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09/Aug/2021

Duloxetine HCL

Overview

Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-?-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS•HCl. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water.

Primary Characteristics

Duloxetine Hydrochloride is of Synthetic origin. . The Molecular Weight of Duloxetine Hydrochloride is 333.90. It is weakly alkaline drug.

 

Indications

Indicated for:

1) Management of Major Depressive Disorder.

2) Management of Generalized Anxiety Disorder.

3) Management of diabetic peripheral neuropathy.

4) Management of fibromyalgia.

5) Management of chronic musculoskeletal pain.

6) Management of osteoarthritis of the knee in adults.

7) Management of chronic lower back pain in adults.

8) Management of stress urinary incontinence in adult women.

Off-label uses include:

1) Management of chemotherapy-induced peripheral neuropathy.

2) Management of stress urinary incontinence in adult men after prostatectomy until recovery is complete.

Pharmacodynamics

Duloxetine, through increasing serotonin and norepinephrine concentrations in Onuf’s nucleus, enhances glutamatergic activation of the pudendal motor nerve which innervates the external urethral sphinter. This enhanced signaling allows for stronger contraction. Increased contraction of this sphincter increases the pressure needed to produce an incontinence episode in stress urinary incontinence. Duloxetine has been shown to improve Patient Global Impression of Improvement and Incontinence Quality of Life scores. It has also been shown to reduce the median incontinence episode frequency at doses of 40 and 80 mg.

Action at the dorsal horn of the spinal cord allows duloxetine to strengthen the the serotonergic and adrenergic pathways involved in descending inhibition of pain. This results in an increased threshold of activation necessary to transmit painful stimuli to the brain and effective relief of pain, particularly in neuropathic pain. Pain relief has been noted in a variety of painful conditions including diabetic peripheral neuropathy, fibromyalgia, and osteoarthritis using a range of pain assessment surveys. While duloxetine has been shown to be effective in both animal models of mood disorders and in clinical trials for the treatment of these disorders in humans, the broad scope of its pharmacodynamic effects on mood regulation in the brain has yet to be explained.

Mechanism of action

Duloxetine is a potent inhibitor of neuronal serotonin and norepinephrine reuptake and a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors.

Action on the external urinary sphincter is mediated via duloxetine’s CNS effects. Increased serotonin and norepinephrine concentrations in Onuf’s nucleus leads to increased activation of 5-HT2, 5-HT3, and α1 adrenergic receptors. 5-HT2 and α1 are both Gq coupled and their activation increases the activity of the inositol trisphosphate/phospholipase C (IP3/PLC) pathway. This pathway leads to release of intracellular calcium stores, increasing intracellular calcium concentrations, and facilitating neuronal excitability. 5-HT3 functions as a ligand-gated sodium channel which allows sodium to flow into the neuron when activated. Increased flow of sodium into the neuron contributes to depolarization and activation of voltage gated channels involved in action potential generation. The combined action of these three receptors contributes to increased excitability of the pudendal motor nerve in response to glutamate

Duloxetine side effects

The severe or irreversible adverse effects of Duloxetine Hydrochloride, which give rise to further complications include Hyponatremia, Hyponatremia.

The symptomatic adverse reactions produced by Duloxetine Hydrochloride are more or less tolerable and if they become severe, they can be treated symptomatically, these include Weakness, Thirst, Fatigue, Nausea, Vomiting, Diarrhea, Constipation, Insomnia, Sweating, Blurred vision, Pruritus, Lethargy, Dyspepsia, Weight gain, Somnolence, Tremor, Sexual dysfunction, Syncope, Decrease in libido, dyspepsia.

 


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05/Aug/2021

Lansoprazole

 

Overview

Lansoprazole is an acid proton pump inhibitor. Lansoprazole is a benzimidazole sulfoxide derivative and produces long lasting inhibition of gastric acid secretion. Lansoprazole is a chiral compound with one chiral center, synthsized as a racemic mixture and both enantiomers are active. Chemically Lansoprazole is identified as 2-[[[3-methyl-4-(2, 2, 2-trifluoroethoxy)-2-pyridinyl] methyl] sulfinyl ]-1H-benzimidazole. Lansoprazole is effective in the treatment of duodenal or gastric ulcer, gastroesophageal reflux disease and in the treatment of zollinger-ellison syndrome. Lansoprazole is administered orally.

Primary Characteristics

It is of Synthetic origin and belongs to Sulphinyl Benzimidazole. It belongs to H/K Atpase proton pump inhibitor pharmacological group on the basis of mechanism of action and also classified in Antacids pharmacological group. The Molecular Weight of Lansoprazole is 369.00.

Its pKa is 8.85.

 

Indications

Lansoprazole is primarily indicated in conditions like Acid-related dyspepsia, Benign gastric ulcer, Duodenal ulcer, Duodenal ulcer associated with h. Pylori, Esophagitis, Gastric ulcer, Gastro-esophageal reflux disease, Heart burn, Helicobacter pylori positive duodenal ulcer, NSAID-associated gastric and duodenal ulcers, NSAID-associated gastric and duodenal ulcers (prophylaxis), NSAID-associated gastric or duodenal ulcers, Peptic ulcer, Resistant ulcers, Zollinger-ellison syndrome, and can also be given in adjunctive therapy as an alternative drug of choice in GI bleeding.

 

Pharmacokinetics

Oral absorption of Lansoprazole is found to be 40% ±40. Volume of distribution is found to be 24 ± 8 liter and plasma proteins binding is 97-99%. and metabolism is reported Hepatic(extensively). Renal Excretion accounts for 30% and plasma half life is 1-2 hr.

Pharmacodynamics

Lansoprazole decreases gastric acid secretion by targeting H+,K+-ATPase, which is the enzyme that catalyzes the final step in the acid secretion pathway in parietal cells.  Conveniently, lansoprazole administered any time of day is able to inhibit both daytime and nocturnal acid secretion. The result is that lansoprazole is effective at healing duodenal ulcers, reduces ulcer-related pain, and offers relief from symptoms of heartburn  Lansoprazole also reduces pepsin secretion, making it a useful treatment option for hypersecretory conditions such as Zollinger-Ellison syndrome.

Mechanism of action

As a PPI, lansoprazole is a prodrug and requires protonation via an acidic environment to become activated.  Once protonated, lansoprazole is able to react with cysteine residues, specifically Cys813 and Cys321, on parietal H+,K+-ATPase resulting in stable disulfides. PPI’s in general are able to provide prolonged inhibition of acid secretion due to their ability to bind covalently to their targets.

 

 Side Effects

The severe or irreversible adverse effects of Lansoprazole, which give rise to further complications include Atrophic gastritis, Epidermal necrolysis.

The symptomatic adverse reactions produced by Lansoprazole are more or less tolerable and if they become severe, they can be treated symptomatically, these include Headache, Nausea, Diarrhea, Constipation, Rashes, Pruritus.

 

Interference in Pathology

  • Elevations of SGPT and SGOT
  • Abnormal LFTs
  • Increased Alkaline Phosphatase Levels
  • Elevation in ALT or AST
  • Increased in serum creatinin

 


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02/Aug/2021

Itraconazole

Overview

Itraconazole is a broad-spectrum antifungal agent for oral treatment of vulvovaginal candidiasis, pityriasis versicolor and dermatophytes. Itraconazole is a substituted triazole derivative. Itraconazole active works against many Candida species, endemic mycoses and dermatophytes. Itraconazole is the most potent of available azoles, but effectiveness can be limited by reduced bio availability. The requirement for intravenous administration and the toxicity of the older antifungal agents created a need for antifungal agents with a better therapeutic profile. The relatively non-toxic oral azole medications represent the first major advance in this direction. Since their introduction in the 1980s, these medications have played an increasingly important role in the systemic therapy of fungal diseases.

Primary Characteristics

Itraconazole is also known as Oriconazole. It is of Synthetic origin and belongs to Triazole. It belongs to Antifungals pharmacological group. The Molecular Weight of Itraconazole is 705.60.

Its pKa is 3-4.

Indications

Itraconazole is primarily indicated in conditions like Advanced breast or prostate cancer, Antifungal prophylaxis, Candidiasis, Cryptcoccal meningitis, Dermatophytic infections, Histoplasmosis, Oculomycoses, Onychomycoses, Oral candidiasis, Oropharangeal candidiasis, Orophyrangeal candidiasis, Pityriasis versicolor, Sporotrichosis, Superficial candidiasis, Systemic mycoses, Tinea pedis, Tinae manuum, To reduce intestinal secretions and vomiting, To reduce intestinal secretions and vomiting (palliative care), and can also be given in adjunctive therapy as an alternative drug of choice in Cushing`s syndrome due to malignant disease, Fungal keratitis, Leishmaniasis, Vulvo-vaginal candidosis.

 

Pharmacokinetics

Oral absorption of Itraconazole is found to be 42.5% ±42.5. Volume of distribution is found to be 10.7 l/kg and plasma protien binding is 99.8%. Presystemic metabolism is noted to be 22.5% ±22.5 and metabolism is reported Hepatic. Renal Excretion accounts for 40% (inactive metabolite) and plasma half life is 20 hr.

 

Mechanism of action

Itraconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Itraconazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis

 

Side Effects

The severe or irreversible adverse effects of Itraconazole, which give rise to further complications include Hypotension, Hepatitis, Hypotension.

Itraconazole produces potentially life-threatening effects which include Dysrhythrics. which are responsible for the discontinuation of Itraconazole therapy.

The signs and symptoms that are produced after the acute overdosage of Itraconazole include Constipation, Gastritis, Depression.

The symptomatic adverse reactions produced by Itraconazole are more or less tolerable and if they become severe, they can be treated symptomatically, these include Dizziness, Vertigo, Headache, Fatigue, Nausea, Vomiting, Diarrhea, Abdominal pain, Pruritus, Hallucination, Somnolence, Hair loss, Edema, Photophobia, Vasculitis, dizziness.

 

Warning / Precautions

Itraconazole should be used with caution in patients with liver disease, heart rhythm disorders (arrhythmias) and of any drug allergies. It should be used with caution while engaging in activities requiring alertness because this medication causes dizziness or drowsiness. It should be used only when clearly needed during pregnancy or lactation. Safe use of itraconazole in the children under the age 16 has not been established. The drug should be used with caution in the patients with azole hypersensitivity. Patients who develop abnormal liver function tests during itraconazole therapy should be monitored and therapy discontinued if symptoms of the liver disease develop. Should not be administered to treat onchonycosis in pateints with ventricular dysfurution.

 

Storage Conditions

Capsules:

Store Between 15°C-30°C. Protect from Sunlight, Moisture and Heat.

Solution:

Store at room temperature, Below 25°C. Do not Freeze. Protect from Sunlight and Heat.

 

Interference in Pathology

Elevated liver enzymes

 


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29/Jul/2021

Azithromycin

The antimicrobial agents or antibiotics develops during the last 60 years are among the most dramatic examples of the advances of science. The remarkably powerful and specific activity of antimicrobial drug is due to their selectivity for highly specific targets that are either unique to micro-organism or much more important in them than in humans. Azithromycin belongs to a macrolide antibiotic. Azithromycin is a 15-atom lactone macrolide ring compound. Azithromycin is a semisynthetic derivative of Erythromycin obtained by the addition of methylated nitrogen into the lactone ring of Erythromycin. Azithromycin is effective against gram positive bacteria. Antibiotics require constant drug level in body for therapeutic effect. This is achieved by taking the medication at regular interval of time throughout the day and night as prescribed. Azithromycin is important to take the drug for the full time period as prescribed. If you discontinue the therapy, it may result in ineffective treatment.

Primary Characteristics

It is of Semi Synthetic origin and belongs to Azalide. It belongs to Antibacterial (Protein synthesis inhibitor) pharmacological group on the basis of mechanism of action and also classified in Antibiotics pharmacological group. The Molecular Weight of Azithromycin is 785.00.

Indications

Azithromycin is primarily indicated in conditions like Cervicitits, Lower respiratory tract infections, Multiple myeloma, Otitis media, Reversal of excessive bradycardia, Rtis, otitis media, Skin and soft tissue infections, Soft tissue and skin infections, Status epilepticus (unlicensed use), Upper respiratory tract infections, Urethritis.

 

Pharmacokinetics

Oral absorption of Azithromycin is found to be 34% ±19. Volume of distribution is found to be 31.1 l/kg and plasma proteins binding is 51%. Renal Excretion accounts for < 10% unchanged. Also excreted in bile and plasma half life is 68%.

 

Contraindications

Azithromycin is contraindicated in conditions like Hepatic impairment, Hypersensitivity.

 

Drug Interactions

Azithromycin is known to interact with other drugs, the details of drug interactions is as follows:

Severity

Triazolam, Aluminium Hydroxide and Oxide, Cyclosporin,  Terfenadine, Theophylline, Ergotamine (Tartrate), Ibrutinib

Moderate

Astemizole, Digoxin.

These interactions are sometimes beneficial and sometimes may pose threats to life. Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

 

Side Effects

The severe or irreversible adverse effects of Azithromycin, which give rise to further complications include Maculopapular rash, Cholestasis, Pseudomembranous colitis, Jaundice.

Azithromycin produces potentially life-threatening effects which include Anaphylaxis, Angioneurotic edema. which are responsible for the discontinuation of Azithromycin therapy.

The signs and symptoms that are produced after the acute over dosage of Azithromycin include severe nausea, Severe diarrhoea, Severe vomiting, Hearing loss.

The symptomatic adverse reactions produced by Azithromycin are more or less tolerable and if they become severe, they can be treated symptomatically, these include Flatulence, Dizziness, Vertigo, Headache, Fatigue, Nausea, Vomiting, Diarrhoea, Palpitation, Abdominal pain, Rashes, Photosensitivity, Deafness, GI disturbance.

 

High Risk Groups

Drug should not be given to Pregnant Mothers, patients suffering from Kidney dysfunction, patients suffering from Liver Malfunction, and Neonates.

If prescribing authority justifies the benefits of the drug against the possible damages he/she should re-evaluate them and consult the reference material and previous +

studies.

 

Warning / Precautions

Azithromycin should be used with caution in patients with illness or any allergy, especially allergies to drugs, liver disease, jaundice, history of colitis or stomach problems or kidney disease. This drug should be used only if clearly needed during pregnancy or lactation.

 

Storage Conditions

Tab, Caps, Oral Suspension

Store Below 40°C. Protect from Sunlight and Moisture.

 

Interference in Pathology

The use of Azithromycin may show false elevated serum aspartate.

 


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26/Jul/2021

Clarithromycin

Clarithromycin is a macrolide antibiotic. Macrolides are compounds characterized by a macrocyclic lactone ring to which deoxy sugars are attached. Clarithromycin is a semisynthetic derivative of Erythromycin obtained by the addition of methyl group to hydroxyl group at carbon 6. Clarithromycin is effective against gram positive bacteria. Antibiotics require constant drug level in body for therapeutic effect. This is achieved by taking the medication at regular interval of time throughout the day and night as prescribed. Clarithromycin is important to take the drug for the full time period as prescribed. If you discontinue the therapy, it may result in ineffective treatment.

Primary Characteristics

clarithromycin is of Semi Synthetic origin and belongs to Hexopyranosyl. It belongs to Antibacterial (Proetin synthesis inhibitor) pharmacological group on the basis of mechanism of action and also classified in Antibiotics pharmacological group. The Molecular Weight of Clarithromycin is 748.00.

 

Indications

Clarithromycin is primarily indicated in conditions like Chronic bronchitis, Metastatic germ cell cancer, Mycobacterial infection, Otitis media, Pharyngitis, Pneumonia, Respiratory tract infections, Rtis, otitis media, Sinusitis, Skin infections, Soft tissue infections, To counteract the folate-antagonist action of methotrexate, Tonsillitis, and can also be given in adjunctive therapy as an alternative drug of choice in Duodenal ulcer, Endocarditis.

Pharmacokinetics

Oral absorption of Clarithromycin is found to be 50% ±50. Volume of distribution is found to be 250 litre and plasma protien binding is 80%. Presystemic metabolism is noted to be 20% ±20 and metabolism is reported via liver. Renal Excretion accounts for 20-30%(unchanged) 10-15%(metabolite) and plasma half life is 2.9-9.2 hr.

 

Pharmacodynamics

Clarithromycin is a macrolide antibiotic whose spectrum of activity includes many gram-positive (Staphylococcus aureus, S. pneumoniae, and S. pyogenes) and gram-negative aerobic bacteria (Haemophilus influenzae, H. parainfluenza, and Moraxella catarrhalis), many anaerobic bacteria, some mycobacteria, and some other organisms including Mycoplasma, Ureaplasma, Chlamydia, Toxoplasma, and Borrelia. Other aerobic bacteria that clarithromycin has activity against include C. pneumoniae and M. pneumoniae. Clarithromycin has an in-vitro activity that is similar or greater than that of erythromycin against erythromycin-susceptible organisms. Clarithromycin is usually bacteriostatic, but may be bactericidal depending on the organism and concentration of drugs.

Mechanism of action

Clarithromycin is first metabolized to 14-OH clarithromycin, which is active and works synergistically with its parent compound. Like other macrolides, it then penetrates bacteria cell wall and reversibly binds to domain V of the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome, blocking translocation of aminoacyl transfer-RNA and polypeptide synthesis. Clarithromycin also inhibits the hepatic microsomal CYP3A4 isoenzyme and P-glycoprotein, an energy-dependent drug efflux pump.

 

Side Effects

The severe or irreversible adverse effects of Clarithromycin, which give rise to further complications include Renal failure, Interstitial nephritis, Pseudomembranous colitis.

Clarithromycin produces potentially life-threatening effects which include cerebial hemorrhage. which are responsible for the discontinuation of Clarithromycin therapy.

The signs and symptoms that are produced after the acute overdosage of Clarithromycin include Hypoxia, Hypokalemia.

The symptomatic adverse reactions produced by Clarithromycin are more or less tolerable and if they become severe, they can be treated symptomatically, these include Headache, Nausea, Vomiting, Diarrhea, Abdominal pain, Phlebitis, Glossitis, StomatitisX, Elevation of liver enzymes, Taste perversion, Increased intracranial pressure, Hypoglycemia.

Warning / Precautions

Clarithromycin should be used with caution in patients with other illnesses or any allergy, especially allergies to drugs, arrythmias ,liver disease, jaundice (yellowing of the skin or eyes), kidney disease , or a history of colitis or stomach problems. This drug should be used only if clearly needed during pregnancy or lactation.

 

Storage Conditions

Oral suspension (reconstituted)

Store at room temperature. Refrigeration and Freezing is not recommended. Protect from Sunlight. Use within 14 days if kept at room temperature.

Tablets:

Store in a well closed container, Below 40°C. Protect from Sunlight and Moisture.

 

Interference in Pathology

Elevations of SGPT and SGOT

Alkaline phosphatase levels are elevated.

Serum creatinine raised.

Interference with serum aspartate amino transferase, urinary catecholamine and 17- hydroxy corticosteroids.

 


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13/Jul/2021

Omeprazole

Omeprazole is a an oral antiulcer agent. Omeprazole is characterized as a gastric acid pump inhibitor because it blocks the final step of gastric acid production. It has a long duration of action and is very potent, allowing for once-daily administration. Despite its potency, it must be used in combination with antibiotics to be effective against Helicobacter pylori. Due to concern regarding long-term use, it was originally approved by the FDA in September 1989 for acute treatment only. In December 1994, an FDA advisory committee recommended it be approved for maintenance therapy of healed erosive esophagitis. In April 1996, it was approved for the treatment of H. pylori-associated duodenal ulcer. Belongs to a new class of ant secretory agents, the substituted benzimidazoles, which suppress gastric acid secretion by inhibiting the H+/K+ ATPase enzyme system of parietal cells. it, following activation in an acidic pH, binds irreversibly to the H+/K+ ATPase pump on the secretory surface of the parietal cell membrane. Subsequently, the secretion of hydrogen ions into the gastric lumen is inhibited. it inhibits both basal and stimulus-induced acid secretion.

Primary Characteristics

Omeprazole is also known as Proton pump Inhibitor. It is of Synthetic origin and belongs to Benzimidazol. It belongs to H/K At pase proton pump inhibitor pharmacological group on the basis of mechanism of action and also classified in Antacids pharmacological group. The Molecular Weight of Omeprazole is 345.40.

Its pKa is 4.0, 8.7.

Indications

Omeprazole is primarily indicated in conditions like Acid reflux disease (long-term management), Benign gastric and duodenal ulceration, Benign gastric and duodenal ulcers, Benign gastric ulcer associated with H.pylori, Duodenal errosions, Duodenal or benign gastric ulcer associated with H.pylori, Duodenal ulcer, Duodenal ulcer associated with h. Pylori, Gastric acid reduction during anaesthesia, Gastric acid reduction during general anesthesia, Gastric ulcer, Gastro-esophageal reflux disease, Gastro-o esophageal reflux disease, Gastro-esophageal reflux disease (refractory to other treatment), Maintenance of recurrent duodenal ulcers, Non-ulcer dyspepsia, NSAID-associated gastric and duodenal ulcers, NSAID-associated gastric and duodenal ulcers (prophylaxis), NSAID-associated gastric and duodenal ulcers and duodenal erosions, NSAID-associated gastric or duodenal ulcers, NSAID-associated gastric or duodenal ulcers (prophylaxis), Prevention of relapse in duodenal ulcer, Prophylaxis for NSAID-associated gastric and duodenal ulcers, Prophylaxis of acid aspiration, Reflux esophagitis, Resistant ulcers, Severe or recurrent duodenal and gastric ulceration, Zollinger-Ellison syndrome, and can also be given in adjunctive therapy as an alternative drug of choice in Acid aspiration syndrome prevention, GI bleeding.

 

Pharmacokinetics

Oral absorption of Omeprazole is found to be 57.5% ±7.5. Volume of distribution is found to be 0.3 – 0.4 l/kg and plasma proteins binding is 95%. Pre systemic metabolism is noted to be 20% and metabolism is reported Hepatic. Renal Excretion accounts for 80% and plasma half life is 1 hr.

 

Mechanism of action

Hydrochloric acid (HCl) secretion into the gastric lumen is a process regulated mainly by the H(+)/K(+)-ATPase of the proton pump , expressed in high quantities by the parietal cells of the stomach. ATPase is an enzyme on the parietal cell membrane that facilitates hydrogen and potassium exchange through the cell, which normally results in the extrusion of potassium and formation of HCl (gastric acid) .

Omeprazole is a member of a class of anti secretory compounds, the substituted benzimidazoles, that stop gastric acid secretion by selective inhibition of the H+/K+ ATPase enzyme system. Proton-pump inhibitors such as omeprazole bind covalently to cysteine residues via disulfide bridges on the alpha subunit of the H+/K+ ATPase pump, inhibiting gastric acid secretion for up to 36 hours . This anti secretory effect is dose-related and leads to the inhibition of both basal and stimulated acid secretion, regardless of the stimulus .

Mechanism of H. pylori eradication

Peptic ulcer disease (PUD) is frequently associated with Helicobacter pylori bacterial infection (NSAIDs) . The treatment of H. pylori infection may include the addition of omeprazole or other proton pump inhibitors as part of the treatment regimen. H. pylori replicates most effectively at a neutral pH . Acid inhibition in H. pylori eradication therapy, including proton-pump inhibitors such as omeprazole, raises gastric pH, discouraging the growth of Pylori . It is generally believed that proton pump inhibitors inhibit the urease enzyme, which increases the pathogenesis of H. pylori in gastric-acid related conditions .

 

Side Effects

The severe or irreversible adverse effects of Omeprazole, which give rise to further complications include Interstitial nephritis.

Omeprazole produces potentially life-threatening effects which include Anaphylaxis. which are responsible for the discontinuation of Omeprazole therapy.

The signs and symptoms that are produced after the acute over dosage of Omeprazole include Tachycardia, Drowsiness, Drowsiness, Headache.

The symptomatic adverse reactions produced by Omeprazole are more or less tolerable and if they become severe, they can be treated symptomatically, these include Flatulence, Dizziness, Headache, Fatigue, Nausea, Diarrhea, Myalgia, Constipation, Insomnia, Abdominal pain, Dry mouth, Urticaria, Pruritus, Photosensitivity, Skin rash, Impotence, Depression, Arthralgia, Myopathy, Gynecomastia, Agitation, Dry mouth, dizziness.

 


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06/Nov/2020

Drug Pellet formation may appear as semicircular granules to an unaided eye. But is it the same plain, old, bitter tastings medicinal stuff, nay! It indeed a marvelous of modern pharmaceutical research. We at Vision Pharmaceutical put literally our heart and soul with critical Thinking brains and expert hands into making drug palletization a reality and its wider availablity to local as well as international consumers.

Vision Pharmaceutical with its focused and result oriented R&D makes the formation of nearly spherical particles into final, pellitized product possible undergoing the process of fine particulating ,tumble drying, addition of binders and additives in various pellitization equipment.

Our unique pellitization techniques make us not only on par with any standardized international pellet manufacturers but give us un upper hand in economically competitive market as well. Drug Pellets manufacturing an art in itself and undergoes stages of production under uber scientific principles. What factors work deep down in these processing and how complicated it  ,let us have a look.

At first moist content of dried particles is reduced to form an effective air water interface. Make a granulation of particles possible with the help of both physical and applied forces. Physical forces impart tensile strength and liquid bridging among particles, changing capillary and surface tension of granules.

At Vision Pharmaceutical purpose built fully automated manufacturing unit makes tumbling motion of the particles possible and applied forces.   That arise as a result bring individual wetted particles close to each other and uniform distribution of active ingredients. This mechanism makes it possible to initiate pellitization process and subsequent growth of individual pellets under the following factors.

  1. Nucleation

Nucleation the Formation of nuclei and the process of particles formation from the continuos phase via interaction within the physical environment. In this stage liquid bridges created making formation of three dimensional water-air-liquid bonding possible, this give particles specific physical appearance and properties. Vision Pharmaceuticals makes sure that particles size must kept smaller for better bonding strength.

  1. Coalescence:

The second stage is coalescence, its a transition stage. This region affected by growth factors of coalescence and drug layering. Very important indeed so it needs to be closely supervised and Our R&D strives to make the process up to date. Coalescence brings discreet changes to size and no of particles but not to their mass.

  1. Layering

Layering is a third and final factor in manufacturing process of pellet formation. It is a continuous phase where both size and properties of particulate matter changes with drug layering. Vision Pharmaceutical advanced, fully automated production facility. Makes its possible to layer single or multiple active drugs on a single granule. Masking of bitter tastings drugs with addition of layers of Tasteless additives also ensured in this process.

All these Physical and Chemical processes work simultaneously in delicate ways to make scientifically quantified, tasteless, single/multi ingredient active drug pellets a reality and Vision as a pioneer in the science of pellitization.


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06/Nov/2020

Vision Pharmaceutical has one of a kind, state of art production machinery. That unique in its own way and utilise every modern pellitization Techniques, a quality unmatched in local market as well as neighbouring India. A Vision Pharmaceutical fully automated plant, R&D and Quality control department work in synchronisation to produce products with unmatched quality, economy, efficacy and Heartfelt satisfaction from our end consumers.

Vision Pharmaceutical utilises every modern standardised technique and pharmaceutical manufacturing procedures to produce drug pellets of unmatched quality.

We herby Discuss Vision Pharma’s pellitization Techniques in detail.

Extrusion Spheronization:

This technique widely used in modern pellitization worldwide. Vision Pharmaceutical utilises it as a major pellitization procedure in its operations. Our unique extrusions Spheronization takes place in three steps.

. Feed preparation

. Pellets production

. Pellets curing

Feed preparation, the first step and it initiated by mixing of drug-excipients with desired additives such as solution of binding agents. Then the second and most important step follows, and the process of agglomeration, where desired size of pellets are formed in pellitizater. The final step curing of wet pellets by thermal drying. Vision Pharmaceutical also utilises technique of simple stockpiling for some drug pellets.

The pellitization begins with the dispensing of powder feed material with binding solutions to the granulator to form a plasticized wet mass. This mass allowed to the screening chamber of extruder. Here pressure blades provide enough Compression to wet mass against the exterior of the screen. The extruder material discharged into discharge unit through scrapper blade and then finally into Spheronizer. Pellitizer disk  rolls the extruded with high speed in the direction of the roller and a rolling movement of helical like structure takes place. This makes the extrudes smooth in short amount of time. Due to intense rolling action and finally uniformed and spherical pellets discharged at the discharge unit.

More about Pellitization Technique

Pellitization Technique needs careful evaluation and continuous monitoring.  Vision Pharmaceutical’s production and quality control departments keep a keen eye. Monitors and document the whole process according to strict guidelines at every step of production. We ensure that every step thoroughly followed and not even a slight mistake is tolerated. We at Vision ensure that.

. In order to produce pellets of uniform size and shape the whole procedure of spheronization properly optimized.

. Extrudate should be in proper wet condition before entering spheronizer. So that it can be spheronized smoothly and no further breakdown occur.

. Different types of extruders are used for different formulations in order to achieve uniform pellitization.

. Amount of binders strictly controlled to avoid hardness and irregular shapes of pellets.

. Formation of big lumps of pellets  avoided at every cost.

. This type of pellitization process  more labor intensive but result in very ideal uniform shaped also spherical pellets.


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06/Nov/2020

Another common pellitization technique employed by Vision Pharmaceutical layering technique. This production technique predominantly used for taste masked and control release formulations. This technique of two types, solution layering and powder layering.

In solution layering powder feed material and other components dissolved in solvent. Then this solution or suspension sprayed on the starter core and spread evenly on the surface. Spraying follow by drying phase, in this phase dissolved material get crystallized and solid bridges formed between drug and polymers. Vision Pharmaceutical controls drying method very strictly because drying can affect structural and functional properties of pellets. Various techniques employed by Vision Pharmaceutical’s production unit to increase dissolution properties of pellets.

In powder layering the seeds charged into the pellitizer and on its surface. Then the binder liquid and powder feed material sprayed tangentially. The uniform distribution of powder over the seed surface ensured by rolling movement confirming its spherical shape. It involves uniform deposition of fine drug particles plus excipients on the surface of starting core with the help of binding liquid.

Vision Pharmaceutical never use conventional coating pan ( used by many pellet’s manufacturers even today) due to its limitations, like poor degree of mixing and very inefficient drying. We employ procedures that deliver the powder in such a manner and rate that in equilibrium with the binder liquid application rate throughout the process. We at Vision make sure that no over wetting and dust generation occur as it will reduce the overall quality and yield of products.

Fluidized Bed Processor:

Also called Wurster process, it performs multiple function like coating, drying, granulations and pellitization. Vision Pharmaceutical prepares control release formulations by this technique particularly.

It involves successive deposition of several layers of the coating material. A spray nozzle fitted in the base plate with concurrent air flow and pressurised stream of specific spray pattern. The particles accelerated within the Wruster tube and coating material continuosly sprayed through the spray case. The process continues till appropriate build up on the surface of particles takes place.

Vision Pharmaceutical controls critical parameters in order to avoid powder adherence to side of hopper and if the bed temperature high and there a risk of powder lost to exhaust system. binders consistently used during solution Layering to impart strenght to the pellets.

Our Quality Control parameter ensured that our consumers get best form of sustained released, and taste masked drug pellets.


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06/Nov/2020

Vision Pharmaceutical with its unique and state of the art production and quality control techniques takes pride in unparalleled satisfaction of its end consumers through highest standard product portfolio and goal oriented business module. Here Quality control procedures followed at every stage  of production line and final product bring under strict scrutiny.

Vision Pharmaceutical manufacture drug Pellets through its automated plant and evaluate them through various standardized technique. Only pellets that pass through these evaluation measures allowed distribution to market.

Pellet Shape:

We at Vision Pharmaceutical strive to keep our pellets shape uniform and in accordance with international standards. Prime requirements for successful coating spherical and smooth shape of pellets. Both microscopic and non microscopic methods are used to determine Pellets’ shape. Pellet Shape affects its geometric properties, flow and compaction. It possible to determine whether the pellet spherical or asymmetrical. Spherical shaped pellets have minimum surface volume per unit area. The minimum face value is 6 for spherical shape Pellets, if the value exceeds 6 then the pellet is considered asymmetrical.

Size Distribution:

Pellet size equally important factor in addition to shape. Pellet size determined by sieve shaking method and microscopy. Vision Pharmaceutical commonly use sieve shaking method for evaluation of pellet size but microscopic measurements also used whenever need arises.

Surface Morphology:

Surface morphology is another very important parameter in pellets manufacturing. Scanning as well as analysis of cross section of pellets can use to determine surface morphology. Microscopic properties of pellets, structure of pellets’ surface, density and frictional force between the pellets are parameters of utmost importance. Vision Pharmaceutical ensures to impart optimal morphological properties to its manufactured pellets in order to give these ,ideal compression, and disintegration properties.

Tensile strength:

Tensile strength is very important property of drug pellets. In order to evaluate the tensile strength of pellets, Vision Pharmaceutical uses tensile apparatus. Pellets strained under five kg load cell until failure occur. Then tensile strength of that particular drug pellets calculated by using various formula specifically devised by our quality control department.

Crushing strength:

The crushing strength is the measure of load needed to break the pellet. We at Vision Pharmaceutical use material testing machine to measure crushing strenght of various drug Pellets. This process repeated at every step of production line and at end product along with other quality control tests.

Specific Surface Area:

Surface per unit volume called specific surface area. Size and shape of pellets directly affected by this physical property alone. For film coating of pellets, knowledge of specific area is extremely important, but even for uncoated pellets  it has got some importance. As this property directly influence drug release profile, so Vision Pharmaceutical production unit carefully monitor specific surface area of every individual batch of single or multi ingredient drug Pellets evaluation.

Disintegration Time:

Disintegration time very important characteristic for immediate release pellets. It can influence actual drug availability in vitro and peak plasma concentrations at various time intervals. Vision Pharmaceutical uses latest Disintegration Apparatus to measure disintegration time of every batch of drug Pellets.






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Vision Pharmaceutical bulk manufacturing facilities ensure market competitive price without slightest compromise on quality

Contact Number

+92 (51) 4493589



Email Address

drabidyaqoob@hotmail.com



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