Development and pharmaceutical performance of a novel co. The co processing of selected excipients are done in three ratios 8. Flow, compaction and tabletting properties of coprocessed. Feb 25, 20 properties of co processed excipients absence of chemical change improved flow properties improved compressibility reduced lubricant sensitivity 18 19. Few traditional excipients provide the functional characteristics, specifically powder flow and compactibility, required for robust direct compression tablet manufacture. Co processed excipient has received much more attention in the formulation development of various dosage forms, specially for tablet. Preparation of coprocessed excipients for controlledrelease. Wo2016046693a1 a coprocessed pharmaceutical excipient. Coproccessed excipients with enhanced direct compression. Coprocessed excipients cpes provide functional synergy with the convenience of reduced testing and scaleup.
Palatability and patient acceptability are critical attributes of dispersible tablet formulation. 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. Evaluation of a coprocessed excipient from cow bone powder. The requirements for safety and consistency of performance variability are the same for either type of processing. Coprocessed excipients are adequate for direct compression since they become multifunctional and thus. Co processed excipients are believed to bring a drastic change in the field. A co processed pharmaceutical excipient download pdf. The study was designed to determine compatibility of drug with different co processed excipients. Research is needed to streamline the process for approving new excipients especially for niche markets. Jan 22, 2021 after studying the effect of different factors on the co processed excipients functionality, the formulation f2, prepared using 10% of aa, 90% of mcc and 70% of water, named cop aamcc, was chosen as the best one regarding its physical properties and its tableting and disintegration performance. Co processing is another way that new excipients are coming to market without undergoing the rigorous safety testing of a completely new chemical. By producing avicel concurrently with other common excipients, synergies are created above what standard products and blends can offer. Excipient technology, co processing, co processed excipients. Avicel co processed products are high functionality excipients offering improved powder flow, granule properties, tablet compression, and mouth feel.
Pharma solutions avicel coprocessed product selection guide. Fillerbinder can overcome the weakness of the physical properties of the active ingredients to make them compressible with direct compression method. Properties of co processed excipients absence of chemical change improved flow properties improved compressibility reduced lubricant sensitivity 18 19. Evaluation of a co processed excipient from cow bone powder and gelatin for use in direct compression tableting with abstract, chapters 15, references, and questionnaire. Recent advances in coprocessed apis and proposals for. The excipient was prepared by co processing gelatinized maize starch with sodium carboxymethyl cellulose. Direct compression is the preferred method for tablet formulation due to its obvious advantages such as shorter processing time involving fewer unit operations carlin, 2008. Co processed excipients deliver functional synergies to address formulation challenges with simplified, single ingredient solutions.
One with alphalactose monohydrate and powdered cellulose in 75. Introduction fillerbinder is a kind of excipient of direct compression tableting method 1. Novel coprocessed excipients of mannitol and microcrystalline. Pdf co processing is currently of interest in the generation of highfunctionality excipients for tablet formulation. Characterisation of a novel, multifunctional, coprocessed excipient. 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. Coprocessed excipient for direct compression designed for. Multifunction directly compressible co processed excipient hfe. Also, wide number of oral formulations in the market such as syrups and tablets are fueling growth of sugarbased excipients. A co processed powder was formed by adsorption of solid lipid nanoparticles sln as a controlledrelease film onto a functional excipient, in this case, dicalcium phosphate dihydrate dpd, for direct compression. As the chemical change is absent, they are considered to retain the gras generally regarded as safe status.
We have applied our extensive manufacturing and applications expertise to develop the leading range of co processed excipients. Critical issues in the use and evaluation of excipients in. The international pharmaceutical council coprocessed. Aug 10, 2018 overview of marketed co processed excipients co peocessed excipient components % manufacturer advantages ludipress lctose monohydrate 93. Two co processed excipients were used for our research. Jul 17, 2020 the development of novel excipients by co processing has witnessed a surge in the last few decades. Co processing of excipients in the pharmaceutical industry can be dated back to the late 1980s with the introduction of co processed microcrystalline cellulose and calcium carbonate 9, followed by cellactose in 1990, which is a co processed combination of cellulose and lactose. Coprocessed excipients market is projected to reach usd 2641.
Formulating dispersible tablets using co processed excipients could signi. Design and development of a microwave generated lactose. One such product is granfillerd, a co processed excipient for direct compression odts. The paper, authored by vinit nigudkar, a staff formulation scientist specializing in nutraceuticals and dietary supplements, focuses on the use of co processed. Co processed excipient for direct compression designed for orally disintegrating tablets in recent years, new excipients and excipient blends have enabled manufacturers to produce odts using conventional equipment, i. Innophos, a leading international producer of excipients for the pharma and dietary supplement industries, today announced the release of its latest whitepaper entitled, co processed multifunctional excipients in tableting. Completely dried kbr and samples drug and excipients taken in 9. Co processed excipients are a combination of two or more excipients designed to physical mixing and without significant chemical change.
This document offers best practice and voluntary guidance on the development, manufacture and use of coprocessed excipients. The ipec europe coprocessed excipient guide for pharmaceutical. May 07, 2011 co processing of excipients in the pharmaceutical industry can be dated back to the late 1980s with the introduction of co processed microcrystalline cellulose and calcium carbonate 9, followed by cellactose in 1990, which is a co processed combination of cellulose and lactose. Rice is one of the most important crops in nigeria 9.
Co processed excipients are expected to play a key role in the production of new chemical entities nces, according to bcc research. Sugarbased excipients market size share scope growth. As with other excipients, co processed excipients may be manufactured using either batch or continuous processing. Studies to predict the effect of pregelatinization on. Us8932629b2 coprocessed microcrystalline cellulose and sugar. New era in pharmaceuticals find, read and cite all the. The co processed excipients retain favourable attributes, and are supplemented with new ones. They can benefit in terms of manufacturability and developability compared to traditional blends of their individual components due to the process used to prepare the combination product 1,2. Co processed excipients offer the option of using a single excipient with multiple functional properties, thereby reducing the number of excipients in inventory. May 30, 2015 ludipress is a commercially available spraydried co processed excipient containing 93. Compaction and tableting properties of composite particles of. Comprehensive study of co processed excipients f melts. Jan 28, 2020 coprocessed excipients have been developed to handle changes in the physical properties of particles at subparticle levels. Pdf comparative analysis of coprocessed starches prepared.
Several co processed excipients for immediate release formulation are available on the market e. Although co processing can be a viable route to a functional excipient that provides superior flow and direct compression tableting, with bestinclass controlled release, generally, the range of largevolume co processed excipients will be limited, says dr. Co processed excipients help to overcome the deficiencies occurring with the use of general grade excipients. It involves a thorough understanding of material properties and.
Original research article development of novel multifunction. As a result, modifying traditional excipients may be necessary. Advantages provide a single excipient with multiple functionalities. 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. Coprocessed excipients market is projected to reach usd 2,641. These co processed excipients have high functionalise compared to individual excipients such as better flow property, compressibility, reduced lubricant sensitivity. The excipient was prepared by coprocessing gelatinized maize starch with sodium.
Developing orally disintegrating tablets odts is a worldwide trend. Boxbehnken experimental design was worked out to optimize the proportion of the primary excipients for the coprocessed excipient. Coprocessed excipients market size, share, opportunities. Co processed particles of microcrystalline cellulose and mannitol were fabricated by spray drying technique to be used as a direct compression excipient in fast. The behavior of the co processed excipients fit the higuchi model for matrix systems. But there is no commercially available co processed excipient for. The co processing can be performed by different means like hot melt extrusion, solid dispersion, spray drying, pregelatinization and retrogradation 3, 4. Co processed excipients are adequate for direct compression since they.
A novel coprocessed directly compressible releaseretarding. This may be accomplished through spraydrying, agglomeration, rollerdrying, or co process. Review on novel pharmaceutical coprocessed excipients. The ipec co processed excipient guide for pharmaceutical excipients. Most introductions are co processed blends of old excipients. Co processing is defined as the combination of two or more excipients by a physical process. The purpose of the study was to develop a novel, directly compressible, co processed excipient capable of providing a controlledrelease drug system for the pharmaceutical industry. Growing use of co processed excipients in the pharmaceutical industry and an increasing number of pediatric and geriatric patients across the globe are boosting use of sugarbased excipients.
Pdf on jan 1, 2019, ashok thulluru and others published co processed excipients. The selected ratio of co processed excipients were subjected to pre. All other reagents used were of analytical grade and water was double distilled. Co processed adjuvant lacks the official acceptance in pharmacopoeia. Optimization direct compressions co processed excipient k 30. Jun 25, 2018 co processed excipients are the combination of two or more excipients, often prepared by spraydrying, wet granulation or co crystallisation. To characterise a novel multifunctional pharmaceutical excipient and investigate its effect on paracetamol. Download fulltext pdf download fulltext pdf read fulltext. In conclusion, this optimized co processed excipient could provide a tool that will help resolve the lack of new, functional excipients for the pharmaceutics industry that are free of chemical changes and enhance the properties of the raw excipients. Processed excipients for direct compression of paracetamol tablets.
Fine grade engineered microcrystalline cellulose excipients. Novel coprocessed excipients composed of lactose, hpmc, and. Co processed excipients are believed to bring a drastic change in the field of pharmaceutical research. Formulation and evaluation of diltiazem hcl fast dissolving. This co processed product is collected to characterize and evaluate to know its flow properties and functionality. Comprehensive study of coprocessed excipients f melts. Although co processed excipients are more costly, the overall product cost decreases because of improved functionality and fewer test requirements compared with. Major limitation of co processed excipient mixture is that the ratio of the excipients in a mixture is fixed and in developing a new formulation, a fixed ratio of the excipients may not be an optimum choice for the api and the dose per tablet under development 18.
Co processing as a particle engineering technique has proven to be a useful strategy in improving the functionality or performance of existing single component excipients like lactose, microcrystalline cellulose, and starch 3, 4. Coprocessed excipients for dispersible tabletspart 2. Dec 01, 2020 this limited feasibility can be overcome by co processing of two or more existing excipients to yield a co processed excipient with desired characteristics. Coprocessed excipients are believed to bring a drastic change in the field of pharmaceutical research. In recent years, new excipients and excipient blends have enabled manufacturers to produce odts using conventional equipment, ie, blenders and tablet presses.
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