing through a liquid phase.
o The process consists of three separate, unique, and interdependent processes;
Freezing,
Primary drying (sublimation), and
Secondary drying (desorption).
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Department of Pharmaceutics | Sagar savale
The advantages of Lyophilization
Ease of processing a liquid, which simplifies aseptic handling.
Enhanced stability of a dry powder.
Removal of water without excessive heating of the product.
Enhanced product stability in a dry state.
Rapid and easy dissolution of reconstituted product.
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Department of Pharmaceutics | Sagar savale
Disadvantages of Lyophilization
Increased handling and processing time.
Need for sterile diluent upon reconstitution.
Cost and complexity of equipment.
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Department of Pharmaceutics | Sagar savale
The Lyophilization process generally includes the following steps
Dissolving the drug and excipients in a suitable solvent, generally water for injection (WFI).
Sterilizing the bulk solution by passing it through a 0.22 micron bacteria-retentive filter.
Filling into individual sterile containers and partially stoppering the containers under aseptic
conditions.
Transporting the partially stoppered containers to the lyophilizer and loading into the chamber
under aseptic conditions.
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Department of Pharmaceutics | Sagar savale
Freezing the solution by placing the partially stoppered containers on cooled shelves in a
freeze-drying chamber or pre-freezing in another chamber.
Applying a vacuum to the chamber and heating the shelves in order to evaporate the water
from the frozen state.
Complete stoppering of the vials usually by hydraulic or screw rod stoppering mechanisms
installed in the lyophilizers.
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Department of Pharmaceutics | Sagar savale
There are many new parenteral products, including anti-infectives, biotechnology derived
products, and in-vitro diagnostics which are manufactured as lyophilized products.
Additionally, inspections have disclosed potency, sterility and stability problems associated
with the manufacture and control of lyophilized products.