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Multiparticulate Drug Delivery Systems for Controlled Release

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Multiparticulate Drug Delivery Systems for Controlled Release Adisa et al Tropical Journal of Pharmaceutical Research, September 2008; 7 (3): 1067-1075 © Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, 300001 Nigeria. All rights reserved . Available online at http://www.tjpr.org Review Article Multiparticulate Drug Delivery Systems for Controlled Release NS Dey*, S Majumdar and MEB Rao Department of Pharmaceutics, Roland Institute of Pharmaceutical Sciences, Khodasinghi, Berhampur, Orissa760010, India Abstract Pharmaceutical invention and research are increasingly focusing on delivery systems which enhance desirable therapeutic objectives while minimising side effects. Recent trends indicate that multiparticulate drug delivery systems are especially suitable for achieving controlled or delayed release oral formulations with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time. The release of drug from microparticles depends on a variety of factors including the carrier used to form the multiparticles and the amount of drug contained in them. Consequently, multiparticulate drug delivery systems provide tremendous opportunities for designing new controlled and delayed release oral formulations, thus extending the frontier of future pharmaceutical development. Keywords: Dose dumping, Microparticles, Multiparticulate delivery system, Delayed release *Corresponding author: Email: [email protected] Phone no: +91-09861352986 1067 Trop J Pharm Res, September 2008; 7 (3) Dey et al INTRODUCTION Drug safety may also be increased by using Multi-particulate drug delivery systems are multiparticulate dosage forms, particularly for mainly oral dosage forms consisting of a modified release systems. For example, if the multiplicity of small discrete units, each film coat of a single-unit (monolithic) enteric exhibiting some desired characteristics. In coated tablet is damaged, the complete dose these systems, the dosage of the drug will be released into the stomach where it may substances is divided on a plurality of subunit, cause pain or ulceration or reduced efficacy, typically consisting of thousands of spherical depending on the reason for choosing the particles with diameter of 0.05-2.00mm 1. Thus protection of the enteric coating. Equally, if multiparticulate dosage forms are there is damage to the film coating of a pharmaceutical formulations in which the monolithic tablet with a sustained release active substance is present as a number of formulation, this can lead to “dose dumping” small independent subunits. To deliver the and result in dramatic side effects. By recommended total dose, these subunits are contrast, in multiparticulate formulation, the filled into a sachet and encapsulated or release characteristics are incorporated into compressed into a tablet 4. Multiparticulates every single subunit and any damage only are discrete particles that make up a multiple- affects the release behavior of the subunit unit system. They provide many advantages involved, which represents a small part of the over single-unit systems because of their total dose, reducing the likelihood of safety small size. Multiparticulates are less problems 4. dependent on gastric empty ting, resulting in less inter and intra-subject variability in SOME APPROACHES TO gastrointestinal transit time. They are also MULTIPARTICULATE FORMULATION better distributed and less likely to cause local A multiparticulate floating–pulsatile drug irritation 2. Recently much emphasis is being delivery system was developed using porous laid on the development of multiparticulate calcium silicate [RE(R)] and sodium alginate, dosage forms in preference to single unit for time and site specific drug release of systems because of their potential benefits meloxicam 5. such as increased bioavailability, reduced risk An oral controlled onset extended release of systemic toxicity, reduced risk of local dosage form intended to approximate the irritation and predictable gastric emptying 3. chronobiology of rheumatoid arthritis was There are many reasons for formulating a proposed for site specific release to the colon. drug as a multiparticulate system for example, The multiparticulate system consisting of drug to facilitate disintegration in the stomach, or to loaded cellulose acetate cores encapsulated provide a convenient, fast disintegrating tablet within Eudragit S-100 microcapsules was that dissolves in water before swallowing designed for chronotherapeutic delivery of which can aid compliance in older patients ketoprofen 6. The site-specific delivery of drugs and children. Multiparticulate systems show to the colon has implications in a number of better reproducible pharmacokinetic behavior therapeutic areas, which include topical than conventional (monolithic) formulations. treatment of colonic disorders such as Crohn’s After disintegration which occurs within a few disease, ulcerative colitis, constipation, minutes often even within seconds, the colorectal cancer, spastic colon and irritable individual subunit particles pass rapidly bowel syndrome 7. through the GI tract. If these subunits have Multiparticulates approaches tried for colonic diameters of less than 2mm, they are able to delivery includes formulations in the form of leave the stomach continuously, even if the pellets, granules, microparticles and pylorus is closed. These results in lower intra nanoparticles. Because of their smaller and inter individual variability in plasma levels particle size compared to single unit dosage and bioavailability. forms these systems are capable of passing through the GI tract easily, leading to low inter 1068 Trop J Pharm Res September 2008; 7 (3) Dey et al and -intra subject variability. Moreover, release system based on coated pellets multiparticulate systems are to be more containing an osmotic active ingredient has uniformly dispersed in the GI tract and also been prepared. The coating consisted of a ensure more uniform drug absorption 3. A semi permeable membrane of cellulose multiparticulate system of chitosan hydrogel acetate. Following ingestion water penetrates beads has been investigated for colon-specific into the core and forms a saturated solution of delivery of macromolecules using fluorescein the soluble components. The osmotic is othiocyanate-labeled bovine serum albumin pressure gradient induces a water influx as a model protein 8. resulting in a rapid expansion of the Multiparticulates may be prepared by several membrane leading to the formation of pores. methods. Different methods require different The osmotic ingredient and the drug are processing conditions and produce released through these pores according to multiparticulates of distinct qualities. Some of zero order kinetics. In comparison with the these methods may be broadly classified as sodium chloride free formulation the inclusion pelletization, granulation, spray drying, and of the osmotically active ingredient results in a spray congealing. Drug particles may be completely different dissolution behavior. Lag entrapped within the multiparticulates or time and dissolution rate were dependent on layered around them. Subsequently, these the coating level and the osmotic properties of multiparticulates may be modified in many the dissolution medium 10 . ways to achieve the desired drug release profile. MECHANISM OF DRUG RELEASE FROM One approach to the modification of drug MULTI-PARTICULATES release profile in multiparticulates is to coat The mechanism of drug release from them. Reasons for the application of coating multiparticulates can be occur in the following onto maltiparticulates are to obtain functional ways: coats, provide chemical stability, improve Diffusion physical characteristics and enhance patient acceptance. Coats are formed from various On contact with aqueous fluids in the polymeric coating materials broadly classified gastrointestinal tract (GIT), water diffuses into as aqueous polymer dispersions, polymer the interior of the particle. Drug dissolution solutions, molten polymers and dry powders. occurs and the drug solutions diffuse across Depending on the type of coating material the release coat to the exterior. used, functions such as sustained release Erosion (SR), targeted release, delayed release, and pulsatile release can be achieved. Some coatings can be designed to erode The most common method used for the gradually with time, thereby releasing the drug application of coating onto multiparticulates is contained within the particle. air suspension coating. Other methods include compression coating, solvent evaporation, Osmosis coacervation, and interfacial complexation. It In allowing water to enter under the right is also possible to form coated circumstances, an osmotic pressure can be multiparticulates by spray drying and spray built up within the interior of the particle. The 2 congealing . A multiparticulate composition drug is forced out of the particle into the may allow controlled release of the drug over exterior through the coating 1. a wide range of release rates, and permit the release rate to be set at a predetermined rate, DESIGN OF MULTIPARTICULATE DRUG such a formulation may be formed using a DELIVERY SYSTEMS melt-congeal process which maintains the The purpose of designing multiparticulate crystallinity of the drug during the melt- dosage form is to develop a reliable 9 congeal process . A multiparticulate delayed formulation that has all the advantages of a 1069 Trop J Pharm Res September
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