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Formulating medicines are the processed drugs which are produced and designed in a particular way and sold to the patients in the time of need as pharmaceuticals. In this process, the active drug is compiled with other important components by judging the polymorphism, particle size, solubility and pH and it makes beneficial effects to the drug. There are some advantages of formulating medicines which are developing the preparation of adequacy and forming the particular drug which is very acceptable and stable to the patient. Means it improves the tolerability and efficacy effects and leads to the developing process which directly relates with the quality of health (Kharel et al. 2020). The novel formulations are enhancing bioavailability, solubility, protecting from toxicity, developing of stability, pharmacological activity and improving the distribution of tissue macrophages. It is important because it reduces the administration repeatedly to avoid the non-compliance level but increases the value of therapy by increasing the bioavailability and reducing the toxicity. Means it is the type of novel approach which helps in drug delivery by addressing the limitations of the delivery systems of the novel drugs. Inhalers and nebulizers are examples of drug formulation. Nebulizers reduce the effect of inflammation in the open airways or lungs and it turns liquid medicine into mist after formulation.
It also has the properties of anti-inflammatory, analgesic and antipyretic. The main pharmacological effect of the drug is that it helps to reduce the substances from the body which causes inflammation and pain (Williams et al. 2019). The administration route of free acid capsule is oral use. It is a high dose drug which can have side effects in the patient body after taking the medicines like stomach ache, heartburn, nausea, constipation, diarrhea, headache, gas, dizziness and drowsiness. So before taking the drug, a person must consult with the doctors or supervisors to know about the proper dose of the drug. The next drug is sodium enteric coated tablet and they all are the parts of diclofenac. So the physiochemical property is C14H11C12NO2. Sodium enteric coated tablet is used in the time of migraine headaches (Jadhav et al. 2020). It works so fast and the drug takes 15 minutes to do its work. It is a type of oral powder and the recommendation is for 18 years olds and the aged people. It can be taken thrice in a day and the amount can be 50 mg.
Sodium enteric coated tablet is an anti-inflammatory no steroidal drug. It helps to reduce inflammation and relieve pain like redness and swelling. As for the pharmacological effects, it is an oral solution of a drug which is used in the time of ankylosing spondylitis and arthritis. The powder also lowers the risk of heart attack and headache. The administration route for diclofenac doses are intramuscular, oral, transdermal, intravenous and rectal. Here the term is oral and one packet of sodium enteric coated tablet is mixed well in a cup of water and given to the patients immediately.
There are also some side effects of sodium enteric coated tablet which can be suffered by the patients like itching, sweating, dizziness, drowsiness, indigestion and stomach pain. Last one is potassium immediate release tablet and the functional groups of potassium immediate release tablet are alcohol, ketone, carboxylate salt, aromatic amine halogen and carboxylic acid (Tsakalozou et al. 2021). The molecular weight of this is 295 and the molecular formula is C4H10Cl2NO2. The works of potassium immediate release tablet are pooling through on the upper surface of the skin, penetrating the underlying tissues on the inflamed areas to decrease swelling and relieve pain. It can be taken 4 times in a day and the result can be obtained in 7 days. It gives more potential effect than ibuprofen and tylenol. More than 8 gram is not applicable and it can be harmful to the body. It also reduces the inflammation of the day if the dose is proper. The pharmacological effects are decreasing the chance of pain, swelling and fever (Russo et al. 2020). The administration route of potassium immediate release tablet is something different from above because it is given by intragluteal deep injection into the outer upper quadrant using the techniques of aseptic. The bad results for patients are heartburn, nausea, indigestion and diarrhea.
Bulk characteristic of the drugs are the solid state which can make a great impact in the human body for developing the whole process. It has also the nature of drug solubility, dissolution rate, partition coefficient, polymorphic stability and forms. So from the first time, the people must be careful before using these types of drugs and intake it in a limitation. It helps to generate the informative data which are useful for stabling condition and make safe dosages which is manufactured on the purpose of commercial use. Absolute solubility, molecular dissociation, solvent solubility in a various way and solubility rate is the main intrinsic factors of the molecule. In this phase, the development and research help in the preformulation study to make the chemical and physical properties good, useful and safe to the people because every dose must be stable and effective as it has the power to remove disease from the body. Physiochemical characterization, salty selection, purity determination, polymorphic screening, excipients selection and compatibility studies are the overall processes of drug selection. Here are some solubility factors of the process like the solvent and solute should be pure, the saturation of the solution must be obtained before removing any sample from the analyzing system. The main aim of the test is to use and establish the important physiochemical parameters with the help of a new substance of the drug.
Here the description is about three doses of diclofenac like free acid capsule, sodium enteric coated tablet and potassium immediate release tablet. First, free acid capsule is an anti-inflammatory non-steroidal drug. Indomethacin, ibuprofen, naproxen and nabumetone are similar types of free acid capsule and the effects of these types of drugs are most probably the same (Drumond et al. 2021). But it is not appropriate for children who are less than 18 years old because it can have harmful side effects for them. Otherwise it reduces inflammation and pain which can be the cause of ankylosing spondylitis or arthritis. Diclofenac potassium is the active reagent of free acid capsule and the formula is called NSAIDs means it is the type of anti-inflammatory non-steroidal drug.
The helpful doses of free acid capsule are Maize starch, glycollate, microcrystalline cellulose and calcium phosphate, titanium dioxide, iron red oxide, sucrose and talc. The amount is 100 mg per day and the making doses of free acid capsule are also used as the basis of it. But the dose can be divided twice or thrice in a day for getting the better result. All doses have their own medical value and without one of them the making process of free acid capsule is not completed. Aniline and 2, 6 two chlorophenol are the raw doses to make diclofenac and it is the same for free acid capsule (Lafeber et al. 2022). Other one is sodium enteric coated tablet and the particles of sodium enteric coated tablet are flavoring agents, mannitol, glyceryl behenate, potassium bicarbonate, mannitol and sucralose. Here the three dosages forms of diclofenac are free acid capsule, sodium enteric coated tablet and potassium immediate release tablet. Ibuprofen contain as the particle of free acid capsule. Sodium, waxes, fatty acid, shellac, plant fiber and plastic contain in sodium enteric coated tablet. White potassium chloride, effervescent tablets and oral solution contain in potassium immediate release tablet. Diluents, glidants, lubricants, wetting agents, disintegrate and adhesives are the excipient categories which are used to highlight the excipient formula of free acid capsule. Acetate polyvinyl phthalate, methylcellulose hydroxypropyl phthalate, acetate cellulose phthalate and diethyl phthalate are the excipient categories which are used to highlight the excipient formula of sodium enteric coated tablet. Ethyl cellulose, crospovidone, hydroxypropyl cellulose, microcrystalline cellulose and magnesium stearate are the excipient categories which are used to highlight the excipient formula of potassium immediate release tablet.
For free acid capsule, 4gm diluents, 2.8gm glidants, 5.3gm lubricants, 6ml wetting agents, 3.4gm disintegrate and 5.2gm adhesives are the mixture of the total calculations.
Calculation for free acid capsule of each ingredient in a batch of 100kg
(4+2.8+5.3+6+3.4+5.2) / 100000 = 0.0002gm
For sodium enteric coated tablet, 2.4gm acetate polyvinyl phthalate, 3.5gm methylcellulose hydroxypropyl phthalate, 5.6gm acetate cellulose phthalate and 4.7gm diethyl phthalate are the mixture of the total calculations.
Calculation for sodium enteric coated tablet of each ingredient in a batch of 100kg
(2.4+3.5+5.6+4.7) / 100000 = 0.0001gm
For potassium immediate release tablet, 3gm ethyl cellulose, 2.9gm crospovidone, 5gm hydroxypropyl cellulose, 6.1gm microcrystalline cellulose and 2gm magnesium stearate are the mixture of the total calculations.
Calculation for potassium immediate release tablet of each ingredient in a batch of 100kg
(3+2.9+5+6.1+2) / 100000 = 0.0001gm
But for diclofenac, the average dosage is 248mg for each drug and the calculation of 100 kg is (3*248) / 100 = 7.44
The specific equipment in the time of manufacturing the drugs is proper temperature, pressure and additional mixing material to make the drugs dry and forming the exact shapes of them. There are some different types of experimental categories of sodium enteric coated tablet like cork sodium enteric coated tablet, vascular sodium enteric coated tablet and uniaxial sodium enteric coated tablet. These all are the three genetic types of sodium enteric coated tablet and all have the different medical effects to make a valuable effect to the patient. First 2 hours the medicine is super active and this time the heavy meal should not be taken. But after 24 hours it reduces the effect of it and it becomes inactive. Sodium enteric coated tablet is mixed properly with water before taking it and it is the type of oral powder. The requirement of it depends on the condition of the patient because it can be taken from 70 mg to 200 mg per day. It reduces the bad effects of ankylosing spondylitis and arthritis, redness, swelling and headache (Dhaval et al. 2020). Along with this, it can reduce the risk of heart disease and decrease the chance of heart attack.
Sodium enteric coated tablet is a prescription medicine which is not allowed for children under 18 years old because it can cause an immediate side effect for them. It is mixed with one cup of water before in taking it, shake well and drink immediately otherwise it loses its medicine effect. The modification particles of potassium immediate release tablet are naproxen, celecoxib and diclofenac and these three are the main ingredients to make the drug properly. It is the main substance of diclofenac sodium which is an anti-inflammatory non-steroidal drug. The functional groups of potassium immediate release tablet are alcohol, ketone, carboxylate salt, aromatic, amine halogen and carboxylic acid. The substance of potassium immediate release tablet is calculated here by the measurement of daily intake limit and if it crosses then there can be a harmful side effect for the patients. The harmful effects are pain, swelling and fever so there should be a clear idea of intake or consultation with the health specialists (Austin et al. 2021). Potassium immediate release tablet contains cellulose microcrystalline, croscarmellose sodium, starch, sodium carboxymethyl, hydrogenated castor, silica aerogel, talc and oil. So these are the most important components of potassium immediate release tablet and these help in the formation of free diclofenac acid. It is the part of diclofenac sodium and the intake of the amount is 50 mg twice or thrice in a day to make a perfect amount of potassium immediate release tablet.
The study of the formulation of the drug, designing of it, presenting the form of manufacture and mentioning the delivery date on the body of the drug are the basic qualities of physical pharmaceutics. Bio pharmaceutics helps to examine the interrelationship between the chemical or physical properties of the drug. The surface area, salt and solvates of the drug, polymorphic form, the process and excipients of the manufacturing types are the parts of this factor. Design of the dosages are typically different from each other because there are another treatment level for each disease and the dose of every drug are also different because there is always variety the high, medium and large dosage. Production and process control the preparation of the guideline so there make the variety of every drug and it cannot be determined from the very first time because it totally depends upon the characteristic of the drug. Sterilization is the only process to eliminate and avoid the microorganisms from the drug in a proper way. Along with this, the body must be protected from the dusty environment to reduce the attack of germs in mucus membrane and skin. The performance testing of the drug depends upon the design flaws or mechanism in medical device to signify its performance level.
Free acid capsule is good for treating back aches, muscle aches, menstrual cramps, dental pain and sport injuries means any types of pain or injuries. It is the prescribed drug for this type of use and the patients always get beneficial effects after using this. Here is the clear discussion of the students who use the drug in the time of observation because it has the medical effects and the nursing and medical students can use the drug for their practical experiment. It makes their work easy because it has a very easy chemical structure which is used in the time of observation (Simões et al. 2020). Aniline and 2, 6 two chlorophenol are the raw doses to make diclofenac and it has the same effects like free acid capsule. It is an anti-inflammatory non-steroidal drug so it reduces swelling, any type of pain, joint stiffness and the problems of arthritis. But the bad effects are stomach ache, heartburn, nausea, constipation, diarrhea and headache if it is taken more than the prescribed amount.
Next one is sodium enteric coated tablet and it is also an anti-inflammatory non-steroidal drug. It is prescribed for getting the good effects on some harmful diseases like ankylosing spondylitis and arthritis, redness, swelling and headache. So it is very useful for the patient and the normal amount of intake of the drug does not have any side effects. It can help the patients who are suffering from heart disease and save the patients from the danger of heart attack (van Hoogevest et al. 2021). Free acid tablets help to control the common problems like tiredness, fainting and headache. Sodium enteric coated tablet helps to protect the drugs by maintaining the pH balance and enzymatic problems in the stomach. Potassium immediate release tablet helps to slow the reaction of any acidic chemical and reduction the harmful action by saving the gastrointestinal tract. The illustration of these three doses is not problematic because they always help to maintain the pH balance in the body and save the body from any harmful attack. For free acid tablets, the required test is nitrate silver solution test. For sodium enteric coated tablet, the presence in the extrudate of the alkalizer is the required test. For potassium immediate release tablet, ECG or electrocardiograph is the required test. For this, examiner beaker, electronic machine, solute chemicals and scanning machine are the applicable equipment to make sure of the result of the test. In these above tests, the working power, dosage limit, side effects and storing ideas are covered. The students also use sodium enteric coated tablet in their research because the chemical components of the drug are very simple. So it saves their research time and makes the perfect result in the time of research. But the side effects are itching, sweating, dizziness, drowsiness, indigestion and stomach pain.
Last one is potassium immediate release tablet and it works to reduce inflammation and relieve pain like redness and swelling. The molecular weight of potassium immediate release tablet is 295 and the molecular formula is C4H10Cl2NO2. The system of potassium immediate release tablet is something different from two other means it helps in pooling through on the upper surface of the skin, penetrating the underlying tissues on the inflamed areas to decrease swelling and relieve pain. It is also the same compound like the others because it is the form of NSAIDs. So they can use it in their experiment process to make a clear and quick result because the drug can create many problems if the compound is complex. At this time, the result cannot be perfect and easy, which loses the energy of study (Haltner?Ukomadu et al. 2019). It is beneficial to use the simple compound but there are some harmful effects of potassium immediate release tablet like heartburn, nausea, indigestion, diarrhea, drowsiness and dizziness. For this, More than 8 gram is not applicable and it can be taken 4 times a day to give better results.
Packaging is a very important part to store any type of doses because if it is not stored in a proper place and proper temperature then there is the chance of product damage. So from the first time the store keeper must be careful about it to maintain the longevity of the doses. Here the three doses are free acid capsule, sodium enteric coated tablet and potassium immediate release tablet and they all are the parts of diclofenac. Diclofenac has mainly two types, one is diclofenac potassium and other is diclofenac sodium. Here all the doses are the types of diclofenac sodium and the formula of the doses are C4H10Cl2NO2. They must be kept in a cool and dry place and the temperature should be 25°C (Harde et al. 2021). These are also kept properly for the students use because they all are the types of simple compounds. So the students get beneficial effects from this because they can give the perfect and clear results from the compounds. Firstly, the works of free acid capsule reduce swelling, any type of pain, joint stiffness and the problems of arthritis. But the side effects of free acid capsule are stomach ache, heartburn, nausea and constipation.
Secondly, the works of sodium enteric coated tablet decrease the problems of ankylosing spondylitis and arthritis, redness, swelling and headache. The disadvantages of sodium enteric coated tablet are itching, sweating, dizziness and drowsiness. Thirdly, the works of potassium immediate release tablet help to reduce inflammation and relieve pain like redness and swelling. The negative effects of potassium immediate release tablet are heartburn, nausea, indigestion and diarrhea. The packaging systems of three doses of diclofenac are discussed here properly. Free acid tablets are mainly stored in a dry room where the heat and moisture cannot come because this type of temperature increases the legibility of the tablets. Next dose is Sodium enteric coated tablet and it totally loses the work activity in direct sunlight. So it is stored in a cool temperature where the sun rays cannot reach. The storage system of Potassium immediate release tablet is the same as Sodium enteric coated tablet because it cannot work properly in high temperatures. The advantage of the packaging systems is that the cold temperature is only necessary to increase the shelf life of the drugs. But the disadvantage of the systems is that the drugs totally lose their working power if they get warm and give opposite reactions to the patient body which can have harmful effects. The required machinery for each dosage product is strip packaging, aluminum foil packaging and automatic pouch packaging machines. Here the machinery packaging systems of the doses are also presented (Gupta et al. 2018). The machinery system of packaging is easier and the results of the packaging system are better than hand packaging. But for this the storing of the doses is very important because if these doses damage before the packaging then the bad review can come from the delivery side. These doses are mainly used in the time of experiment so if there can create any type of problem in the storing and packaging system then there is a great possibility of making a wrong result of the experiment. So from the first time, the store keeper must be careful about the methods because if it is not maintained then a great loss can happen in the time of observation.
Here the discussion formulations of Diclofenac in three doses like free acid capsule, sodium enteric coated tablet and potassium immediate release tablet. The preformulation study, the formulation study, the quality control and packaging system of these doses are described here. The works of free acid capsule reduce swelling, any type of pain, joint stiffness and the problems of arthritis. But the problems of free acid capsule are stomach ache, heartburn, nausea and constipation. The benefits of sodium enteric coated tablet decrease the problems of ankylosing spondylitis and arthritis, redness, swelling and headache. The side effects of sodium enteric coated tablet are itching, sweating, dizziness and drowsiness. The good effects of potassium immediate release tablet help to reduce inflammation and relieve pain like redness and swelling. The bad effects of potassium immediate release tablet are heartburn, nausea, indigestion and diarrhea.
Journals
Austin, T.J., Comber, S., Forrester, E., Gardner, M., Price, O.R., Oldenkamp, R., Ragas, A.M. and Hendriks, A.J., 2021. The importance of over-the-counter-sales and product format in the environmental exposure assessment of active pharmaceutical ingredients. Science of The Total Environment, 752, p.141624.
Dhaval, M., Makwana, J., Sakariya, E. and Dudhat, K., 2020. Drug nanocrystals: a comprehensive review with current regulatory guidelines. Current Drug Delivery, 17(6), pp.470-482.
Drumond, N. and Stegemann, S., 2021. Better medicines for older patients: Considerations between patient characteristics and solid oral dosage form designs to improve swallowing experience. Pharmaceutics, 13(1), p.32.
Elbalkiny, H.T., Yehia, A.M., Safa'a, M.R. and Elsaharty, Y.S., 2019. Potentiometric diclofenac detection in wastewater using functionalized nanoparticles. Microchemical Journal, 145, pp.90-95.
Gupta, D., Bhatia, D., Dave, V., Sutariya, V. and Varghese Gupta, S., 2018. Salts of therapeutic agents: Chemical, physicochemical, and biological considerations. Molecules, 23(7), p.1719.
Haltner?Ukomadu, E., Sacha, M., Richter, A. and Hussein, K., 2019. Hydrogel increases diclofenac skin permeation and absorption. Biopharmaceutics & drug disposition, 40(7), pp.217-224.
Harde, M.T., Lakade, H., Kakade, N.K., Chaudhary, L.R., Gosavi, S.V., Patekar, R.R. and Choudhary, H.B., 2021. ICH Guideline in Practice: Validated Inherent Stability-Indicating HPLC-Dad Method for Simultaneous Determination of Eperisone Hydrochloride and Diclofenac Sodium in Marketed Formulation. Bull. Env. Pharmacol. Life Sci, 10, pp.108-115.
Ili?, T., Panteli?, I. and Savi?, S., 2021. The implications of regulatory framework for topical semisolid drug doses: From critical quality and performance attributes towards establishing bioequivalence. Pharmaceutics, 13(5), p.710.
Jadhav, S., Kaur, A. and Bansal, A.K., 2020. Comparison of Downstream Processing of Nanocrystalline Solid Dispersion and Nanosuspension of Diclofenac Acid to Develop Solid Oral Dosage Form. Pharmaceutics, 12(11), p.1015.
Kharel, S., Stapf, M., Miehe, U., Ekblad, M., Cimbritz, M., Falås, P., Nilsson, J., Sehlén, R. and Bester, K., 2020. Ozone dose dependent formation and removal of ozonation doses of pharmaceuticals in pilot and full-scale municipal wastewater treatment plants. Science of the Total Environment, 731, p.139064.
Lafeber, I., Ruijgrok, E.J., Guchelaar, H.J. and Schimmel, K.J., 2022. 3D Printing of Pediatric Medication: The End of Bad Tasting Oral Liquids?—A Scoping Review. Pharmaceutics, 14(2), p.416.
Russo, J., Fiegel, J. and Brogden, N.K., 2020. Rheological and drug delivery characteristics of poloxamer-based diclofenac sodium formulations for chronic wound site analgesia. Pharmaceutics, 12(12), p.1214.
Simões, A., Miranda, M., Cardoso, C., Veiga, F. and Vitorino, C., 2020. Rheology by design: A regulatory tutorial for analytical method validation. Pharmaceutics, 12(9), p.820.
Tsakalozou, E., Babiskin, A. and Zhao, L., 2021. Physiologically?based pharmacokinetic modeling to support bioequivalence and approval of generic doses: A case for diclofenac sodium topical gel, 1%. CPT: Pharmacometrics & Systems Pharmacology, 10(5), pp.399-411.
van Hoogevest, P., Tiemessen, H., Metselaar, J.M., Drescher, S. and Fahr, A., 2021. The use of phospholipids to make pharmaceutical form line extensions. European Journal of Lipid Science and Technology, 123(4), p.2000297.
Williams, H.D., Ford, L., Igonin, A., Shan, Z., Botti, P., Morgen, M.M., Hu, G., Pouton, C.W., Scammells, P.J., Porter, C.J. and Benameur, H., 2019. Unlocking the full potential of lipid-based formulations using lipophilic salt/ionic liquid forms. Advanced drug delivery reviews, 142, pp.75-90.
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