Excipients play a central role in the drug development process, in the formulation of stable dosage forms and in their administration. Coprocessing is the one of the most widely acceptable and commercially applicable method for the preparation of dce. Delonix regia is a flamboyant tree native to madagascar, its seeds have traveled the world and the species is now common through the tropical cities 15. Interactions and incompatibilities of pharmaceutical. Experimental excipientsdirectly compressible diluent. Aceclofenac tablets prepared using coprocessed excipients showed better hardness, disintegration time and in. Pdf comparative study of directly compressible excipients for fdt.
Marg, govandi, mumbai, india received 16 november 2004, revised 28 january 2005, accepted 31 january 2005, published 16 april, 2005. The purpose of the present research was to prepare and evaluate mannitol and cellulose based, directly compressible excipient using freezethawing technique. Directly compressible tablet excipients dc grade the direct compression procedure for tablets is becoming increasingly popular in the pharmaceutical industry, and offers significant advantages. Design and optimization of directly compressible matrix. Design and optimization of directly compressible matrix tablets of recrystallized metformin hcl using full factorial design adimoolam senthil, prasanthi sri, ahmad bin mahmud and natesan gopal abstractmetformin hcl is an oral antihyperglycemic agent used in the treatment of noninsulin dependent diabetes mellitus. Development and characterization of multifunctional directly compressible coprocessed excipient by spray drying method article in aaps pharmscitech 184 august 2016 with 30 reads. Excipients may also contain various impurities which may result in decomposition of the active pharmaceutical ingredients in the formulation thus altering the shelf life of the formulation. Review paper interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients. Demand for functional excipients is expected to grow at a compound annual rate of 8 to 10 percent for the period from 2016 to 2020, compared to 3 to 4 percent for traditional excipients. Development of novel multifunction directly compressible co. Excipient definition of excipient by merriamwebster.
These excipients are not only directly compressible themselves, but can also be mixed with a large proportion of drug. The calcium sulphate used as a diluent in the capsule had been replaced by lactose and this. Coprocessed excipients by virtue of combining properties of. Atab in all the formulations excipients other than directly compressible vehicle are kept same. Coprocessing is based on the novel concept of two or more excipients interacting at the sub particle level, the objective of which is to provide a synergy of functionality improvements as well as masking the undesirable properties of individual excipients7. Directly compressible excipients are costly because these are prepared by spray drying, fluid bed drying, roller drying or cocrystallization. Screening of several excipients for direct compression of. Directly compressible excipients can be prepared by various methods listed in table 1.
Seppic has several ongoing internal and external partnership for innovation skills. Excipient definition is a usually inert substance such as gum arabic or starch that forms a vehicle as for a drug. Chapter formulation development of parenteral products. The central role of excipients in drug formulation. Coprocessed excipient consists of two or more excipients combined in a way to attribute superior properties than simple physical admixture.
The international pharmaceutical excipients council ipec. Qualification of excipients for use in pharmaceuticals. Oswaldo castaneda hernandez, efren hernandez baltazar, enrique amador gonzalez, luz maria melgoza contreras. Appropriate gmp for pharmaceutical excipients eca course 15 16 november 2016 prague, czech republic. Directly compressible tablet excipients dc grade solid. Strategies for development of directly compressible coprocessed excipients used in tablet. Ipec defines excipient as substances, other than the. Development and characterization of multifunctional.
Polyethylene oxide, hydroxyl propyl methyl cellulose, coprocessing. Production of directly compressible excipients with. In the pharmaceutical industry it is a catchall term which includes various subgroups comprising diluents or fillers 19, binders or adhesives, disintegrants, lubricants, glidant, flavors, colors and sweeteners. The international pharmaceutical excipients council. Development of directly compressible coprocessed excipients. Methods of preparing directly compressible excipients 3 dce can be prepared by various methods.
In the direct compression process, the components of a dry powder are pressed together directly without pregranulation to form a tablet. Although the principles governing direct compression have been well known for many years, the technique has only recently become more established as a result of the introduction of excipients specifically designed for direct compression 5. Proprietary names should not be used for individual excipients. Compressional characterization of two dextrosebased. The second objective was to identify the predominant form of deformation for the two different directly compressible excipients. This work proposes to study the compression behavior of the directly compressible excipients microcrystalline cellulose mcc. Pdf directly compressible adjuvants a pharmaceutical approach. Guidance appropiate gmp for pharmaceutical excipients. The tabletting properties of a new coprocessed excipient for direct compression were compared with a physical mixture of its components separately and with drugs and the individual constituents. All the tablets prepared were evaluated for content of active ingredient, hardness, friability, and disintegration time and dissolution rate. Dc calcium carbonate based pharmaceutical excipients. Other direct compressible excipients such as microcrystalline cellulose the first effective dry filler and binder, starch 1500 a compressible starch which maintains its disintegrant properties, emcompress a freeflowing dicalcium phosphate and a number of direct compression sugars also appeared in the pharmaceutical market. Pdf objective of this study was to formulate directly compressible fast dissolving tablets of cinnarizine with sufficient mechanical integrity.
Formulation result of dta interaction shelf life inference f 1. It eases the compaction process by reducing wall friction during tablet ejection, improves flowability, bulk. The aim of this paper was, in a first stage, to carry out an evaluation of the flow properties angle of repose, flow time, compaction capacity, compressibility index, carr index and hausner ratio of technological or primary excipients of tablets microcrystalline. Excipients even though considered inert substance, have the tendency to react with drug components, other excipients, and also the packaging system. The outline and main features of the methods are depicted in table 3 11, 17, 18. Development of directly compressible excipients from phoenix. Comparison of major steps involved in the granulation methods. Results indicated that the new excipient has excellent flow properties and demonstrates enhanced compressibility. Examples of dcv lactose lactose derivatives starch cellulose derivatives sugar and sugar. International journal of applied pharmaceutics innovare academic. Type c is for faster disintegration needs, while type m has better flow properties and improves the. Us4994276a directly compressible sustained release excipient. Societys modern college of pharmacy for ladies, borhadewadi, atpost moshi, talhaweli, dist pune, maharashtra 412105, india.
The handbook of pharmaceutical excipients contains monographs for 340 excipients, with each monograph including a safety section that presents adverse reactions that have been reported. The present work emphasises on development of directly compressible. Introduction excipients are inert substances used as diluents or vehicles for a drug. A bad choice of excipient can even lead to severe intoxications, as experienced by epileptic patients in australia in the late 1960s who were taking phenytoin capsules 2. Microcrystalline cellulose undergoes plastic deformation whereas dicalcium phosphate undergoes brittle fracture. Section 4 excipient user assessment, selection, and specification process. Coprocessed excipients have the ability to improve flow andor compressibility characteristics of an api which otherwise is difficult to be formulated into. In practice, the diluents can be ranked in following order in terms of their. Coprocessing is the one of the most widely explored and commercially utilized method for the preparation of directly compressible adjuvant. Nomenclature the following applies to the names of all excipients on the labelling, package leaflet and the smpc. Anhydrous theophylline 10% ww was used as a drug model, emdex andor maltrin m 510 89. Article 59 1a 2 nd indent requires a full statement of the. Coprocessing is the one of the most widely explored and commercially utilized method for the preparation of directly compressible adjuvants.
Compression behavior evaluation of directly compressible. Many factors play a significant role in the compression behavior, such as the particle size and particle size distribute, flowability, particle density, porosity and so on, thus making it necessary to understand the dominant contribution of each factor. Fmelt directly compressible excipient system for fast. Formulation and evaluation of novel coprocessed excipients. Directly compressible adjuvant can be prepared by various methods. Methods of preparing directly compressible excipients. An overview of the different excipients useful for the. Many factors play a significant role in the compression behavior. Excipient functionality has been expanded by direct compression process and the need to use highspeed equipment in tablet manufacturing. Development of novel multifunction directly compressible coprocessed excipient by melt granulation technique. Directly compressible adjuvants the international pharmaceutical excipients council ipec defines excipient as substances, other than the api in finished dosage form, which have been. The coprocessing is the most widely explored method for the preparation of directly compressible adjuvants because it is cost effective and can be prepared in. Pdf a novel directly compressible coprocessed excipient. Gohel lallubhai motilal college of pharmacy, navarangpura, ahmedabad, india pranav d jogani usv limited, b.
Preparation of directly compressible coprocessed excipients in roller compaction method the fine powder force between two counter rotating rolls. The physical properties of pharmaceutical powdersgranules are very important in the development of oral solid dosage forms. Directly compressible sustained release excipient download pdf. The various features of the methods are given in table 2. It is widely cultivated and may be seen adorning avenues, parks and estates in tropical cities throughout the. For the development of coprocessed excipient, release retarding polymers. A novel directly compressible coprocessed excipient for. Tablets of good quality fulfilling the official specifications with regard to drug content, hardness, friability. Because of this relatively high demand for functional excipients, the us and europe will lead in this segment 4, 5.
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