Advanced release technologies for improved present and future pharmaceutical formulations

As active pharmaceutical ingredients (APIs) require different drug delivery systems, from edibles such as gummies to taste masked, controlled release suspensions, DuPont Water Solutions ion exchange resins enable effective drug formulation. In addition to modified release applications the ion exchange excipients have a broad range of uses from tablet disintegration and drug stability to abuse deterrent and solubility enhancement. Our excipients are designed to help solve customer challenges and address some of the most pressing pharmaceutical trends with an extensive track record of innovation and reliable performance.

For decades our ion exchange resins have also been used as APIs.  Duolite™ AP-143 Cholestyramine Resin USP has been taken orally by patients around the world to reduce blood cholesterol while DuPont™ AmberLite™ IRP69 Sodium Polystyrene Sulfonate USP helps with hyperkalemia by helping to control blood potassium levels.  The unique functionality of ion exchange resins combined with our vital expertise in polymer science, formulation design, and drug synthesis allows us to support current and future needs across the pharmaceutical and life sciences.  

 
 
 
 
 
 
 
 
 
 
 
 

Applications for AmberLite™ and Duolite™ Ion Exchange Resins

Our ion exchange resins are well-known and globally recognized excipients as well as active pharmaceutical ingredients (APIs) with a long history of safe use. Our portfolio of resins encompasses AmberLite™ IRP69 (Sodium Polystyrene Sulfonate, USP), AmberLite™ IRP64 (Polacrilex Resin), AmberLite™ RP88 (Polacrilin Potassium NF), and Duolite™ A143 (Cholestyramine Resin) families. AmberLite™ and Duolite™ have shown to be safe as effective excipients and are used in commercial drug formulations, throughout the world. AmberLite™, a cationic exchange resin, and Duolite™, an anion exchange resin, are used in suspension formulations for controlled release and taste-masking in the geriatric and pediatric populations that offer improved patient compliance in formulations like suspensions and Orally Disintegrating Tablets (ODTs). Ion Exchange Resins are polymers capable of exchanging ions within a solution that are passed through them. In pharmaceutical applications, this functionality can be used to create more powerful, functional excipients that create a drug-resin complex (resinate) with a direct impact on the availability of a drug. Learn more about AmberLite™ and Duolite™ Ion Exchange Resins applications below.
Taste-Masking
Tablet Disintegration
Modified Release
Drug Stability
Solubility Enhancement
Abuse Deterrence
Cholestyramine
Sodium Polystyrene Sulfonate

Ion-exchange resins for orally disintegrating tablets and other dosage forms offer advantages over taste-masking strategies that depend on sweeteners or flavor additives, which may be undesirable for patients with diabetes, fructose intolerance, or aspartame intolerance (i.e., phenylketonurics). Poorly adsorbed flavor additives and non-digestible sweeteners can also produce laxative effect. Limiting dissolution of API in patient’s mouth is an alternative that can be achieved via API-complexation using ion-exchange resins. Method binds API so release in salivary pH is insufficient to produce bitter taste, thus improving compliance. Moreover, DuPont has designed new equipment for buccal dissolution that allows the selection of taste masking formulations. This technology was specially developed to help formulators to optimize their taste masking formulations in vitro and show differences between formulations.

Numerous drugs are formulated in the form of tablets. Their efficiency depends on the speed at which the tablet disintegrates in the stomach. AmberLite™ IRP88 swells easily in an aqueous medium and thus rapidly disintegrates the tablet by creating internal pressure. The use of AmberLite™ IRP88 offers advantages in term of tablet hardness when it is submitted to a high level of compression, preventing them to break or dust during packaging and shipping. Carboxymethyl cellulose and alginates are adhesive in nature and thus not very efficient in overcoming the bonding of particles in compressed tablets whereas AmberLite™ IRP88 shows a minimal adherence rate and is therefore more effective for such formulations.

Controlled release (CR) oral drug delivery systems are employed to improve patient compliance and therapeutic outcomes. Modified release (MR) dosage forms can be utilized to reduce the number of times the patient has to administer medication over the course of the day. They can also be utilized to prolong the time in which the systemic blood concentration remains within the therapeutic window, while avoiding potential adverse events from spikes in drug concentration.

We offer a portfolio of functional polymeric ion exchange excipients, which are utilized to formulate various modified release dosage forms like tablets, capsules, suspensions and barrier-coated multiparticulates. Our strength is our commitment to quality and consistency. Our products are fully certified for pharmaceutical use, and offer innovations for all kinds of drug delivery system designs.

Some active pharmaceutical ingredients (APIs) are sensitive to the effects of heat, light and oxygen. DuPont offers solutions to protect APIs from environmental conditions and increase the stability of the ingredients in a variety of formulations to guarantee a drug’s long-term quality, efficacy and safety.

AmberLite™ and Duolite™ resins can be used to enhance the solubility and dissolution of poorly soluble drugs. In the case of poorly soluble ionizable drugs, the release of drug from a resinate can be faster than the rate of dissolution of the solid form of the drug. Hence, with AmberLite™ or Duolite™, one can increase the rate at which poorly soluble drugs dissolve. AmberLite™ and Duolite™ resins provide a unique solution to control API release in tablets and liquid suspensions and can be combined with other excipients to provide targeted release profile.

Over the past decade, the abuse of prescription opioid drugs became a national health crisis in the United States. Pharmaceutical companies, the Food and Drug Administration, and other government agencies are confronting opioid abuse by developing and commercializing various abuse-deterrent drug delivery technologies. AmberLite™ and Duolite™ ion exchange resins prevent immediate release of drugs in a variety of formulations even during elicit use and manipulation. These resins bind the API and prevent immediate release even when the formulation is crushed, maintaining the intended rate of absorption.

Your body needs cholesterol to build healthy cells, but high levels of cholesterol can increase your risk of heart disease. Duolite™ AP-143 Cholestyramine Resin USP resin works as an API by exchanging anions for bile acids in the intestine. The liver then produces more bile acids to replace those that have been lost. Because the body uses cholesterol to make bile acids, this reduces the amount of LDL cholesterol circulating in the blood while the resin passes out of the body without being absorbed.  Cholestyramine has been taken orally by patients around the world to reduce blood cholesterol for decades.

The body needs a delicate balance of potassium to help the heart and other muscles work properly.  AmberLite™ IRP69 Sodium Polystyrene Sulfonate USP is a cation-exchange resin used to treat high levels of potassium in the blood, also called hyperkalemia.  AmberLite™ IRP69 resin works by exchanging the sodium ions with the potassium ions present in the large intestine and then passes out of the body without being absorbed taking the potassium with it. 

  • Taste-Masking +

    Ion-exchange resins for orally disintegrating tablets and other dosage forms offer advantages over taste-masking strategies that depend on sweeteners or flavor additives, which may be undesirable for patients with diabetes, fructose intolerance, or aspartame intolerance (i.e., phenylketonurics). Poorly adsorbed flavor additives and non-digestible sweeteners can also produce laxative effect. Limiting dissolution of API in patient’s mouth is an alternative that can be achieved via API-complexation using ion-exchange resins. Method binds API so release in salivary pH is insufficient to produce bitter taste, thus improving compliance. Moreover, DuPont has designed new equipment for buccal dissolution that allows the selection of taste masking formulations. This technology was specially developed to help formulators to optimize their taste masking formulations in vitro and show differences between formulations.

  • Tablet Disintegration +

    Numerous drugs are formulated in the form of tablets. Their efficiency depends on the speed at which the tablet disintegrates in the stomach. AmberLite™ IRP88 swells easily in an aqueous medium and thus rapidly disintegrates the tablet by creating internal pressure. The use of AmberLite™ IRP88 offers advantages in term of tablet hardness when it is submitted to a high level of compression, preventing them to break or dust during packaging and shipping. Carboxymethyl cellulose and alginates are adhesive in nature and thus not very efficient in overcoming the bonding of particles in compressed tablets whereas AmberLite™ IRP88 shows a minimal adherence rate and is therefore more effective for such formulations.

  • Modified Release +

    Controlled release (CR) oral drug delivery systems are employed to improve patient compliance and therapeutic outcomes. Modified release (MR) dosage forms can be utilized to reduce the number of times the patient has to administer medication over the course of the day. They can also be utilized to prolong the time in which the systemic blood concentration remains within the therapeutic window, while avoiding potential adverse events from spikes in drug concentration.

    We offer a portfolio of functional polymeric ion exchange excipients, which are utilized to formulate various modified release dosage forms like tablets, capsules, suspensions and barrier-coated multiparticulates. Our strength is our commitment to quality and consistency. Our products are fully certified for pharmaceutical use, and offer innovations for all kinds of drug delivery system designs.

  • Drug Stability +

    Some active pharmaceutical ingredients (APIs) are sensitive to the effects of heat, light and oxygen. DuPont offers solutions to protect APIs from environmental conditions and increase the stability of the ingredients in a variety of formulations to guarantee a drug’s long-term quality, efficacy and safety.

  • Solubility Enhancement +

    AmberLite™ and Duolite™ resins can be used to enhance the solubility and dissolution of poorly soluble drugs. In the case of poorly soluble ionizable drugs, the release of drug from a resinate can be faster than the rate of dissolution of the solid form of the drug. Hence, with AmberLite™ or Duolite™, one can increase the rate at which poorly soluble drugs dissolve. AmberLite™ and Duolite™ resins provide a unique solution to control API release in tablets and liquid suspensions and can be combined with other excipients to provide targeted release profile.

  • Abuse Deterrence +

    Over the past decade, the abuse of prescription opioid drugs became a national health crisis in the United States. Pharmaceutical companies, the Food and Drug Administration, and other government agencies are confronting opioid abuse by developing and commercializing various abuse-deterrent drug delivery technologies. AmberLite™ and Duolite™ ion exchange resins prevent immediate release of drugs in a variety of formulations even during elicit use and manipulation. These resins bind the API and prevent immediate release even when the formulation is crushed, maintaining the intended rate of absorption.

  • Cholestyramine +

    Your body needs cholesterol to build healthy cells, but high levels of cholesterol can increase your risk of heart disease. Duolite™ AP-143 Cholestyramine Resin USP resin works as an API by exchanging anions for bile acids in the intestine. The liver then produces more bile acids to replace those that have been lost. Because the body uses cholesterol to make bile acids, this reduces the amount of LDL cholesterol circulating in the blood while the resin passes out of the body without being absorbed.  Cholestyramine has been taken orally by patients around the world to reduce blood cholesterol for decades.

  • Sodium Polystyrene Sulfonate +

    The body needs a delicate balance of potassium to help the heart and other muscles work properly.  AmberLite™ IRP69 Sodium Polystyrene Sulfonate USP is a cation-exchange resin used to treat high levels of potassium in the blood, also called hyperkalemia.  AmberLite™ IRP69 resin works by exchanging the sodium ions with the potassium ions present in the large intestine and then passes out of the body without being absorbed taking the potassium with it. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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