TAJ Sevelamer tablets as specialty Phosphorous (hyperphosphatemia) drug with patients receiving by Taj Pharma

Sevelamer tablets as specialty Phosphorous (hyperphosphatemia) drug with patients receiving Blood purification (haemodialysis) or peritoneal dialysis.

Taj Pharmaceuticals Ltd India | Taj Pharma | Taj Pharmaceuticals Mumbai, Company Overview of Taj Pharmaceuticals Limited |Taj Pharmaceuticals Limited Taj Pharmaceutical an Industrial conglomerate, having diversified interest in Pharmaceuticals and healthcare, Chemicals, API and Agro commodities mainly offers unique opportunities for all its associates to grow in capacity as one of a significant part in curing lives worldwide and building a disease-free nation. Taj Pharma is having more than 600+ brands in different divisions and multiple subsidiaries to meet up most of the requirements of buyers in our industry along with a very efficient staff management capacity.

Nagaraju. K (M.Pharm) Taj Pharmaceuticals an Industrial conglomerate, having diversified interest in Pharmaceuticals and healthcare, Chemicals, API and Agro Agro commodities mainly offers unique opportunities for all its associates to grow in capacity as one of a significant part in curing lives worldwide and building a disease-free nation.

Contents: 1. Drug Introduction 2. Drug Delivery 3. Mechanism of action 3. Sevelamer forms/Strengths/Finished Product Table 4.Sevelamer finished product market a) Domestic b) Export 5.Therapeutic indication/Pharmacokinetics 6.Complications Related to Sevelamer API and finished product manufacturing 7)Alternative Drugs Available (Lower version / advanced versions) 8) Sevelamer and role of Taj Pharma as Generics Manufacturer Conclusion and future scope of research and advancement Taj Pharmaceuticals Ltd India | Taj Pharma | Taj Pharmaceuticals Mumbai, Company Overview of Taj Pharmaceuticals Limited |Taj Pharmaceuticals Limited Taj Pharmaceutical an Industrial conglomerate, having diversified interest in Pharmaceuticals and healthcare, Chemicals, API and Agro commodities mainly offers unique opportunities for all its associates to grow in capacity as one of a significant part in curing lives worldwide and building a disease-free nation. Taj Pharma is having more than 600+ brands in different divisions and multiple subsidiaries to meet up most of the requirements of buyers in our industry along with a very efficient staff management capacity.

Drug introduction Kidneys play an important role in body Phosphate balance, Excess Phosphate is removed by kidney.  Controlling Phosphate balance is important in people with advance CKD (Chronic Kidney Disease).  In disease condition Like CKD kidneys were unable to remove the excess Phosphate from serum.  As, a result there will be increased Cardiovascular Morbidity, Rigidity.  Sevelamer is available in 2 forms Sevelamer Hydrochloride and Sevelamer Carbonate.  Sevelamer carbonate is used mostly because of does not increase risk of metabolic acidosis. 

Drug Delivery Drug is a Novel Calcium free Iron Phosphate Binder.  Tablets should be Crushed by teeth because of it should be Disintegrate immediately.  Drug works in the stomach only, “Drug will not enter into Blood stream”.  Chemical Structure: 

Mechanism of action A Novel drug calcium free Iron Phosphate Binder.  Amine group Present in the sevelamer is protonated which interacts with negatively charged Phosphate ion.  Interaction of sevelamer and Phosphate ions by ionic binding & Hydrogen bonding.  Each tablet of sevelamer can bound to 130mg of Phosphate ions.  3 tablets in a day can bound around 400mg of Phosphate ions in GI tract.  Ultimately, the Phosphate ions eliminated through alimentary canal. 

Product Details  

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Brand name: Sevelamer carbonate tablets 800 mg Label claim: Each film coated tablet contains: Sevelamer carbonate ……….800 mg Excipients …………………..Q.s Company name: Taj Pharmaceuticals Limited. MRP: xx.xx Location: Ahmedabad, Gujarat. Generic name: Sevelamer carbonate Oval, white to off-white film-coated tablets. The tablets are debossed with ‘TAJ’ on one side. Shelf life: 3 years. Nature & contents of Container:10 Tablets Alu-Alu blister.

Market Packs

Product View

Products available in Market Sr.No

Name of the product

Quantity

Brand name

Manufacturer

Sevelamer carbonate

800 mg

SEVCAR 800

EMCURE

Sevelamer carbonate

400 mg

SEVCAR 400

EMCURE

Sevelamer Hydrochloride Sevelamer Hydrochloride

800 mg

FOSROS 800

EMCURE

400 mg

BIOSEV 400

BIOCON

Sevelamer finished forms Taj Pharma Sr.No

Name of the Product

Quantity

Brand name

Manufacturer

Sevelamer Carbonate

400mg, 800 mg

Sevelamer carbonate tablets â&#x20AC;&#x201C; Generic; FosControl, Renaval

Taj Pharma

Sevelamer Hydrochloride

400mg, 800 mg

Sevelamer hydrochloride tablets â&#x20AC;&#x201C; Generic; Fos-Control, Renaval

Taj Pharma

Therapeutic indication   

Dose range: 2.4g to 4.8g Taj sevelamer 800mg film coated tablets should not be used age under 18. Sevelamer is contraindicated in conditions like: a) Dysphagia b) Swallowing disorders c) Active inflammatory bowel disease d) Major gastrointestinal tract surgery e) Hypophosphatemia

Alternative Drugs Calcium carbonate: Increased risk of hypercalcemia and vascular tissue calcification, GI side effects. Inexpensive, readily available.  Calcium acetate: Potentially more effective than calcium carbonate, Increased risk of hypercalcemia, vascular tissue calcification & GI side effects.  Lanthanum carbonate: Use caution Because of accumulation Due to GI absorption more evidence need concerning long-term Consequences. 

Conclusion and Future Prospects  Sevelamer

carbonate was efficacious in controlling serum Phosphorus & well-tolerated in Patients with CKD.  A powder Oral suspension may also provide more suitable formulation than tablet, Taj Pharma working towards it.  Sevelamer carbonate significantly lowers serum Phosphorus levels in children with CKD and there is no Serious effects observed.  Sevelamer carbonate, bound most phosphate in the first hour and reached maximum binding capacity in less than 6 h. Taj Pharmaceuticals Ltd India | Taj Pharma | Taj Pharmaceuticals Mumbai, Company Overview of Taj Pharmaceuticals Limited |Taj Pharmaceuticals Limited Taj Pharmaceutical an Industrial conglomerate, having diversified interest in Pharmaceuticals and healthcare, Chemicals, API and Agro commodities mainly offers unique opportunities for all its associates to grow in capacity as one of a significant part in curing lives worldwide and building a disease-free nation. Taj Pharma is having more than 600+ brands in different divisions and multiple subsidiaries to meet up most of the requirements of buyers in our industry along with a very efficient staff management capacity.

References 1) Ketteler, Markus, et al. "Efficacy and tolerability of sevelamer carbonate in hyperphosphatemic patients who have chronic kidney disease and are not on dialysis." Clinical Journal of the American Society of Nephrology 3.4 (2008): 11251130. 2) Fan, Stanley, et al. "A randomized, crossover design study of sevelamer carbonate powder and sevelamer hydrochloride tablets in chronic kidney disease patients on haemodialysis." Nephrology Dialysis Transplantation 24.12 (2009): 3794-3799. 3) Fathallah-Shaykh, Sahar, et al. "Efficacy and safety of sevelamer carbonate in hyperphosphatemic pediatric patients with chronic kidney disease." Pediatric Nephrology 33.2 (2018): 325-333. 4) Schumacher, Stefan P., et al. "Influence of pH and phosphate concentration on the phosphate binding capacity of five contemporary binders. An in vitro study." Nephrology 24.2 (2019): 221-226.