An Overview on Sustained Release Enteric Coated
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Roobi et al Journal of Drug Delivery & Therapeutics; 2014, 4(4), 130-136 130 Available online on 15.07.2014 at http://jddtonline.info Journal of Drug Delivery and Therapeutics Open access to Pharmaceutical and Medical research © 2014, publisher and licensee JDDT, This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited REVIEW ARTICLE AN OVERVIEW ON SUSTAINED RELEASE ENTERIC COATED TABLET OF PANTOPRAZOLE Singh Roobi *, Sharma Pramod Kumar, Dhakad Prashant Kumar Department of Pharmacy, School of Medical and Allied Sciences, Galgotias University, Plot No.2, Sector-17A, Yamuna Expressway, Greater Noida, Uttar Pradesh, India ABSTRACT Enset (Ensete Ventricosum, Family Musaceae) is a plant indigenous to Ethiopia, it is often called „false banana” for its close resemblance to banana plant. The plant is the most important staple food for millions of people in the south and southwestern parts of Ethiopia. Enset plant contains starch as its major contents. The starch has been investigated for its physico-chemical properties including granule size, X-ray diffraction pattern, amylose content, gelatinization behavior, stability and various rhelogical properties of the gel. Based on its physico-chemical properties the starch was evaluated for various pharmaceutical applications such as in tablet binder and disintegrant. Several modifications were also attempted on the native enset starch so as to improve and modulate its physiochemical properties. Hence, this review aims to summarize the knowledge on the properties of enset starch and its pharmaceutical applications. Key words: Enset Starch, Physico-Chemical Properties, Pharmaceutical Application ABSTRACT Pantoprazole drug is utilized for treatment of gastric and the digestive system where it is absorbed. Enteric coating duodenum ulcer, utilized as proton pump inhibitor, belongs to refers to theminuscule intestine, therefore enteric group of Benzimidazole. Pantoprazole drug undergoes through coatings reduces release of medication before it reaches acidic medium of the stomach, can be coated with enteric the minuscule intestine. Maximum enteric coatings coating polymer after that they will safely distribute the drug in perform by presenting a surface that is stable at the the musculin intestine, for the degradation. Pantoprazole has highly acidic pH found in the stomach, but rapidly been prepared by direct compression method utilizing variant 2 excipient on different concentration like crosscarmellose breaks down at a low acidic mediapH . Pantoprazole sodium as disintegrating agent, dicalcium phosphate as diluents drugs with short half-lives are ideal dosage form for and mannitol. Direct compression is economic since it requires sustained drug distribution. Pantoprazole sodium is a fewer unit operations, compare to wet granulation method. This white to off-white crystalline powder, racemic and has direct compression method require less equipment, need low weakly basic and acidic properties. It is liberatingly power consumption, less space, short duration, leading to low soluble in dihydrogen monoxide, very slightly soluble in cost of tablets dosage form. The prepared tablets has been phosphate buffer at pH 7.4, and virtually insoluble in n- evaluated by different evaluation parameter like hardness, hexane. The stability of the compound in aqueous surface morphology, weight variation, friability, percentage yield, and it was found that the results comply with official solution is pH-dependent. Different drugs have been standards. The in-vitro release has been evaluated utilizing pH marketed as sustained release tablets according to their 1.2 acidic buffer and pH 6.8 phosphate buffer. The in-vitro cost efficacy and excellent patient compliance. Now release study showed that the prepared and evaluated present study, we made an endeavor to distribute pantoprazole tablets are capable to sustain release drug in the pantoprazole in a sustained manner utilizing enteric intestine. coated release tablets and studied their efficacy for 3 Keyword: - Pantoprazole sodium, enteric coated, ulcer,in-vitro treating ulcer . Several types of studies are published release. regarding pantoprazole pharmacokinetics, veryless studies of them have fixated on the proof of INTRODUCTION bioequivalence between two formulations. For such Tablets are utilized as solid dosage forms containing types of drugs, enteric coating mixed to the formulation medicinal substances or excipient with or without inclines to avoid the stomach's acidic exposure, diluents. Solid dosage forms are the most widely used distributing them instead to a fundamental pH form of medication both by pharmaceutical company as environment (intestines pH 5.5) where they do not well as medicos and patients. They provide safe and degrade, and give their desired therapeutic effect. facile ways of active pharmaceutical ingredients (API) *Corresponding Author administration with great physicochemical stability in Roobi Singh, M.Pharm Scholar comparison to some other different dosage forms, and Department of Pharmacy, School of Medical & Allied Sciences, also gives designates of precise dosing 1. An enteric Galgotias University, Greater Noida, India coating is an opportune barrier applied to oral medication Email: [email protected] (solid dosage form) that controls the targeted location in Contact no- 07827642549 © 2011-14, JDDT. All Rights Reserved ISSN: 2250-1177 CODEN (USA): JDDTAO Roobi et al Journal of Drug Delivery & Therapeutics; 2014, 4(4), 130-136 131 The aim of this study is to prepare and formulae of Susceptible/permeable to intestinal fluid enteric coated pantoprazole tablet. Proton pump Compatibility with most coating solution inhibitors (PPIs) reduced gastric acid secretion by components and the drug substrate concrete inhibition of the H+/K+- ATPase in the gastric Formation of continuous film parietal cell. This process follows with absorption of the Nontoxic, cheap and ease of application Proton pump inhibitors in the parietal cell. Proton pump Ability to be readily printed inhibitors are related to bases, so protonation takes place 12 in the acidic region of the secretory canaliculus of the Advantage of enteric coated tablet parietal cell. The main aim of an oral tablet is to provide 1. Enteric coating is employed for a number of a certain and agreeable amount of drug to the human therapeutic, safety, and medical reasons. Some drugs body through GI system. Studies on bioavailability of are procure when directly exposed to the mucosa, drugs from a given study showed that in many situations gastric, including aspirin and vigorous electrolytes tablets with same drug and drug amount did not give the such as NH4Cl. same therapeutic effect. Formulation excipient in the 2. Enteric coating is one method of reducing or tablet, physical which is responsible for variation in the eliminating vexation from such drugs. There are quantified dissolution profile and therapeutic 4 other drug that if abandonment in the stomach may replication .Drugs such as pantoprazole which have an create nausea and vomiting. irritant effect on the stomach and must be absorbed in the 3. The low pH of the stomach destroy other drug, and gastrointestinal tract and because it is unstable under hence enteric coating may be the desire to abandon acidic conditions, enteric coated distribution systems are the drug undiluted and in the highest concentration required. Similarly, certain groups of Azoles are acid- possible within the intestine. unstable. For such types of drugs, enteric coating 4. In case of repeat action and other controlled release integrated to the formulation inclines to eschew the dosage form, the influence of altering the profile of stomach's acidic exposure, distributing them instead to a the drug on total drug bioavailability, distribution, fundamental pH environment (intestines pH 5.5 and and pharmacokinetics must be investigated. above)where they do not degrade, and give their desired action2.The different release characteristics of the enteric Disadvantages of tablet coating polymers have profound impact upon the 5, 6 1. Limitations of sugar coating such as relatively high pharmacokinetic parameters of the drug . An Ideal cost, long coating time and high bulk had led to the enteric polymer should possess a hydrophilic and use of other coating materials. hydrophobic monomeric unit. Methacrylic acid and 2. However the process of coating is tedious and time- methyl methacrylate could make an ideal hydrophilic and consuming and it requires the expertise of highly hydrophobic unit respectively. Such compositions of skilled technician. polymer are essentially insoluble in gastric fluids and may avail conveyance of drugs across the proximal Coating equipment alimentary tract without degradation 7. Pantoprazole is A modern tablet coating system combines several highly selective to acid secretive gastric parietal cells and component – its action is irrespective of the type of stimuli. Despite its several therapeutic benefits including maximal efficacy- A coating pan safety ratio 8. A spraying system Ideal properties of enteric coating material9, 10, 11. An air handling unit A dust collector Resistance to gastric fluids Different types of polymer used in enteric coating tablets13– Polymers Dissolution pH Shellac (esters of aleurtic acid) 7.0 Cellulose acetate phthalate (CAP) 6.2 Poly(methacrylic acid-co-methyl methacrylate) 5.5-7.0 Cellulose acetate trimellitate (CAT) 5.0 Poly(vinyl