Introduction direct compression is the process of tabletting of a blend of ingredients, the compression mix, without a preliminary granulation or aggregation process. Characterisation of a novel, multifunctional, coprocessed. Wo20175405a1 coprocessed excipient, obtained by spray. By co processing two excipients, formulators can produce an excipient with superior properties as compared to the individual ingredients. Large differences were found between co processed excipients, with avicel hfe102 showing the greatest proportion of insoluble material 87. Coprocessed excipients offer the option of using a single excipient with multiple functional properties, thereby reducing the number of excipients in inventory.
The international pharmaceutical excipients council. Levis evaluated co processed microcrystalline cellulose sodium lauryl sulphate prepared by an ultrasonic homogenization process followed by spray drying. The formulations with 55% co processed excipients involving 3% 0. A novel directly compressible coprocessed excipient for. Particulate pharmaceutical tablet excipient compositions comprising coprocessed microcrystalline cellulose and particulate usp calcium carbonate having a particle size distribution of 7 to 22. Coprocessed excipients for orally disintegrating dosage form. Coprocessed excipients have functionalities that are not achievable through sample blending. The utility of the co processed excipients can easily be demonstrated by formulating the tablets.
Coprocessed excipients could provide improved organoleptic pro. For the development of coprocessed excipient, release retarding polymers such as polyethylene oxide polyox wsr 301 and hydroxyl propyl. Ipec defines excipient as substances, other than the. The future of coprocessed excipients overview definition of coprocessed excipients regulatory aspects of coprocessing technological benefits of coprocessing why coprocessed excipients are the future pdf created with pdffactory pro trial version. Coprocessed excipient workshop drs revisions bac rcm bac v2. Coprocessing is defined as the combination of two or more excipients by a physical process.
Pdf multifunctional coprocessed excipients for improved tabletting. Most of the coprocessed excipients however had less than 30% insoluble components, with the only exception of avicel hfe102. In some cases, they are able to hold up to 50% of the. Coprocessed excipients market size, share, opportunities. The different batches of the tablets containing drugexcipient x ratios of 1. Co processed excipients are expected to play a key role in the production of new chemical entities nces, according to bcc research. In this study, acacia and calcium carbonate caco3 were used to prepare a co processing excipient suitable for the preparation of atorvastatin calcium tablets. The following study aimed to characterise a range of co processed excipients that may prove suitable for dispersible tablet formulations prepared by direct compression. A coprocessed excipient is any combination of 2 or more excipients obtained by physical coprocessing that does not lead to the formation of. As developing new excipients can be timeconsuming and expensive from a safety perspective, manufacturers see co processing of already approved excipients as an attractive alternative. The aim of this study was to identify the most suitable coprocessed excipient to use within directly compressible dispersible tablet formulations. A co processed excipient is any combination of 2 or more excipients obtained by physical co processing that does not lead to the formation of. Co processed excipients are formulated on the base of. Coprocessed excipients, coprocessing, direct compression, directly compressible adjuvants, high functionality excipients, tablet.
The compression mix contains the active pharmaceutical ingredient blended with one or more excipients. Today, a large number of co processed excipients are available in pharmaceutical market, for example, prosolv, starlac, advantose fs95, avicel ce15, ludipress, etc. Optimization of direct compressions coprocessed excpient. As the chemical change is absent, they are considered to retain the gras generally regarded as safe status. Excipients as like other active pharmaceutical ingredients need to be stabilized and standardized. Coprocessed excipients are a combination of two or more excipients designed to physical mixing and without significant chemical change. Co processing of excipients the actual process of developing a co processed excipient involves the following steps. Co processed excipients with combination of two or more existing excipients at subparticle level interaction will provide an attractive tool for developing high functionality excipients. Jul, 2015 co processed excipients combination of two or more compendial or non compendial excipients to physically modify their properties. According to verified market research, the global coprocessed excipients market is growing at a faster pace with substantial growth rates over the last few years and is estimated that the market will grow significantly in the forecasted period i. Coprocessing of excipients in the pharmaceutical industry can be dated back to the late 1980s with the introduction of co processed microcrystalline cellulose and calcium carbonate20, followed by cellactose meggle corp. The ipecpqg good manufacturing practices audit guideline. Coprocessing 4 coprocessing is a process in which 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. Coprocessed excipients workshop 14pm april 29th 20 brian carlin dave schoneker chris moreton coprocessed excipients workshop apr 29th 20 1 abstract greater use of coprocessed excipients is a logical outcome of quality by design, whereby tailored combinations of physical properties are provided, beyond what can be achieved by.
Although coprocessed excipients are more costly, the overall product cost decreases because of improved functionality and fewer test requirements compared with. The co processing is the most widely explored method for the preparation of directly compressible adjuvants because it is cost effective and can be prepared inhouse based on the functi onality required. Coprocessing is the use of waste as raw material, or as a source of energy, or both to replace natural mineral resources material recycling and fossil fuels such as coal, petroleum and gas energy recovery in industrial processes, mainly in energy intensive industries eii such as cement, lime, steel, glass, and power generation. Now, more than 20 years after one of the first co processed excipients was patented, several newer co processed excipients are being commercialized.
Coprocessed excipients definition a co processed excipient is any combination of 2 or more excipients obtained by physical co processing that does not lead to the formation of covalent bonds. As people in the pharmaceutical industry know, acceptance of something new or different can move at a very slow pace. Co processed excipients help to overcome the deficiencies occurring with the use of general grade excipients. Identifying the excipients group to be co processed by carefully studying the material characteristics and functionality requirements 2. Definition of coprocess excipients it is a combination of two or more excipients designed to physically modify their properties in a manner not achievable by simple physical mixing, and without significant chemical change. Coprocessed excipients combination of two or more compendial or non compendial excipients to physically modify their properties. Examples of coprocessed directly compressible excipients are given in table 2. The following study aimed to characterise a range of coprocessed excipients that may prove suitable for dispersible tablet formulations prepared by direct compression. It emphasizes on the different examples of functional excipients also called as co processed excipient available in market such as ludiflash, pharmburst, and f melt. A novel directly compressible dc co processed excipient with improved functionality and masking the undesirable properties of individual excipients was developed without any chemical modification by using simple laboratory technique. For the development of coprocessed excipient, release retarding polymers.
Most important characteristics are the binding and blending properties of the co processed excipients, which must be better than those of a physical mixture of the starting materials. The author concluded that the co processed excipients were inferior compared with microcrystalline cellulose in a tableting for paracetamol, resulting largely from poor flow 60. Coprocessed excipients are adequate for direct compression since they become multifunctional and thus, their dilution potential is high eliminating the need for many excipients in a formulation. It is a coprocessed lactose starch for fillerbinder having strong disintegrant properties. Multifunctional coprocessed excipients for improved. All the tested excipients are prepared by the spray drying technique and are suitable for the direct compression. A blend of crospovidone and sodium starch glycolate in the ratio of 1. Nine excipients, selected based on successful manufactur. Recognition the excipient group to be co processed by carefully study.
The coprocessed excipients retain favourable attributes, and are supplemented with new ones. Co processed excipients were lubricated and compressed into 10. The formulations with 55% coprocessed excipients involving 3% 0. Advantages provide a single excipient with multiple functionalities. The utility of the coprocessed excipients can easily be demonstrated by formulating the tablets. Coprocessed excipients been developed primarily to address the issues of flowability, compressibility, and disintegration potential, with fillerbinder combinations being the most commonly tried. The tablet formulation guide a roadmap to excipient selection. Coproccessed excipients with enhanced direct compression. Co processed excipients offer the option of using a single excipient with multiple functional properties, thereby reducing the number of excipients in inventory.
The general monograph on coprocessed excipients will. Although co processed excipients are more costly, the overall product cost decreases because of improved functionality and fewer test requirements compared with. 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. Coprocessed excipients definition a coprocessed excipient is any combination of 2 or more excipients obtained by physical coprocessing that does not lead to the formation of covalent bonds. Now, more than 20 years after one of the first coprocessed excipients was patented, several newer coprocessed excipients are being commercialized. Coprocessed excipients for dispersible tabletspart 2.
Biswajit panda 1, abhinav raoot 1, vaishali kilor 1, nidhi sapkal 2. According to verified market research, the global co processed excipients market is growing at a faster pace with substantial growth rates over the last few years and is estimated that the market will grow significantly in the forecasted period i. The advantages, limitations, basis for the selection of excipients to be coprocessed, methods of coprocessing and regulatory perspective of coprocessed excipients are also briefly discussed. For the development of co processed excipient, release retarding polymers.
Maize starch and lactose were added as disintegrant and filler respectively and the mixer operated. By coprocessing two excipients, formulators can produce an excipient with superior properties as compared to the individual ingredients. Properties of coprocessed excipients absence of chemical change improved flow properties improved compressibility reduced lubricant sensitivity 18 19. Qualification of excipients for pharmaceutical use. Today, a large number of coprocessed excipients are available in pharmaceutical market, for example, prosolv, starlac, advantose fs95, avicel ce15, ludipress, etc. Coprocessed excipient workshop drs revisions bac rcm. Coprocessed excipients as a new generation excipients with multifunctional activities. Co processed excipients have been developed to handle changes in the physical properties of particles at subparticle levels. The flowability of coprocessed mannitolpeg was increased in the range of 6. Waste materials used for coprocessing are referred to as. Coprocessed excipients with combination of two or more existing excipients at subparticle level interaction will provide an attractive tool for developing high functionality excipients. Preparation of the coprocessed excipient superdisintegrant the coprocessed superdisintegrating agent was prepared by solvent evaporation method. Jun 18, 2018 co processed excipients may enhance functionality and reduce drawbacks of traditional excipients for the manufacture of tablets on a commercial scale.
Development of novel multifunction directly compressible. Excipient technology, coprocessing, coprocessed excipients. Gohel lallubhai motilal college of pharmacy, navarangpura, ahmedabad, india pranav d jogani usv limited, b. Coprocessed excipients been developed primarily to address the issues of. These coprocessed excipients have high functionalise compared to individual excipients such as better flow property, compressibility, reduced lubricant sensitivity. Coprocessed excipients may enhance functionality and reduce drawbacks of traditional excipients for the manufacture of tablets on a commercial scale.
Manipulation in the functionality of excipient is provided by the coprocessing of two or more existing excipients. Coprocessed excipients are believed to bring a drastic change in the field of pharmaceutical research. S electing the proper excipients is critical to the success of any tablet formulation. Ipec europe develops and publishes guidelines to promote the best use of excipients. Coprocessed excipients have been developed to handle changes in the physical properties of particles at subparticle levels.
Jan 28, 2020 co processed excipients have been developed to handle changes in the physical properties of particles at subparticle levels. Coprocessed excipients, where in, excipients are combined by virtue of subparticle level interaction have provided an attractive tool for developing high functionality excipients. Review on novel pharmaceutical coprocessed excipients. Coprocessing, excipients, mannitol, orally disintegrating dosage form. Xray diffraction analysis result of coprocessed had similiar pattern with mannitol. Evaluate the particle size required for co processing. Coprocessed excipients should follow proposed criteria established to define when usp would consider advancing a prospective new monograph for a coprocessed excipient into. Co processed excipients are a combination of two or more excipients designed to physical mixing and without significant chemical change. Development of novel multifunction directly compressible co. Design and characterization of oral dispersible tablets of. Coprocessing, excipients, mannitol, orally disintegrating dosage for. Ijprjindian jornal of pharmaceutical science and research, 41, pp. Development of coprocessed excipients in the design and. Definition of co process excipients it is a combination of two or more excipients designed to physically modify their properties in a manner not achievable by simple physical mixing, and without significant chemical change.
These criteria were developed to differentiate multicomponent coprocessed excipients from the more commonly encountered excipients that have been the norm in. Most of these excipients have been developed using spray drying technique. These co processed excipients have high functionalise compared to individual excipients such as better flow property, compressibility, reduced lubricant sensitivity. Formulating dispersible tablets using coprocessed excipients could signi.
Novel co processess excipients to improve tabletting performance,european journal of biomedical and pharmaceutical sciences,43,pp. Paracetamol tablets were prepared by dc using the formula in table 1. Coprocessed excipients for dispersible tabletspart 1. Co processing 4 co processing is a process in which 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 author concluded that the coprocessed excipients were inferior compared with microcrystalline cellulose in a tableting for paracetamol, resulting largely from poor flow 60. Excipient mixtures in co processing are produced to make use of the advantages of each component and to overcome specific disadvantages, if any. Levis evaluated coprocessed microcrystalline cellulose sodium lauryl sulphate prepared by an ultrasonic homogenization process followed by spray drying. The co processed excipients retain favourable attributes and are supplemented with new. The material characteristics and functionality required. Most of the co processed excipients however had less than 30% insoluble components, with the only exception of avicel hfe102. Comprehensive study of coprocessed excipients f melts. Coprocessed excipients are believed to bring a drastic change in the field. Large differences were found between coprocessed excipients, with avicel hfe102 showing the greatest proportion of insoluble material 87. Feb 25, 20 co processing methodologyexcipient selection on the basis of material characteristics selection of proportion of excipients homogenous dispersion or solution co drying co processed excipient 16 17.
Coprocessed excipients are a mixture of two or more existing excipients at subparticle level, offer substantial benefits of the incorporated. A coprocessed excipient comprising particles constituted by a mannitol and polyvinylpyrrolidone solid dispersion pvp in a percent ratio ranging between 75. The coprocessed excipients retain favourable attributes and are supplemented with new. As developing new excipients can be timeconsuming and expensive from a safety perspective, manufacturers see coprocessing of already approved excipients as an attractive alternative. Coprocessed excipients are expected to play a key role in the production of new chemical entities nces, according to bcc research. Marg, govandi, mumbai, india received 16 november 2004, revised 28 january 2005, accepted 31 january 2005, published 16 april, 2005. Coprocessed excipients could provide improved organolept. Excipient technology, co processing, co processed excipients. Co processed excipients, where in, excipients are combined by virtue of subparticle level interaction have provided an attractive tool for developing high functionality excipients. Pdf pharmaceutical excipients 6th jonas bravo academia. Cost is another factor to be considered in the selection of co. Coprocessed excipients are formulated on the base of.