Looking for a Tutor Near You?

Post Learning Requirement »
x

Choose Country Code

x

Direction

x

Ask a Question

x

x
x
For better view click here
x
Hire a Tutor
DISCOVER

Biopharmaceuticals

Loading...

Published in: Microbiology | Pharmacy
113 Views

This notes has a part of Biopharmaceuticals, which can be helpful for pharmacy, biochemistry and microbiology students

Shatakshi M / Pune

3 years of teaching experience

Qualification: B.Sc (Haribhai V. Desai College - 2021), M.Sc (Haribhai V. Desai College - 2023)

Teaches: Biology, Chemistry, Mathematics, Algebra, EVS, Science, Bio Chemistry, Microbiology, M.Sc Tuition

Contact this Tutor
  1. Biopharmaceuticals: Regulations and sources A. Regulatory authorities and its role: FDA, WHO and CLSI B. Formulation Of following pharmaceutical preparation as per IP: Antibiotics (with any one example) Antipyretics (with any one example) Steroids (with any one example) Injectables (Distilled water, Saline) Vitamins (with any one example) Regulatory Authorities and its role: FDA, WHO and CISI FDA The food and drug administration (FDA) is the American regulatory authority. Its mission statement defines its goal simply as being 'to protect public health'. n fulfilling this role, it regulates many products/consumer items. It works entails inspecting/regulating almost 100,000 establishments in USA (or those abroad who export regulated products for American consumption). The FDA was founded in 1927. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security Of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
  2. Center for Biologics Evaluation and Research Center for Food Safely and Applied Nutrition Office of the Commissioner National Center for •loxicological Research Center for Devices and Radiological Health Center for Drugs Evaluation and Research Center Medicine Figure 2.10. Partial organizational structure of the FDA, displaying the various centres primarily responsible for regulating drugs, devices and food FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfils this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats. Substances regulated by FDA are foods, nutritional supplements, drugs, chemical based, biologics, biopharmaceuticals, blood supply and blood products, cosmetics/toiletries, medical devices, microwave ovens, all radioactivity-emitting substances, advertising and promotional claims relating to the above product types. FDA regulates:
  3. Foods, including- dietary supplements, bottled water, food additives, infant formulas, other food products (although the U .S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products) Drugs, including- prescription drugs (both brand-name and generic), non-prescription (over- the-counter) drugs Biologics, including- vaccines for humans, blood and blood products, cellular and gene therapy products, tissue and tissue products, allergenics Medical Devices, including- simple items like tongue depressors and bedpans, complex technologies such as heart pacemakers, dental devices, surgical implants and prosthetics Electronic Products that give off radiation, including- microwave ovens, x-ray equipment, laser products, ultrasonic therapy equipment, mercury vapor lamps, sunlamps Cosmetics, including- colour additives found in makeup and other personal care products, skin moisturizers and cleansers, nail polish and perfume Veterinary Products, including- livestock feeds, pet foods, veterinary drugs and devices Tobacco Products, including- cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, Cigars, Hookah, E-cigarettes (tobacco and non-tobacco derived nicotine) The core activities of biopharmaceutical drug approval/regulation are undertaken mainly by the Centre for Drug evaluation and Research (CDER) and Centre for Biologics Evaluation and Research (CBER).
  4. Filed NDA Pri mary Secondary review' Review and recommendation (for approval or otherwise) Multidisciplinary review expert panel Sugvviscrs of the individual members of the initial review FDA division directcr Figure 2.12. The CDER review process fora typical NDA. In addition to the review stages described, the FDA also may consult with a technical advisory committee. The members of the advisory committee are not routinely involved in IND or NDA assessment. The FDA is not obliged to follow any advice given by the advisory committee. but it generally does so The major FDA responsibilities with regard to drugs include: To assess pre-clinical data and decide whether a potential drug is safe enough to allow commencement of clinical trials. To protect the interests and rights of patients participating in clinical trials. To assess pre-clinical and clinical trials data generated by a drug and decide whether that drug should be made available for general medical use (i.e. whether it should be granted a marketing license) To oversee the manufacture of safe effective drug (inspect and approve drug manufacturing facilities on the basis Of compliance to the principles of good manufacturing practice as applied to pharmaceuticals) To ensure the safety of the US blood supply. In relation to drug development process, CDER oversees and regulates the development and marketing approval of mainly chemical-based drugs. CBER is more concerned with biologics. Biopharmaceutical products have not fallen neatly into either category and the decision to refer any biotech-derived drug to CBER or CDER is taken on a case-by-case
  5. basis. Tissue plasminogen activator is licensed as a biologic, whereas erythropoietin comes under the auspices of CDER. The majority of biopharmaceuticals, are assessed by CBER. The criteria used by CBER and CDER regulators in assessing product performance during the drug development process are similar i.e. safety, quality and efficacy. However, the administrative details can vary in both name and content. Upon concluding pre-clinical trials, all the data generated regarding any potential new drug are compiled in a dossier and submitted to CDER or CBER in the form of an investigational new drug application (IND application). The FDA assess the application, and if it does not object within a specific time frame (usually 30 days), clinical trials can begin. The FDA usually meet with the drug developers at various stages, to be updated and often to give informal guidance/advice. Once clinical trials have been completed, all the data generated during the entire developmental process are compiled in a multi-volume dossier. Initial IND application submi Lted to FDA Sponsor provides FDA review (30 days max) ication withheld ( further infomation required) Figure 2.11. Outline of the IND application process The dossier submitted to CDER is known as a new drug application (NDA) which, if approved, allows the drug to be marketed. If the drug is a CBER-regulated one, a biologics licence application (BIA) is submitted. WHO The World Health Organization (WHO) is a specialized agency Of the United Nations responsible for international public health. The WHO Constitution, which establishes the agency's governing structure and principles, states its main objective as "the attainment by all peoples of the highest possible level of health "
  6. It is headquartered in Geneva, Switzerland, with six semi-autonomous regional offices and 150 field offices worldwide. World Health Organization The WHO was established by constitution on 7 April 1948, which is commemorated as World Health Day. The WHO's broad mandate includes advocating for universal healthcare, • monitoring public health risks, coordinating responses to health emergencies, • and promoting human health and well-being. It provides technical assistance to countries, sets international health standards and guidelines, and collects data on global health issues through the World Health Survey. Its flagship publication, the World Health Report, provides expert assessments of global health topics and health statistics on all nations. The WHO also serves as a forum for summits and discussions on health issues The WHO has played a leading role in several public health achievements, most notably the eradication of smallpox, the near-eradication Of polio, and the development of an Ebola vaccine. current priorities include communicable diseases, particularly HIV/AIDS, Ebola, COVID-19, malaria and tuberculosis; non-communicable diseases such as heart disease and cancer; healthy diet, nutrition, and food security; occupational health; and substance abuse. It is composed of representatives from all 194 member States, serves as the agency's supreme decision-making body. It also elects and advises an executive board made up of 34 health specialists. It convenes annually and is responsible for selecting the director-general, setting goals and priorities, and approving the WHO's budget and activities.
  7. The current director-general is Tedros Adhanom, former health minister and foreign minister Of Ethiopia, who began his five-year term on I July 2017 The WHO's Constitution states that its objective "is the attainment by all people of the highest possible level of health". The WHO fulfils this objective through its functions as defined in its Constitution: To act as the directing and coordinating authority on international health work; To establish and maintain effective collaboration with the United Nations, specialized agencies, governmental health administrations, professional groups and such other organizations as may be deemed appropriate; To assist Governments, upon request, in strengthening health services; To furnish appropriate technical assistance and, in emergencies, necessary aid upon the request or acceptance of Governments; To provide or assist in providing, upon the request of the United Nations, health services and facilities to special groups, such as the peoples Of trust territories; To establish and maintain such administrative and technical services as may be required, including epidemiological and statistical services; To stimulate and advance work to eradicate epidemic, endemic and other diseases; To promote, in co-operation with other specialized agencies where necessary, the prevention of accidental Injuries; To promote, in co-operation with other specialized agencies where necessary, the improvement Of nutrition, housing, sanitation, recreation, economic or working conditions and other aspects of environmental hygiene; To promote co-operation among scientific and professional groups which contribute to the advancement of health, To propose conventions, agreements and regulations, and make recommendations with respect to international health matters and to perform As of 2012, the WHO has defined its role in public health as follows: • providing leadership on matters critical to health and engaging in partnerships where joint action is needed;
  8. shaping the research agenda and stimulating the generation, translation, dissemination of valuable knowledge setting norms and standards and promoting and monitoring their implementation; articulating ethical and evidence-based policy options; and providing technical support, catalysing change, and building sustainable institutional capacity; and monitoring the health situation and assessing health trends. CRVS (civil registration and vital statistics) to provide monitoring of vital events (birth, death, wedding, divorce The WHO estimates that 12.6 million people died as a result Of living or working in an unhealthy environment in 2012 — this accounts for nearly I in 4 of total global deaths. Environmental risk factors, such as air, water, and soil pollution, chemical exposures, climate change, and ultraviolet radiation, contribute to more than 100 diseases and injuries. This can result in a number of pollution-related diseases Our primary role is to direct and coordinate international health within the United Nations system. Our main areas of work are health systems; health through the life-course; noncommunicable and communicable diseases; preparedness, surveillance and response; and corporate services. We support countries as they coordinate the efforts of governments and partners — including bi- and multilaterals, funds and foundations, civil society organizations and the private sector. Working together, we attain health objectives by supporting national health policies and strategies. CLSI The International Organization for Standardization (ISO) is an international body composed Of representatives from various global standards organizations. CLSI is the American representative for the Technical Committee of the International Organization for Standardization, which means we are helping shape international lab standards with our colleagues in dozens of other countries. Clinical laboratory testing and in vitro diagnostic test systems. ISO/TC 212 is responsible for international standardization and guidance in the field Of laboratory medicine and in vitro diagnostic test systems.
  9. CLSI's collaborative approach ensures balanced representation from the global laboratory community to yield unbiased consensus standards that can be confidently adopted by laboratories, clinicians, regulatory agencies, and industry throughout the world. The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit organization that develops laboratory standards worldwide. Our standards are recognized by laboratories, accreditors, and government agencies as the best way to improve medical laboratory testing. CLSI's unique consensus process brings together experts from industry, government, and health care professions to develop timely standards recognized by laboratories, industry, accreditors, and regulators as the way to improve testing. (2) (2) (P) rut The purposes of CLSI shall be: a) To develop and promote the evaluation, approval, and implementation Of standards and guidelines (collectively "standards") for health care services and medical laboratory services b) To provide a mechanism for approval of standards based on a consensus of parties interested in the scope, provision, and use of such standards c) To maintain a forum for communication among government, industry, and health care professions as well as other entities concerned with the quality Of health care services, medical laboratory services, and the relationship Of standards thereto d) To provide education regarding the use of standards in the delivery of quality health care services and medical
  10. laboratory sen;ices e) To develop, modify, and implement policies, processes, and procedures consistent with these Bylaws Formulation Of following pharmaceutical preparation as per IP: A. Antibiotics (with any one example): Amoxicillin Amoxicillin (a-amino-hydroxybenzyl penicillin) is a semisynthetic antibiotic; belonging to ß- lactam family. Amoxicillin is effective against many different bacteria including Haemophilus influenza, Neisseria gonorrheae, Escherichia coli, Salmonella, Proteus mirabilis, Enterococci, Streptococci, Listeria, Helicobacter pylori and certain strain Of Staphylococci. It inhibits cross-linkage between peptidoglycan polymer chains that make up a major component of the cell walls of both gram-positive and gram-negative bacteria. Amoxicillin is used for infections of middle ear, tonsils, upper and lower respiratory tract, urinary tract, skin and stomach in adult and pediatric patients. CH3 CHs The amoxicillin molecular formula is C 161119N305S•3H20, and the molecular weight is 419.45. Amoxicillin is commercially available in trihydrate form. Amoxicillin is used as powder for suspension at two strengths of 125 mg and 250 mg in children. An important disadvantage of suspensions is inter-dose variability, often seen when patient forgets shaking the bottle before taking the medication. Phase separation and difficulty of reconstituting suspension are other problems of the dosage form. The therapeutic effect of amoxicillin suspensions may change and decline from the I st day to the last day of treatment. In addition, patients may avoid carrying the medication with them when away from home, resulting in poor compliance and the failure of therapy. Certain amount of citric acid and sodium bicarbonate were mixed together and heated at 540C for about 15 min. The granules were dried for 1/2 h in the oven at 600C. Finally, amoxicillin dry granules and remaining ingredients of formulation were added and mixed, to which the lubricant was added.
  11. Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side. Inactive ingredients: Colloidal silicon dioxide, crospovidone, FD&C Red No. 30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. B. Antipyretics (with any one example): Paracetamol (Acetaminophen) Paracetamol is used as an analgesic and antipyretic drug. It is the preferred alternative analgesic-antipyretic to aspirin (acetylsalicylic acid), particularly in patients with coagulation disorders, individuals with a history of peptic ulcer or who cannot tolerate aspirin, as well as in children. Paracetamol is available in pure form as numerous trade-name preparations for oral use. It is also found combined in over 200 preparations with other drugs. Paracetamol is available as 325-mg or 500-mg tablets, which may include calcium stearate or magnesium stearate, cellulose, docusate sodium and sodium benzoate or sodium lauryl sulfate, starch, hydroxypropyl methylcellulose, propylene glycol, sodium starch glycolate, polyethylene glycol and Red #40. CH3CONH C8H9N02 OH Mol. we 151.16 The conventional oral dose for adults is mg. Dosing may be repeated every 4 h as necessary, but the total daily dose should not exceed 4000 mg. For children, the recommended dose is 10—15 mg/kg bw; no more than five doses should be administered over 24 h. Wet granulation methodology is widely used for preparation of paracetamol granules/tablets. For the granulation, paracetamol and starch powder is mixed and granulated with starch paste (binder). Granulating Starch powder will be used to disintegrate granules. Requirements: Chemicals: Paracetamol IP, starch, magnesium stearate, talc, methyl paraben Glassware: Memsuring cylinder, beaker, mortar and pestle, granulating sieve, etc.
  12. Formula: Granulation Sr no. Ingredients 2. 3. Paracetamol IP Starch paste Starch powder Quantity given 500 mg 12.5 mg Quantity given -log 5% 5% 0.1% Quantity taken 10 g -5 ml (0.5g) 0.25 g Use Disintegration Lubricant Glidant Preservative Use Antipyretic Binder Disintegration Post granulation Sr no. 2. 3. 4. 5. Ingredients Granules Starch powder Magnesium stearate Talc Methyl paraben Procedure : 2. 3. 4. Weigh and pass paracetamol powder through 100# sieve. Mix paracetamol and starch powder uniformly in mortar and pestle. Prepare 10 % starch paste in boiling water and stir until it becomes translucent. Add starch paste dropwise in mortar to get cohesive mass. Record quantity of starch paste used for granulation. 5. Screen prepared cohesive mass through 12# granulating sieve and collect it on granulating tray. 6. Dry granules in tray at 50 oc for 30 min. Pass 50 % dried granules through sieve to get uniform particle size and continue drying for 30 min. 7. Using 22/44 # sieve separate granules and fine particles. Material on 22# sieve is final granules and on 44# sieve is fine. Record the weight of final granules and fines. 8. If the quantity of fines is more than 10% of final granules then recycle the fines. 9. Finally take the weight of granules and blend granules with remaining ingredients in a polybag. 10. Store prepared granules in well closed and labelled container till evaluation.
  13. Storage: Store in well closed container in cool and dry place. C. Steroids (with any one example) The term steroid applies to a wide range of molecules with varying physiological effects. More specifically, corticosteroids are a class of chemicals encompassing both laboratory- synthesized and naturally produced hormones. Glucocorticoids, in general, regulate metabolism and inflammation; mineralocorticoids regulate sodium and water levels. Corticosteroids fall along a spectrum from exclusively glucocorticoid effects to exclusively mineralocorticoid effects, and steroid compounds are selected based on their appropriateness for a given treatment. For example, although a compound may possess potent anti-inflammatory properties, it may additionally have mineralocorticoid activity that adversely affects blood pressure. Steroid injections are associated with side effects related to dosage, duration of administration, added ingredients or contaminates, and particle size. Particulate steroids present a theoretical risk Of occluding vessels depending on the size of particulate aggregates. Common additives in steroid preparations, such as benzyl alcohol and ethylene glycol, have been implicated in case reports and studies of complications following epidural steroid administration. Dexamethasone and betamethasone sodium phosphate are pure liquids, whereas methylprednisolone, triamcinolone, and betamethasone are solutions, and their particle size depends upon the type Of preparation and dosage. Studies have shown that transforaminal dexamethasone is just as effective at 4 mg as it is at 8 mg and 12 mg and that nonparticulate steroid preparations are just as effective as particulate preparations in treating cervical radicular pain. Methylprednisolone and triamcinolone are the drugs most commonly used for epidural steroid injections. Common side effects of epidural steroid injections are paresthesia, pam on
  14. Injection, intravascular injection, bleeding, and dysesthesia. The most serious complications Of epidural steroid injections are related to intravascular injections. Intraarterial injections may occur even with a negative aspirate and have been shown to potentially cause paraplegia. Although the use of computed tomography guidance instead of conventional fluoroscopy provides a better image of relevant anatomy, it does not assure avoidance of these adverse events. Topical corticosteroids (2.5% ointment, triamcinolone 0.1 % ointment, and clobetasol propionate 0.05% foam) achieve more effective skin concentrations than oral prednisone. Side effects, including skin thinning, colour change, and systemic effects, can be expected with topical application of corticosteroids and increase in a dose-dependent manner. Inhaled corticosteroids have evolved into a mainstay Of therapy for moderate to severe asthma. Effectiveness and systemic bioavailability vary with each corticosteroid molecule and dosage, but in general, systemic effects are minimized with proper administration. Common side effects of inhaled corticosteroids include gingival irritation and oral candidiasis, as well as the many systemic effects associated with corticosteroid use. Fludrocortisone is a synthetic corticosteroid that has potent mineralocorticoid effects. It has been used clinically to achieve the mineralocorticoid effects Of sodium and water retention in cases of cerebral salt wasting, orthostatic hypotension, and adrenocortical insufficiency in Addison disease. Potassium wasting is a common side effect Of fludrocortisone administration, and electrolyte levels should be monitored while a patient is undergoing fludrocortisone administration. Agent Cottisol Triamcd1010ne (Aristocort) 6•Methylprednisolone (Depo•Medrol) Betamethasone (Cehstone) Fludrocortisone Antiinnammatory Potency Relative to Cortisol 5 5 25 10 Mineralocorticoid Potency Relative to Cortisol 125 Duration of Action. hours 8-12 12-36 12-36 36-72 Equivalent Dose, mg 20 4 4 0.75 is table in 34: ed, ArWt•Ä PA Elsew
  15. D. Injectables (Distilled water, Saline) Distilled water Water is one of the major commodities used by the pharmaceutical industry. It may be present as an excipient or used for reconstitution of products, during synthesis, during production Of the finished product or as a cleaning agent for rinsing vessels, equipment, primary packaging materials etc. Different grades of water quality are required depending on the different pharmaceutical uses. Control of the quality of water, in particular the microbiological quality, is a major concern and the pharmaceutical industry devotes considerable resource to the development and maintenance of water purification systems. Distilled water is produced by vaporizing liquid water and condensing if in a purer state. It is used primarily as a solvent for reagent preparations, but it is also specified in the execution of Other aspects of tests such as rinsing an analyte, transferring a test material as a slurry, as a calibration standard. Distillation units provide chemical and microbial purifications via thermal vaporization, mist elimination and water vapour condensation. A variety of designs is available including single effect, multiple effect, and vapor compression. The latter two configurations are normally used in larger systems because of their generating capacity and efficiency. Distilled water systems require different feed water controls than required by membrane systems. For distillation, due consideration must be given to prior removal of hardness and silica impurities that may foul or corrode the heat transfer surfaces as well as prior removal of those impurities that could volatize and condense along with the water vapor. In spite Of general perceptions, even the best distillation process cannot afford absolute removal of contaminating ions and endotoxin. Most stills are recognized as being able to accomplish at least a 3 to 4 log reduction in these impurity concentrations. Methods of control may involve preliminary decarbonation steps to remove both dissolved carbon dioxide and other volatile or non-condensable impurities; reliable mist elimination to minimize feedwater droplet entrainment; visual or automated high water level indication to detect boiler flooding and boil over; use of sanitary pumps and compressors to minimize microbial and lubricant contamination Of feedwater and condensate; proper drainage during
  16. inactive periods to minimize microbial growth and accumulation of associated endotoxin in boiler water; blow down control to limit the impurity concentration effect in the boiler to manageable levels; on-line conductivity sensing with automated diversion to waste to prevent unacceptable water upon still startup or still malfunction from getting into the finished water distribute system; and periodic integrity testing for pinhole leaks to routinely assure condensate is not compromised by non-volatized source water contaminants. Water for Injections (WFI) is water for the preparation of medicines for parenteral administration when water is used as a vehicle (water for injections in bulk) and for dissolving or diluting substances or preparations for parenteral administration (sterilised water for injections). Water for Injection: Indications In preparations intended for parenteral administration and in Other sterile preparations. Availability: Ampoule l, 5 and 10 ml. Storage: Store in a single dose container at a temperature not exceeding 300C. Saline Saline solution is a mixture of salt and water. The normal saline solution contains 0.9 percent sodium chloride (salt), which is similar to the sodium concentration in blood and tears. Saline solution is usually called normal saline, but it's sometimes referred to as physiological isotonic saline. It contains no antimicrobial agent; as it is a large volume and single-dose parenteral preparation. Sodium Chloride Injection contains not less than 0.85% w/v and more than 0.95% w/v of sodium chloride. • Formula: Sr. Quantity 0.9 mg 100 ml Quantity Given (Factor x Sodium Chloride Water For Role Of Ingedients Electroly te Vehicle Factor = Procedure: Re quire d Quantity Quantity Given 1) Accurately weigh all the ingredients.
  17. 2) Add sodium chloride in a suitable sterile container and add a sufficient quantity of water for injection to make the required volume. Stir to dissolve. 3) If the solution is clear or not, filter the solution by using sintered glass filter. 4) Fill the clear filtrate solution into the stainless-steel pressure tank and aseptically pass- through membrane filter of 0.22 um. 5) Fill the solution aseptically into a sterilized container and close with a sterilized rubber closure and seal it with aluminium cap. 6) Check the leakage and reject the leaking container. 7) Examine the solution critically for particulate matter. 8) Then sterilized by autoclave at temperature1210C and pressure 15 lbs /sq. inch for 20 mms. 9) Switch off the autoclave. Allow it to cool and the pressure to come to zero, then remove containers. 10) Polish the container and re-examine for the particulate matter and leakage. Il) Label it and submit. Category: Fluid and Electrolyte replenisher. Dose: As directed by a physician. To be used with non-pyrogenic I. V. administration set with aseptic technique. Storage: It should be stored in a cool dark place, protect from light. Direction: For I.V. use only. Precautions: Only for single-use, discard any unused portion immediately. Even invisible damage to the container may result in contamination. Do not use if the container is found to leak or the solution contains visible solid particles. E. Vitamins (with any one example): Retinol (Vitamin A) Vitamins are used for the prevention and treatment of specific deficiency states or when the diet is known to be inadequate. It has often been suggested but never convincingly proved, that subclinical vitamin deficiencies cause much chronic ill-health and liability to infections. This has led to enormous consumption of vitamin preparations, which have no more than placebo value.
  18. Vitamin A is a fat-soluble vitamin necessary for health, deficiency of which can cause disorders of vision, skin, bone and immunity. The recommended daily allowance for vitamin A is 300 to 700 pg for children and approximately 700 to 900 pg for adults, amounts which can be provided by a normal diet. Higher doses of vitamin A can be toxic, leading to a constellation Of signs and symptoms as well as liver Injury, jaundice, enlargement of the liver and spleen, portal hypertension and cirrhosis. Vitamin A is isolated by liquid-liquid extraction, molecular distillation, and HPLC. AQUASOL A@ Parenteral (water-miscible vitamin A Palmitate) provides 50,000 USP Units of vitamin A per mL as retinol (C20H300) in the form Of vitamin A palmitate, a light yellow to amber oil. The structural formula of retinol is: CH3 CH3 H2C H2C C—CH3 CHs CH3 CH— CH CH CH CH20H Ordinarily oil-soluble, the vitamin A in this product has been water solubilized by special processing* and is available in a water solution for intramuscular injection. One USP Unit is equivalent to one international unit (IU) and to 0.3 mcg of retinol or 0.6 mcg of beta-carotene.
  19. Commercial isolation of retinol from natural raw materials Starts with fish oils and is conducted in six steps: (l) accumulation of crude vitamin A by the Solexol countercurrent extraction process (2) short-path distillation of the retinyl esters (200 oc, 400 Pa) (3) ester saponification (KOH, 60-70 oc, 30 minutes, N2) (4) extraction of retinol with ether (5) short-path distillation of retinol (120 oc, 400 Pa) (6) final purification by crystallization from ethyl formate (-35 oc) With the development Of efficient processes for the synthesis of vitamin A on a commercial scale, isolation from natural raw materials has lost importance. References: https://www.fda.gov/ https://www.ncbi.nlm.nih.gov/books/NBK526213/ https://www.research2ate.net/publication/28083951() Preparation of Paracetamol G ranules Aqueous wet granulation https://www.accessdata.fda.gov/drugsatfda docs/label/2008/050760sl 1,050761sl 1,05 0754s12.050542s251b1.pdf https://w ww. ncbi. nlm .mh. gov/pmc/articles/PMC4219208/ https://pubchem.ncbi.nlm.nih.gov/compound/Retinol https://www.rxlist.com/aquasol-a-drug.htm#description https://main.mohfw.gov.in/sites/default/files/7966072180. pdf https://w ww. ema.europa.eu/en/documents/scientific- guideline/draft-guideline-quality- water-pharmaceutical-use en.pdf http://pharmacopeia.cn/v29240/usp29nf24s0 cl 231 .html https://pharmacyinfoline.com/normal-saline-solution/ https://www.ncbi.n1m.mh.gov/pmc/artic1es/PMC4052587/#:-:text=CORTICOSTERO um%20phosphate.type%200f%20preparation%20and%20dosage. https://clsi.org/
  20. Walsh G. (2006). Biopharmaceuticals: Biochemistry and Biotechnology. 2nd edition. Wiley (E-Book, 2013). https://www.who.int/ https://www.google.com/imgres?imgurl=https%3A%2F%2Fwww.un.org%2Fyouthen voy%2Fwp- 1=https%3A%2F%2Fwww.un.org%2Fyouthenvoy%2F2013%2F09%2Fwho-wor1d- health- gkOM& KEwjdpofUg0f9AhWg43MBHV8iCHYQMygCegUIARCMAQ

Need a Tutor or Coaching Class?

Post an enquiry and get instant responses from qualified and experienced tutors.

Post Requirement

Related Study Notes

Upload Study Notes

If you have your own Study Notes which you think can benefit others, please upload on LearnPick. For each approved Study Note you will get 100 Credit Points and 100 Activity Score which will increase your profile visibility.

Upload Now
Home > Study Notes > Biopharmaceuticals