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Para que es prednisone. Prednisone |
Para que es prednisone.Prednisona
Comparison of in vitroin vivoand in silico bioavailability results of different prednisone tablet formulations to assess the feasibility of possible biowaiver. Rio de Janeiro. The immediate-release solid oral products containing very soluble and permeable drugs are candidates for the biowaiver process. This work aims to compare in vitroin silicoand in vivo data to establish if previously published prednisone oral tablet formulations are biowaiver candidates.
To achieve this goal, permeation studies were conducted on Caco-2 cells. The apparent permeability coefficient for prednisone presented a value of 3. The bioequivalence study shows that the tested and reference product was equivalent. The in silico simulations successfully predicted the pharmacokinetics of the tested and the other two formulations since they were validated with the in vivo study. Both exhibit the same plasma concentration vs. Through the in silico results, it is possible to infer that the other two formulations tested may be bioequivalent concerning the reference product.
This result may be helpful in biowaiver requesting. Toward to reduce costs and the use of human beings in bioequivalence studies, this approach could be an essential way to work in the pharmaceutical industry. El estudio de bioequivalencia muestra que el producto probado y de referencia era equivalente. In silico pharmacokinetic studies could accelerate the registration process for generic drugs applying for biowaiver.
As a biowaiver candidate, the relevance of in silico studies for BCS class I drugs is even more critical, given the regulatory scenario.
It may induce regulatory agencies to take a more in-depth view of the dissolution aspects during stability studies and how in silico previsions may help develop new projects. Pharmaceutical equivalents drug products are considered bioequivalent and, therefore, interchangeable when the bioavailability is not statistically different between the products after administration at the same dose and under similar experimental conditions in a BE study 1.
Prednisone is a glucocorticoid extensively used in clinical practice for inflammatory diseases. It has a biological half-life time of about 3. The permeability rate of prednisone in artificial phospholipid membrane is 0. In Brazil, prednisone is marketed as immediate-release oral tablets at concentrations of 20 mg and 50 mg. Numerous generic formulations of prednisone registered in the Brazilian market prove the BE with the reference product.
These tests require resources and time in the formulation development process. Thus, one of the main discussions among the academic, industrial, and regulatory arena today revolves around biowaivers. A biowaiver account that relative bioavailability or BE tests are not required for drug registration by the regulatory agency when a suitable in vitro assay could replace it 4.
The need for the pharmaceutical industry to obtain a safe tool that allows an in vitro-in vivo correlation IVIVC for a possible biowaiver is increasingly higher. The concept and application of this correlation have been focused attention on universities, pharmaceutical industries, and regulatory sectors.
The correlation of the in silico simulation with the in vitro and in vivo studies can predict the absorption, distribution, metabolism, and elimination of several drugs 5.
Biowaiver procedure could involve an evaluation through computational simulations that delineate a natural or laboratory process. However, to obtain a correlation, this software needs some active pharmaceutical ingredient API input data such as permeability rate, pKa, logP, logD, and solubility 6. Also, the in vitro results combined with in silico simulation to justify a biowaiver for etoricoxib 8.
Even though it is handy in drug bioavailability prediction in the development phase, Brazilian legislation currently does not consider the in silico results to grant exemption or replace bioequivalence studies. In a previous paper, we presented a pre-formulation study by which a prednisone raw material supplier was chosen. Tablet formulations were prepared, and a stability study was conducted to select which one should be scaled up.
Moreover, we monitored dissolution and dissolution profiles during stability study, a not common approach in pharmaceutical literature. Considering the reduction of dissolution during stability studies, it could eventually impact the in vivo performance of the product over time This work compared in vitroin silicoand in vivo data to establish if previously published prednisone oral tablet formulation is an effective candidate for the biowaiver process.
Simultaneously, this paper brings a wholly new perspective of biowaiver attempt helping to understand this process better. After 24 hours, the culture medium was removed from wells, and cells were placed in contact with a Samples were stayed connected with Caco-2 cells for 3 hours and then aspirated. Thus, the cells were treated with 2. Samples were subjected to permeability tests through Caco-2 cell monolayers during passage Cells were seeded onto polycarbonate filters 0.
This solution was used in the apical compartment donor. HBSS pH 7. Prednisone solution at Two hundred microliters of this solution were added into the apical compartment of the cell monolayer.
The apparent permeability coefficient P app was calculated using Eq. Equation 1. An open, randomized, cross-over study was conducted with two treatments, two sequences, and two periods, in which volunteers received, in each period, the test or the reference formulation. The confinement period was 24 hours. Blood samples for determination of plasma concentration of prednisolone were collected before administration and up to 24 hours later at pre-established intervals. The ACAT model describes the gastrointestinal tract like compartments considering drug unreleased drug, dissolved drug, precipitated drug and physiology luminal volume, pH, transit time characteristics.
Once integrated into the PK information, like distribution volume, clearance, and half-life time, it is possible to observe the simulated drug kinetic absorption and exposition in the gastrointestinal tract.
The software has three main input modules: compound, physiology, and pharmacokinetics. The physicochemical solubility, permeability, pKa and drug dosage form tablet, dose, particle size properties were inputted at the compound module. These data were taken from the literature or experimentally determined Table 1. The solubility data was determined in pH 1. Table 1. Input parameters used for the prednisone IR tablet absorption model.
The absorption gradient coefficient C1-C4 was used to calculate the absorption scale factors ASF and scale the effective permeability to account for absorption rate variations that differ from one compartment to another 18 In the pharmacokinetic module, the used data were obtained from the bioequivalence study of the biobatch P, as described above item 2. The best model parameters were then imported into the pharmacokinetic module to enable the in silico plasma concentration versus time data 818 Through Eq.
Equation 2. The cytotoxicity assessment was performed to determine whether concentrations of After 21 days of culture, the mean transepithelial resistance TEER of the Caco-2 cell monolayer was At minutes, prednisone permeation reached Figure 1.
The apparent permeability coefficient P app for prednisone was calculated from the mean of 5 determinations of the permeability test and presented a value of 3. The mean plasma concentration vs. The pharmacokinetic parameters analyzed in the study are described in Table 2.
Table 2. Pharmacokinetic parameters obtained from the mean plasma concentration versus prednisolone time curve. According to the estimated geometric means ratio between C max and the AUC 0-t for batches P, and R the results obtained for these parameters were Therefore, the formulations under study are bioequivalent Figure 2. Mean plasma concentration of prednisolone versus time in volunteers following a single dose administration of prednisone 20 mg tablets of biobatches P and R The absorption model was developed for prednisone biobatch P immediate-release tablet.
The fraction of the amount of drug absorbed was Table 3 presents the prednisone simulated compartmental absorption along to the GI tract. The simulated and experimental PK parameters after oral administration of 20 mg prednisone immediate-release tablets biobatch P are presented in Table 4.
The predicted outputs and bioavailability in vivo were almost similar. According to the predicted plasma concentration-time curves, the biobatch P show an in vivo performance equivalent to the reference product, as proven by the BE studies Figure 2. Table 3. Simulation of the percentage absorbed of prednisone biobatch P along with the compartments of the gastrointestinal tract. Figure 3. Plasma concentration vs. TEER values were compatible with those reported in the literature for mature monolayers 12 As previously mentioned, prednisone belongs to BCS class I.
The P app obtained in this study for this drug 3. According to Vogt and collaborators 2there are very limited studies reporting the in vitro permeability of prednisone since it is a prodrug. However, the FDA Guidance 1 states that the prodrug permeability should be measured when the conversion occurs after GI membrane permeation.
So, the results about Caco-2 cells prednisone permeability could be beneficial in a biowaiver decision. In silico absorption model for prednisone immediate-release tablet. According to the drug solubility of previous studies and permeability analyzed in this work, prednisone is highly soluble and absorbed in the intestinal tract.
The evaluation of the in vivo plasma concentration vs. It means that the drug promptly occupies the central compartment, and the plasma concentration decrease depends only on the elimination rate constant, which follows a first-order process 27 The predicted outputs and BA in vivo Table 4 suggest that the in silico absorption model based on the Table 1 data successfully simulate the in vivo bioavailability of prednisone IR tablets.
❿Para que es prednisone
Para que es prednisone -
Effect of preterm birth and antenatal corticosteroid treatment on lactogenesis II in women. Managing asthma in expectant mothers.
Treat RespirMed. NAEPP expert panel report. Managing asthma during pregnancy: recommendations for pharmacologic treatment update. J Allergy Clin Immunol. J Hand Surg Am. Pharmacokinetic parameters obtained from the mean plasma concentration versus prednisolone time curve. According to the estimated geometric means ratio between C max and the AUC 0-t for batches P, and R the results obtained for these parameters were Therefore, the formulations under study are bioequivalent Figure 2.
Mean plasma concentration of prednisolone versus time in volunteers following a single dose administration of prednisone 20 mg tablets of biobatches P and R The absorption model was developed for prednisone biobatch P immediate-release tablet.
The fraction of the amount of drug absorbed was Table 3 presents the prednisone simulated compartmental absorption along to the GI tract. The simulated and experimental PK parameters after oral administration of 20 mg prednisone immediate-release tablets biobatch P are presented in Table 4. The predicted outputs and bioavailability in vivo were almost similar. According to the predicted plasma concentration-time curves, the biobatch P show an in vivo performance equivalent to the reference product, as proven by the BE studies Figure 2.
Table 3. Simulation of the percentage absorbed of prednisone biobatch P along with the compartments of the gastrointestinal tract. Figure 3. Plasma concentration vs. TEER values were compatible with those reported in the literature for mature monolayers 12 , As previously mentioned, prednisone belongs to BCS class I. The P app obtained in this study for this drug 3.
According to Vogt and collaborators 2 , there are very limited studies reporting the in vitro permeability of prednisone since it is a prodrug. However, the FDA Guidance 1 states that the prodrug permeability should be measured when the conversion occurs after GI membrane permeation.
So, the results about Caco-2 cells prednisone permeability could be beneficial in a biowaiver decision. In silico absorption model for prednisone immediate-release tablet. According to the drug solubility of previous studies and permeability analyzed in this work, prednisone is highly soluble and absorbed in the intestinal tract.
The evaluation of the in vivo plasma concentration vs. It means that the drug promptly occupies the central compartment, and the plasma concentration decrease depends only on the elimination rate constant, which follows a first-order process 27 , The predicted outputs and BA in vivo Table 4 suggest that the in silico absorption model based on the Table 1 data successfully simulate the in vivo bioavailability of prednisone IR tablets.
Duque and co-workers successfully used the ACAT model in BA simulated of fluconazole, a BCS class I drug, showing that the prediction model was also valuable for generic and reference drugs As mentioned, the biowaiver is requested for BCS class I drugs when using immediate-release tablets.
In this context, a predictive in vitro dissolution could replace the bioequivalence study Once the in silico absorption model was developed for prednisone IR tablets, it becomes possible that the bioavailability simulation helps during the optimization of the formulation process. By evaluating the in vivo and in silico data, it is possible to infer that an in vivo study is probably unnecessary for these, suggesting the bioequivalence between the MEST 01, MEST 02, R, and biobatch P Table 4.
Previously, the dissolution tests were conducted in purified water, as recommended by the Brazilian compendia All the products that meet the requirements of the dissolution rate still showed an in silico performance equivalent to the reference product. In some cases, the in vitro dissolution method was not discriminative for the in vivo process. Al-Tabakha and co-workers evaluated different products containing amoxicillin and potassium clavulanate that was considered bioequivalent but presenting differently in vitro dissolution profiles The use of purified water as dissolution media, although recommended for quality control tests 10 , may not be adequate for evaluating pharmaceutical equivalence.
Although the results present by this study provide a biowaiver favorable data based on the in silico pharmacokinetic study and the BCS, prednisone is at the borderline of the current criteria of BCS class I. The biowaiver of prednisone must be carefully evaluated considering its indication, therapeutic index, pharmacokinetic performance, and the possibility of drug-excipients interaction 2.
Due to many marked generic products of prednisone and other class I drugs, the use of different formulation excipients could modify their dissolution and oral absorption. Therefore, in vivo bioequivalence studies are still needed. The present study evaluates the in silico bioavailability simulations comparing these data with in vivo ones in order to establish if previous published prednisone oral tablet formulation is a valid candidate for the biowaiver process. The simulated plasma concentration vs.
In order to confirm this hypothesis, a predictive dissolution study should be applied. This work turns available the bioavailability profile obtained in human volunteers and compares reference and tests drug products, which is not common in the offered publications.
More than that, it presents a viable in silico model to simplify post-approval changes in the regulatory scenario. Prednisone is classified as a BCS class I or borderline class I drug and a promising candidate for biowaiver. However, a careful evaluation of the excipients used is necessary to claim it. Food and Drug Administration. Draft Guidance. J Pharm Sci. Rio de Janeiro, Brazil: Guanabra Koogan; Waterbeend HV, Testa B.
Bioavailability: estimation of solubility, permeability, absorption and bioavailability. Dusseldorf: Wiley-UCH; Biorelevant dissolution media as a predictive tool for glyburide a class II drug. Eur J Pharm Sci. Computer simulations using GastroPlus r to justify a biowaiver for etoricoxib solid oral drug products. Eur J Pharm Biopharm. Prednisone raw material characterization and formulation development. Call your doctor if you have any unusual problems while you are taking this medication.
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture not in the bathroom.
It is important to keep all medication out of sight and reach of children as many containers such as weekly pill minders and those for eye drops, creams, patches, and inhalers are not child-resistant and young children can open them easily.
To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program.
In case of overdose, call the poison control helpline at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to prednisone. If you are having any skin tests such as allergy tests or tuberculosis tests, tell the doctor or technician that you are taking prednisone.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription over-the-counter medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements.
You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies. Generic alternatives may be available. Prednisone pronounced as pred' ni sone. Why is this medication prescribed?
How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose?
What side effects can this medication cause? What should I know about storage and disposal of this medication? Brand names. Swallow the delayed-release tablet whole; do not chew or crush it.
Prednisone is used alone or with other medications to treat the symptoms of low corticosteroid levels lack of certain substances that are usually produced by the body and are needed for normal body functioning. Prednisone is also used to treat other conditions in patients with normal corticosteroid levels. These conditions include certain types of arthritis; severe allergic reactions; multiple sclerosis a disease in which the nerves do not function properly ; lupus a disease in which the body attacks many of its own organs ; and certain conditions that affect the lungs, skin, eyes, kidneys blood, thyroid, stomach, and intestines.
Prednisone is also sometimes used to treat the symptoms of certain types of cancer. Prednisone is in a class of medications called corticosteroids. It works to treat patients with low levels of corticosteroids by replacing steroids that are normally produced naturally by the body. It works to treat other conditions by reducing swelling and redness and by changing the way the immune system works. Prednisone comes as a tablet, delayed-release tablet, as a solution liquidand as a concentrated solution to take by mouth.
Prednisone is usually taken with food one to four times a day or once every other day. Your doctor will probably tell you to take your dose s of prednisone at certain time s of day every day. Your personal dosing schedule will depend on your condition and on how you respond to treatment. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
Take prednisone exactly as directed. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor. If you are taking the concentrated solution, use the specially marked dropper that comes with the medication to measure your dose. You may mix the concentrated solution with juice, other flavored liquids, or soft foods such as applesauce.
Your doctor may change your dose of prednisone often during your treatment to be sure that you are always taking the lowest dose that works for you. Your doctor may also need to change your dose if you experience unusual stress on your body such as surgery, illness, infection, or a severe asthma attack.
Tell your doctor if your symptoms improve or get worse or if you get sick or have any changes in your health during your treatment. If you are taking prednisone to treat a long-lasting disease, the medication may help control your condition but will not cure it. Continue to take prednisone even if you feel well. Do not stop taking prednisone without talking to your doctor.
If you suddenly stop taking prednisone, your body may not have enough natural steroids to function normally. This may cause symptoms such as extreme tiredness, weakness, slowed movements, upset stomach, weight loss, changes in skin color, sores in the mouth, and craving for salt. Call your doctor if you experience these or other unusual symptoms while you are taking decreasing doses of prednisone or after you stop taking the medication. Prednisone is also sometimes used with antibiotics to treat a certain type of pneumonia in patients with acquired immunodeficiency syndrome AIDS.
Talk to your doctor about the risks of using this drug for your condition. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Your doctor may instruct you to follow a low-salt, high potassium, or high calcium diet. Your doctor may also prescribe or recommend a calcium or potassium supplement. Follow these directions carefully. Talk to your doctor about eating grapefruit and drinking grapefruit juice while you are taking this medication. When you start to take prednisone, ask your doctor what to do if you forget to take a dose.
Write down these instructions so that you can refer to them later. Call your doctor or pharmacist if you miss a dose and do not know what to do.
Do not take a double dose to make up for a missed dose. Prednisone may slow growth and development in children. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor about the risks of giving prednisone to your child. Prednisone may increase the risk that you will develop osteoporosis. Talk to your doctor about the risks of taking prednisone and about things that you can do to decrease the chance that you will develop osteoporosis.
Some patients who took prednisone or similar medications developed a type of cancer called Kaposi's sarcoma. Talk to your doctor about the risks of taking prednisone. Prednisone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication. Keep this medication in the container it came in, tightly closed, and out of reach of children.
Store it at room temperature and away from excess heat and moisture not in the bathroom. It is important to keep all medication out of sight and reach of children as many containers such as weekly pill minders and those for eye drops, creams, patches, and inhalers are not child-resistant and young children can open them easily.
To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. In case of overdose, call the poison control helpline at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at Keep all appointments with your doctor and the laboratory.
Your doctor will order certain lab tests to check your body's response to prednisone. If you are having any skin tests such as allergy tests or tuberculosis tests, tell the doctor or technician that you are taking prednisone.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription over-the-counter medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements.
You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Generic alternatives may be available. Prednisone pronounced as pred' ni sone. Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose? What side effects can this medication cause? What should I know about storage and disposal of this medication? Brand names.
Swallow the delayed-release tablet whole; do not chew or crush it. Other uses for this medicine. What special precautions should I follow? Before taking prednisone, tell your doctor and pharmacist if you are allergic to prednisone, any other medications, or any of the inactive ingredients in prednisone tablets or solutions.
Ask your doctor or pharmacist for a list of the inactive ingredients. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. John's wort. If you become pregnant while taking prednisone, call your doctor. You should carry a card or wear a bracelet with this information in case you are unable to speak in a medical emergency.
Stay away from people who are sick and wash your hands often while you are taking this medication. Be sure to avoid people who have chicken pox or measles. Call your doctor immediately if you think you may have been around someone who had chicken pox or measles.
Prednisone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: headache dizziness difficulty falling asleep or staying asleep inappropriate happiness extreme changes in mood changes in personality bulging eyes acne thin, fragile skin red or purple blotches or lines under the skin slowed healing of cuts and bruises increased hair growth changes in the way fat is spread around the body extreme tiredness weak muscles irregular or absent menstrual periods decreased sexual desire heartburn increased sweating Some side effects can be serious.
If you experience any of the following symptoms, call your doctor immediately: vision problems eye pain, redness, or tearing sore throat, fever, chills, cough, or other signs of infection seizures depression loss of contact with reality confusion muscle twitching or tightening shaking of the hands that you cannot control numbness, burning, or tingling in the face, arms, legs, feet, or hands upset stomach vomiting lightheadedness irregular heartbeat sudden weight gain shortness of breath, especially during the night dry, hacking cough swelling or pain in the stomach swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs difficulty breathing or swallowing rash hives itching Prednisone may slow growth and development in children.
What other information should I know? Browse Drugs and Medicines.
¿Qué es este medicamento? La PREDNISONA trata muchas afecciones tales como asma, reacciones alérgicas, artritis, enfermedades intestinales inflamatorias. Para que sirve el medicamento bersen prednisone 20 mg. Prednisone is a corticosteroid and short-acting bronchodilator that is used to treat conditions such. Para que sirve el jarabe bersen prednisone 20 mg. Effects of from $ for dose prednisone 20 mg non prescription. Prednisolone se usa en el tratamiento de varias diferentes condiciones, como la artritis, lupus, psoriasis, colitis ulcerativa, trastornos de alergias. La prednisona (Deltasone) forma parte de una potente clase de agentes antiinflamatorios, conocidos como corticosteroides, que. The confinement period was 24 hours. Prednisone is in a class of medications called corticosteroids. Prednisone is classified as a BCS class I or borderline class I drug and a promising candidate for biowaiver. In vitro-in vivo correlation: From theory to applications. Ask your pharmacist any questions you have about refilling your prescription. Your doctor will probably tell you to take your dose s of prednisone at certain time s of day every day.Corticoides orales. Riesgo Se excreta en leche materna en cantidades no significativas y no se han observado problemas en lactantes de madres que lo tomaban incluso por periodos prolongados de tiempo a dosis de hasta 10 mg diarios.
Nivel 0: Riesgo muy bajo. Compatible y sin riesgo para la lactancia y el lactante. Rheumatoid arthritis medications and lactation. Curr Opin Rheumatol.
Review article: a decision-making algorithm for the management of pregnancy in the inflammatory bowel disease patient. Aliment Pharmacol Ther. European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohns Colitis. Inflammatory bowel disease and pregnancy: report of two cases treated with infliximab and a review of the literature.
Eur J Gastroenterol Hepatol. Effect of preterm birth and antenatal corticosteroid treatment on lactogenesis II in women. Managing asthma in expectant mothers. Treat RespirMed. NAEPP expert panel report. Managing asthma during pregnancy: recommendations for pharmacologic treatment update. J Allergy Clin Immunol. J Hand Surg Am. American Academy of Pediatrics Committee on Drugs.
Transfer of drugs and other chemicals into human milk. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Intern Med.
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