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Pediatric Taste Masking

API & Drug Product Development >> Preformulation & Material Science >> Taste Masking

Quotient Sciences has extensive knowledge and capabilities to provide unique integrated development solution of acceptable, palatable pediatric formulations which is a key feature within the industry, driven by patient needs and regulatory requirements.

Taste & Odor Masking

API & Drug Product Development >> Preformulation & Material Science >> Taste Masking

Capsugel uses an array of specialized taste masking technologies and formulation approaches to address the bitter taste of many APIs in oral dosage forms. We are uniquely differentiated in having industry-leading expertise in innovative taste and odor masking approaches and enabling technologies.

Pediatric Taste Assessment

API & Drug Product Development >> Preformulation & Material Science >> Taste Masking

Quotient Sciences has extensive knowledge and capabilities to provide unique integrated development solution of acceptable, palatable pediatric formulations which is a key feature within the industry, driven by patient needs and regulatory requirements.

Taste Masking By Micro-Pelletizing of APIs

API & Drug Product Development >> Preformulation & Material Science >> Taste Masking

Glatt has many years of experience and expertise in the taste masking of APIs. With our technologies and formulation approaches, we are able to achieve effective taste masking of drugs. A proven approach is the micro-pelletizing of APIs with the subsequen

Taste Masking Capabilities by Hot Melt Extrusion

API & Drug Product Development >> Preformulation & Material Science >> Taste Masking

AbbVie advances your science like we would our own, with customized pharmaceutical hot melt extrusion services that include taste masking capabilities.

Taste-Masking

API & Drug Product Development >> Preformulation & Material Science >> Taste Masking

Aizant's scientists use Quality-By-Design (QbD) tools at all stages of formulation development. Design of experiments (DOE) along with risk assessment strategies allows us to design our experimental plan.

Formulcoat®

API & Drug Product Development >> Preformulation & Material Science >> Taste Masking

It is a patented and innovative coating process-application is taste masking of API but FORMULCOAT® can also be used for controlled or targeted release, to protect a sensitive API or to isolate it.

Development of Taste Masked Orodispersible Powder

API & Drug Product Development >> Preformulation & Material Science >> Taste Masking

GVK BIO adopts a comprehensive, time-bound strategy in developing stable products that are efficient in all quality aspects.

What is Pediatric Taste Masking? Taste masking is a method used to improve not only the taste of bitter APIs in formulated drug products, but also mouth feel (smooth vs. gritty) and the overall acceptability of medications to patients. It can be achieved in various ways. Common methods include changing the API to a different form (e.g., drug freebase, salt, or pro-drug) that is less bitter; using sweeteners, buffers, taste modifiers, or aromas to reduce aversive sensory attributes; and complexing the API to prevent its interaction with taste receptors, such as with cyclodextrins and ion exchange resins. Taste masking technology for pediatric formuations are an important stag of preformulation study, an API can be physically encapsulated through application of a coating (or coatings) to a drug particle or tablet, the use of barrier membranes, or the formation of solid dispersions via spray drying or hot-melt extrusion. Another potential method involves blocking of taste receptors directly or along the signaling pathway. Taste masking of pediatric formulation is important because poor patient adherence often leads to worsening health and poor outcomes, along with increased costs across the healthcare system. A broader range of taste-masking technologies is required for the growing number of different dosage forms and drug-delivery approaches in use and under development today to meet the unique and specialized needs of different patient populations. Pediatric patients consists of subgroups from babies to teenagers, each with its own requirements. Taste masking technologies for Pediatric patients makes formulation better for those drugs that may have difficulty swallowing. Patients with neurological conditions may resist taking medications if the drug product is not easy to take. Taste masking formulation manufacturers CMOs and service providers focused on taste masking are overcoming a range of challenges--from regulatory hurdles to an ability to accurately predict and measure taste-masking performance--to develop technologies suitable for the growing range of dosage forms and delivery systems. The mechanisms of taste-masking techniques often rely on two major approaches: the first is to add sweeteners, flavors, and effervescent agents to mask the unpleasant taste, and the second is to avoid the contact of bitter/unpleasant drugs with taste buds. In the past few years, significant progress has been made in the area of taste-masking by applying novel strategies and techniques, such as hot-melt extrusion and microencapsulation. The development of acceptable, palatable pediatric formulations is a key feature within the industry today, driven by patient needs and regulatory requirements.The following presents an overview and current status of the industrial approaches and platforms used for taste-masking in oral dosage forms. Perception of taste Taste is a sensory response to chemical stimulation of taste receptors by tastants. There are five basic tastes that have been identified: salty, sweet, sour, bitter, and umami. Of these, bitter taste perception is considered the most complex modality. Earlier theory of taste perception was based on taste map, wherein distinct areas of the tongue were shown to respond to certain stimuli. However, according to the latest theory, all taste buds respond to all stimuli. Taste buds are onion-shaped structures comprising 50 to 100 taste receptor cells. The tastants interact with surface proteins (as in the case of sweet and bitter taste) known as taste receptors or with pore-like proteins (as in the case of sour and salty taste) called ion channels. Engineering Microparticles for Taste-Masking and Controlled lead to electrical changes within the taste cells that trigger them to send chemical signals that transform into neurotransmission to the brain. The brain then perceives the signal as bitter, salty, sweet, sour, or umami. Taste Masking Techniques for Pediatric Formulations The commonly used industrial techniques/methods of taste-masking of pediatric formulations include organoleptic methods, polymer coating, hot-melt extrusion, microencapsulation, complexation, and spray-drying. Organoleptic Methods This is the simplest and most convenient method of taste-masking. It involves adding a combination of sweeteners (sucralose, aspartame) and flavors (orange, mint) to mask the unpleasant taste of low to moderately bitter actives. In addition, effervescent agents (sodium bicarbonate, citric acid) can also be added to improve the mouth feel. Some formulations may include a bitterness blocking agent that masks the bitter taste or the perception of bitter on the tongue. Such bitter blockers may include adenosine monophosphate, lipoproteins, or phospholipids. Taste masking Tablet formulation manufacturers CMOs and CDMOs and service providers focused on taste masking are overcoming a range of challenges--from regulatory hurdles to an ability to accurately predict and measure taste-masking performance--to develop technologies suitable for the growing range of dosage forms and delivery systems.These agents compete with the bitter active to bind to the G-protein coupled receptors on the tongue (receptor sites that detect bitter), thus suppressing the bitter taste. It has also been found that sodium chloride can be added to a formulation to mask bitterness as in the preparation of pioglitazone hydrochloride orally disintegrating tablets. Polymer Coating The simplest option is direct coating that provides a physical barrier over the drug particles with a composition that is insoluble in the mouth. Hydrophobic or hydrophilic polymers, lipids, and sweeteners can be used as coating materials, alone or in combination to produce a single or multi-layer coat. Pediatric formulation requires taste masking for oral formulations Methacrylic acid and methacrylic ester copolymers (Eudragit E-100, RL 30D, RS 30D, L30D-55, and NE 30D) have been effectively used for taste-masking with polymer coat levels varying from 10% to 40%, depending on the drug bitterness. Polymers for taste-masking pediatric drug products and Fluid bed is often the technique of choice. Most recently, alternate approaches such as application of molten lipids [glyceryl palmitostearate (Precirol® ATO-5, Gattefosse, France) and glycerol behenate (Compritol® 888-ATO, Gattefosse, France)] on the surface of drug particles has been used as a solvent-free alternative. Hot-Melt Extrusion Hot-melt extrusion (HME) offers a relatively newer approach to taste-masking and provides advantages such as absence of organic solvents in the process, fewer processing steps, continuous operation, and scale-up capabilities. For the purpose of taste-masking, the bitter active is mixed with other ingredients in a dry state. The mixture is filled in a hopper, conveyed, mixed, and melted by an extruder. Formulation of taste masked fixed dose combinations for paediatric.Poorly tasting paediatric medicines.The process subjects the materials to a heating process under intense mixing to obtain the taste-masked extrudates. The extrudate can then be milled or micronized to obtain taste-masked granules or particles, which are then incorporated into a suitable dosage form. Twin screw extruders are one of the most popular extruders and provide advantages such as short transit time, convenient material feed, high shear kneading, and less over-heating. Microencapsulation Microencapsulation is a technology with a long history in the pharmaceutical industry, and taste-masking represents an expanded area of its application. In principle, microencapsulation provides the opportunity to encapsulate the bitter active and thus prevent its contact with taste buds. Microcaps® is one such well-recognized technology that applies coacervation/phase separation to produce different encapsulated polymeric membranes. The process primarily consists of formation of three immiscible phases, formation of the coat, and deposition of the coat. Taste masking technology for pediatric dosage forms make sure that drug can be easily intake by children. Taste masking technology for pediatric dosage forms like taste masking of dispersible tablet and taste masking of oral syrup requires formation of the three immiscible phases is accomplished by dispersing the core particles in a polymer solution. Developing palatable formulations in the OTC/consumer health care industry. Use of Polymers for Taste Masking Pediatric Drug Products that uses phase separation is then induced by change in the temperature of polymer solution; change in the pH, addition of a salt, non-solvent, or by inducing a polymer-polymer interaction. This leads to deposition of the polymer coat on the core material under constant stirring. The core particles coated by the polymer are then separated from the liquid phase by thermal, crosslinking, or desolvation techniques leading to rigidization of the coat. Microcaps are used in conjunction with Advatab® compressed ODT technology. Bitter drug substances using a range of taste-modifying Substance forms taste masked drug formulations for pediatrics. Taste Masking Formulation Development and taste masking technology CMOs and CDMOs for manufacturing pediatric formulations. Taste masking agents for oral pediatric formulations are used for various antibiotics. Companies have an extensive track record developing age-appropriate dosage forms of aversive, bitter drug substances using a range of taste-modifying and taste-masking techniques without compromising on product stability and PK performance. Taste assessment and PK studies for pediatric formulation by using integrated GMP manufacturing and clinical testing platform, comies perform rapid, adaptive trials in humans to optimize taste attributes and/or PK performance to ensure clinical validation prior to proceeding to pivotal pediatric trials. Taste masking CDMOs, taste masking solution providers offers wide range of services for taste masking of pediatric tablets and taste masking of chewable tablets. Various flavoring agents are used to modify taste and make pediatric drug palatable. Complexation Cyclodextrins have been extensively used for taste-masking bitter drugs by forming inclusion complexes with the drug molecule. Cyclodextrins are unique bucket-shaped cyclic oligosaccharides containing at least six D-(+)-glucopyranose units attached by alpha-(1,4)-glucosidic bonds with a molecular structure of hydrophobic cavity and hydrophilic exterior. The formation of inclusion complexes and its type depends on several factors like drug properties, processes involved, the equilibrium kinetics, formulation excipients, and the desired final dosage form and delivery system. Taste-masking is achieved by the interaction of cyclodextrins with proteins of the taste buds or by inhibiting the contact of bitter drug molecules with taste buds. Taste masking CMOs, taste masking solution providers offers wide range of services for taste masking of pediatric oral solid dosage forms and taste masking of pediatric liquid dosage forms. Various flavoring agents are used to modify tasteand make pediatric drug palatable. Spray-Drying Spray-drying provides an alternate approach to taste-masking by applying a physical barrier coating. The bitter drug is either dissolved or dispersed along with the polymer in a suitable solvent followed by spray-drying. The process usually consists of three different steps: (1) atomization of feed into a spray, (2) spray-air contact (mixing and flow) followed by drying, and (3) separation of dried product from the air. The process provides the option of using aqueous and non-aqueous solvents. The dried product often includes granules or beads containing taste-masked encapsulated drug. Taste masking techniques for pediatric drugs offered by taste masking CMOs is required for pediatric formulations various services are taste masking for pediatric tablets, taste masking for pediatric solutions and suspensions these make the drug more palatable. The amount of polymer coat can sometimes retard the drug release, and therefore requires careful polymer selection and process design to afford taste-masking. Also, the formulation and processing can affect whether or not the polymer is “coated” on the surface or dispersed. The quality of taste-masking depends on providing a coat, not a dispersion. Some of the advantages of spray-drying include (a) less processing time being a single step process, (b) scale-up capability, and (c) wide variety in the choice of solvent and polymer. Taste Evaluation Tests Taste is a very subjective perception for Bitter Drugs. In vivo tests such as human panel testing and frog taste nerve responses can be used to evaluate taste of formulations. In human panel testing, large groups of healthy volunteers are asked to take bitter drug and then the taste masked formulation. Bitter Drugs taste masking are then asked to comparatively rate the formulation on various organoleptic properties. In frog taste nerve responses, glossopharyngeal nerve of bull frogs is connected to AC amplifier and responses to bitter drug and formulation are taken. Evaluating the taste masking effectiveness of various flavors in Pediatric formulation. The peak height obtained is used to assess taste masking. Taste masking and orally disintegrating tablets. Use of polymers for taste-masking pediatric drug products. In vitro methods such as spectrophotometry involve mixing of formulation to 10ml distilled water and then analyzing API concentration. If API concentration is below the threshold, sufficient taste masking is considered to be achieved. Formulation and Evaluation of taste masked oral suspension of pediatric formulations. The spectrophotometry method is not an absolute taste evaluation test. Another in vitro test involves usage of electronic (e) tongue to evaluate taste. Taste Masking Technologies in Oral Pharmaceuticals. The e-tongue emulates the three levels of biological taste recognition: the receptor level (taste buds in humans, probe membranes in the e-tongue), the circuit level (neural transmission in humans, transducer in the e-tongue), and the perceptual level (cognition in the thalamus in humans, computer and statistical analysis in the e-tongue). In e-tongue the formulation or API is evaluated against standard (e.g., quinine hydrochloride) and the software generates taste patterns that form the basis of evaluation. Pediatric Taste Masking for Oral Drug Delivery Drugs given orally include liquid dosage forms (solutions, suspensions, syrups and emulsions) as well as solid dosage forms including tablets, capsules, granules/sprinkles, chewable tablets, orodispersible tablets and controlled release tablets. The oral route of administration is the preferred route for patients of all ages for reasons of convenience and stability. Atibiotics have bitter taste, to improve its taste, taste masking technology for pediatric formulations is preferred. This step of formulation development at preformulation stage assures the drug to be more stable and palatable. Preformulation studies for taste masking of pediatric drug is an approach to provide palatable drug to children. Oral liquids The bitter taste associated with many drugs is thought to have evolved as a deterrent against ingesting toxic substances. The major barrier in development of oral liquid formulations is taste-masking of drugs as more than 90% of paediatricians in the US reported that a drug's taste and palatability were the greatest barriers to completing treatment. In some cases simple taste-masking is insufficient and more complex formulations are required to encapsulate the drug providing taste-concealing properties. Taste masking techniques for bitter drugs. The excipients used in the development of a product need to be safe and acceptable for use in children. Excipients are typically used to optimize the formulation of the medicine to improve palatability, shelf-life and/or manufacturing processes. There are certain excipients that should not be used in childrens' medicines as they can retard on-going organ development, for example, ethanol, propylene glycol, benzyl alcohol and parabens. It is also important to consider the electrolyte concentration when develop Solids for reconstitution The use of dispersible tablets, powders, granules, pellets or sprinkles for reconstitution is a popular strategy in paediatric formulation development as the solid product typically has better stability compared with a formulated liquid. However, these reconstituted products also need to be taste-masked. Reconstitution can occur either at the point of dispensing or at the point of administration depending on the product. Film Coating for Taste-masking of Pediatric Oral Solid. The instructions for reconstitution can be complicated for untrained individuals, yet it is important that the final product contains the correct dosage for the patient. If these solids for reconstitution are administered in the absence of water they are only appropriate for infants who are accepting solid food (typically >6 months). Taste masking for Pediatric formulation and product development. Acceptable, palatable pediatric formulations. Taste masking solutions for Pediatrics. For solids of a larger particle size the minimum age range may be higher owing to the risk of aspiration or choking medicines for neonates where renal function may be immature. Oral solid dosage forms – conventional tablets and capsules Conventional tablets are limited by their rigid dose content and the ability of the child to swallow a tablet. The general thinking is that children will accept tablets based on size, where a smaller tablet is more likely to be acceptable. Tablets can be scored to allow splitting to reduce their size yet this can result in inaccurate dosages within the fragmented tablets. Draft EMA guidance proposed that, ‘small tablets (i.e. tablets from 3 to 5?mm diameter, width or length whichever is the longest) will not be considered acceptable for children below the age of 2 years, medium sized tablets (i.e. tablets from 5 to 10?mm) for children below the age 6 years, large tablets (i.e. tablets from 10 to 15?mm) for children below the age of 12 years and very large tablets (i.e. tablets from 15?mm) for children below the age of 18 years’ 11, however, this recommendation was removed from the updated guidance document 7. Studies that investigated the use of mini-tablets (tablets ?3?mm) found that mini-tablets were a potential dosage form suitable for 2–6 year olds (based on placebo tablets 3?mm in diameter) 71. Additionally Spomer and co-workers found that very young children (6–12 months) were fully capable of swallowing mini-tablets of 2?mm diameter, often accepting them in preference to sweet liquid formulations. Chewable tablets and orodispersible formulations Chewable tablets and orodispersible formulations need to possess good organoleptic properties including a good mouth feel which is influenced by the drug's crystalline structure and solubility. The consequences of swallowing such tablets whole should be considered and it is preferable that their bioavailability is unaffected. WHO guidance suggests that they should be developed such that the label can state, ‘tablets that may be chewed or swallowed whole. Orodispersible tablets, oral lyophilisates and oral films are solid products that are designed to dissolve within the oral cavity. These products dissolve and disperse within the saliva for absorption either directly from the oral cavity or for absorption from the gastrointestinal tract following ingestion. The ratio of absorption from each of these sites can be important, particularly for drugs that show differences in bioavailability from each route, for example desmopressin.

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