All the tablets prepared were evaluated for content of active ingredient, hardness, friability, and disintegration time and dissolution rate. Excipients play a central role in the drug development process, in the formulation of stable dosage forms and in their administration. 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. Coprocessed excipient consists of two or more excipients combined in a way to attribute superior properties than simple physical admixture. Many factors play a significant role in the compression behavior. Directly compressible excipients are costly because these are prepared by spray drying, fluid bed drying, roller drying or cocrystallization. Coprocessing is the one of the most widely explored and commercially utilized method for the preparation of directly compressible adjuvant. Proprietary names should not be used for individual excipients. 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. This work proposes to study the compression behavior of the directly compressible excipients microcrystalline cellulose mcc. Aceclofenac tablets prepared using coprocessed excipients showed better hardness, disintegration time and in. Directly compressible tablet excipients dc grade solid. Coprocessed excipients have the ability to improve flow andor compressibility characteristics of an api which otherwise is difficult to be formulated into. Coprocessed excipients by virtue of combining properties of.
Pdf directly compressible adjuvants a pharmaceutical approach. Marg, govandi, mumbai, india received 16 november 2004, revised 28 january 2005, accepted 31 january 2005, published 16 april, 2005. Us4994276a directly compressible sustained release excipient. 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. It eases the compaction process by reducing wall friction during tablet ejection, improves flowability, bulk.
International journal of applied pharmaceutics innovare academic. These excipients are not only directly compressible themselves, but can also be mixed with a large proportion of drug. Comparison of major steps involved in the granulation methods. 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. Guidance appropiate gmp for pharmaceutical excipients. For the development of coprocessed excipient, release retarding polymers. Tablets of good quality fulfilling the official specifications with regard to drug content, hardness, friability. 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. The central role of excipients in drug formulation. Pdf comparative study of directly compressible excipients for fdt. However, the development of such combinations is a complex process because one excipient may interfere with the existing functionality of another excipient.
Article 59 1a 2 nd indent requires a full statement of the. Microcrystalline cellulose undergoes plastic deformation whereas dicalcium phosphate undergoes brittle fracture. 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. Experimental excipientsdirectly compressible diluent. Qualification of excipients for use in pharmaceuticals. Development and characterization of multifunctional directly compressible coprocessed excipient by spray drying method article in aaps pharmscitech 184 august 2016 with 30 reads. 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. 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. Atab in all the formulations excipients other than directly compressible vehicle are kept same. Development of directly compressible excipients from phoenix. Methods of preparing directly compressible excipients directly compressible adjuvant can be prepared by various methods. The second objective was to identify the predominant form of deformation for the two different directly compressible excipients. We commit to flexibility and agility open innovation. Directly compressible tablet excipients dc grade the direct compression procedure for tablets is becoming increasingly popular in the pharmaceutical industry, and offers significant advantages.
The outline and main features of the methods are depicted in table 2. Directly compressible adjuvant can be prepared by various methods. A novel directly compressible coprocessed excipient for. Development of directly compressible coprocessed excipients. The calcium sulphate used as a diluent in the capsule had been replaced by lactose and this. Methods of preparing directly compressible excipients. The present work emphasises on development of directly compressible. Introduction excipients are inert substances used as diluents or vehicles for a drug. Compression behavior evaluation of directly compressible.
Ipec defines excipient as substances, other than the. The international pharmaceutical excipients council ipec. Because of this relatively high demand for functional excipients, the us and europe will lead in this segment 4, 5. Currently, magnesium stearate is the most widely used lubricant. The purpose of the present research was to prepare and evaluate mannitol and cellulose based, directly compressible excipient using freezethawing technique. Phase 3 the negotiation process section 5 excipient supplieruser negotiation process. In practice, the diluents can be ranked in following order in terms of their. Excipient definition of excipient by merriamwebster. Gohel lallubhai motilal college of pharmacy, navarangpura, ahmedabad, india pranav d jogani usv limited, b. Development of novel multifunction directly compressible coprocessed excipient by melt granulation technique. The various features of the methods are given in table 2.
Excipient functionality has been expanded by direct compression process and the need to use highspeed equipment in tablet manufacturing. Polyethylene oxide, hydroxyl propyl methyl cellulose, coprocessing. As the volume decreases through the region of maximum pressure, the powder material. Directly compressible adjuvants the international pharmaceutical excipients council ipec defines excipient as substances, other than the api in finished dosage form, which have been. Directly compressible excipients can be prepared by various methods listed in table 1. Strategies for development of directly compressible coprocessed excipients used in tablet.
An overview of the different excipients useful for the. Seppic has several ongoing internal and external partnership for innovation skills. Examples of dcv lactose lactose derivatives starch cellulose derivatives sugar and sugar. Anhydrous theophylline 10% ww was used as a drug model, emdex andor maltrin m 510 89. Development and characterization of multifunctional. Formulation and evaluation of novel coprocessed excipients. Excipient definition is a usually inert substance such as gum arabic or starch that forms a vehicle as for a drug. 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.
Nomenclature the following applies to the names of all excipients on the labelling, package leaflet and the smpc. It is widely cultivated and may be seen adorning avenues, parks and estates in tropical cities throughout the. 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. The outline and main features of the methods are depicted in table 3 11, 17, 18. 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. 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. Coprocessing is the one of the most widely acceptable and commercially applicable method for the preparation of dce.
Screening of several excipients for direct compression of. A novel directly compressible dc coprocessed excipient with improved functionality and masking the undesirable properties of individual excipients was developed without any chemical modification by using simple laboratory technique. Development of novel multifunction directly compressible co. Dc calcium carbonate based pharmaceutical excipients. Pdf objective of this study was to formulate directly compressible fast dissolving tablets of cinnarizine with sufficient mechanical integrity. Excipients even though considered inert substance, have the tendency to react with drug components, other excipients, and also the packaging system. Review paper interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients. Chapter formulation development of parenteral products. Design and optimization of directly compressible matrix. Section 4 excipient user assessment, selection, and specification process. Compressional characterization of two dextrosebased. Type c is for faster disintegration needs, while type m has better flow properties and improves the.
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. Interactions and incompatibilities of pharmaceutical. Production of directly compressible excipients with. Directly compressible sustained release excipient download pdf. Coprocessing is the one of the most widely explored and commercially utilized method for the preparation of directly compressible adjuvants.
The physical properties of pharmaceutical powdersgranules are very important in the development of oral solid dosage forms. Formulation result of dta interaction shelf life inference f 1. 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. Fmelt directly compressible excipient system for fast. Pdf a novel directly compressible coprocessed excipient. In order to enhance flow, lubricating excipients are employed. Societys modern college of pharmacy for ladies, borhadewadi, atpost moshi, talhaweli, dist pune, maharashtra 412105, india. 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. Preparation of directly compressible coprocessed excipients in roller compaction method the fine powder force between two counter rotating rolls. Methods of preparing directly compressible excipients 3 dce can be prepared by various methods. The international pharmaceutical excipients council. In the direct compression process, the components of a dry powder are pressed together directly without pregranulation to form a tablet. A corn starchalactose monohydrate compound as a directly. Results indicated that the new excipient has excellent flow properties and demonstrates enhanced compressibility.
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