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    Overview of the controlled release formulation development and manufacturing of complex modified dosage forms including modified release tablets

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    Overview of controlled release formulation development and manufacturing of complex modified dosage forms including modified release tablets

    Q1. What is formulation development and why is it important?

    Fully integrated CDMOs offer CDMO services including drug formulation, development, and delivery. Pharma CDMOs which work on formulation development studies determine the specialist dosage forms, composition, and development and manufacturing routes, fundamental to drug product formulation. Pharmaceutical formulation development and contract services at times pertain to capsules filled with tablets, powder, granules, pellets, etc. and cover several other drug formulations. 

    Essentially, formulation development and manufacturing are performed in order for drugs to be effectively delivered to patients. The importance of these specialized services is exemplified by industry analysts, who speak to the advancement of formulation development & manufacturing in drug delivery platforms and personalized medicines.

    Q2. How are oral solid dosage forms such as capsules and tablets formulated?

    Oral solid dosages such as tablets and capsules employ oral drug delivery mechanisms, while drugs that are not orally administered use parenteral drug delivery systems. Traditional development and manufacturing of solid oral dosage forms starts with preformulation studies testing the physiochemical characteristics of active pharmaceutical ingredients (API) and excipients in order to design the desired formulation with process optimization. 

    Following preformulation, drug-excipient compatibility tests and prototype stability studies are conducted. The oral solid dosage forms are then subjected to batch scale-up after which they are transferred to commercial manufacturing units. The end goal of the formulation development of oral solid dosage forms is to improve the bioavailability of drugs and to optimize drug delivery.

    Q3. What are the different types of oral solid formulations on the basis of their timed release profiles (Instant Release/Sustained Release/Controlled or Modified Release)?

    Drug products are often classified into typical or complex formulations, complex drugs include products with complex active ingredients, complex routes of drug delivery, or complex dosage forms such as CDMO controlled release formulations.

    If we look at CDMO oral formulations and oral applications, focusing on classic and complex oral solid dosage forms (OSD), it encompasses suspensions, powders, granules, tablets, including press coated tablets and multi-layer tablets, and capsules amongst a variety of other controlled release formulations. 

     

    Oral controlled release drug delivery products are further differentiated on the basis of their timed release profiles into the following types:

    Immediate Release

    - An oral solid dosage with an instant release profile expels the active ingredient immediately after the drug product is swallowed and reaches the stomach.

    Sustained Release 

    - In sustained release there is a controlled release drug delivery of the drug product at a predetermined rate by maintaining a constant drug level for specific periods of time. 

    Controlled Release 

    - Controlled release formulations are released into the body in specified amounts over a given period of time. The controlled-release drug delivery system is designed to release the active pharmaceutical ingredient gradually over the day.

    Q4. What is the mechanism of action of controlled release drug delivery systems (DDS)?

    Looking at CDMO controlled release formulations, we now assess the development of modified-release dosage forms with controlled release drug delivery systems; for example, CDMO modified release tablets. The development of modified-release formulations is achieved via controlled drug release methods, involving both delayed and extended release systems of oral administration. These delivery mechanisms alter the timing or rate of release of active ingredients to successfully modify the expulsion of poorly water-soluble drugs in the body. 

    CMO controlled release formulations employ controlled delivery expertise in drug product development and controlled-release drug-delivery technologies, in order to develop a controlled-release tablet which adjusts API intake by expelling the desired therapeutic agents to the right part of the gastrointestinal system at the right time, for long periods in the body. 

    Controlled release drug delivery systems offer numerous advantages over traditional methods, including tailoring of drug release rates, protection of fragile drugs, and increased patient comfort and compliance. Modified oral drug delivery technology further achieves bioavailability enhancement for oral solid dosage forms.

    Q5. What are extended and delayed modified release oral dosage forms? What are their advantages and disadvantages?

    A CDMO offering controlled release formulation development and manufacturing, often concentrates on customizable drug delivery platforms for controlled release profiles, which include controlled release or modified release formulations. 

    Companies can use their annex of technology transfer CDMO services to provide modified release formulations with timed-release profiles to solve technological challenges. CDMO modified release tablets and capsules improve the bioavailability of drugs by making them more soluble and hence easier to absorb in the body.

     

    Controlled Release Formulations:

    Extended: Extended complex modified-release of oral solid dosage forms allows a reduction in dosing frequency and are designed to release the medication in a controlled manner by using Controlled Release Technologies (CRT), at a predetermined rate, duration, and location in the body to achieve and maintain optimum therapeutic blood levels of the drug. This technology makes it possible to retain a drug in the stomach for an extended period of time.

    Delayed: Whereas, development of modified-release dosage forms employing delayed release, expel the drug at a time other than promptly after administration and also creates a delayed release for specific site delivery. The delay may be time-based or based on the influence of environmental conditions such as GI, pH, enzyme, and pressure. 

     

    Advantages and disadvantages of modified, customizable oral drug release forms:

    Advantages of modified, controlled release profiles include sustained blood levels, improved solubility, reduced dosing frequency, attenuation of adverse effects, and improved patient compliance. Disadvantages include increased costs, slower onset of action, and prolonged side effects.

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    CONTROLLED DRUG DELIVERY

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    Skyepharma is a contract development and manufacturing organization (CDMO) that serves the global pharmaceutical industry by providing controlled-release expertise in drug development and oral drug delivery technologies for solid dosage forms.

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    Skyepharma Controlled Drug Delivery

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    Mission | CDMO

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    CONTROLLED & IMMEDIATE RELEASE TABLETS

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    Mission CDMO offers contract services with over seven decades of product development & manufacturing experience. It includes the development of solid oral dosage forms such as controlled & immediate-release tablets, coated tablets, uncoated tablets, etc.

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    MODIFIED RELEASE FORMULATION DEVELOPMENT

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    Douglas CDMO offers formulation development of modified release oral dosage forms. It also assists in the development of tablets, capsules, and liquid drug products.

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    CDMO FOR MODIFIED RELEASE FORMULATIONS

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    Quotient Sciences offers formulation development contract services for oral solid dosage forms (OSDs), including immediate, sustained and modified release tablets, mini-tablets, orally disintegrating tablets (ODTs), etc.

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    MODIFIED RELEASE FORMULATION DEVELOPMENT

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    Athena develops a broad range of technology platforms for oral drug delivery, with a special focus on modified-release formulations, such as immediate, delayed, sustained, extended, sublingual, and orodispersible tablets (ODTs).

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    MODIFIED RELEASE TABLET MANUFACTURING

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    Biophore is engaged in the development and manufacturing of niche drug formulations and modified-release oral solids such as tablets and capsules.

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      CONTROLLED & SUSTAINED RELEASE FORMULATIONS

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      Hankang has established technologies for the development of oral controlled and sustained release formulation including matrix sustained release, membrane sustained release, etc.

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      Prague Scientific offers formulation development of oral solids such as immediate release, modified release, delayed release tablets and capsules with multi unit delivery systems (pellets).

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      SUSTAINED & CONTROLLED RELEASE FORMULATIONS

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      One Pharma is a contract development and manufacturing organization (CDMO), which offers oral-controlled and sustained-release formulations, solid and non-sterile liquid dosage forms.

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      Ethypharm is a full-service CDMO that provides controlled & immediate release formulations. It has expertise in Flashtab, Tmask, Nanosizing, Multicaps, Transmucosal, and Orodispersible technologies.

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        CONTROLLED & MODIFIED RELEASE FORMULATIONS

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        Renejix is a contract development and manufacturing organization (CDMO) with formulation development capabilities for controlled, immediate, modified, and extended release small molecule tablets and capsules.

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        Biophore India Pharmaceuticals Pvt Ltd

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        MODIFIED RELEASE CAPSULE DEVELOPMENT

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        Biophore offers development and manufacturing of modified-release capsules and tablets.

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        Biophore Modified Release Capsule Development

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          Ascent is an end-to-end CDMO offering pharmaceutical development of immediate release tablets ranging from early phase formulation development to clinical supplies for new chemical entities, generics and life cycle extension products.

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          MICROSPHERES & ACTIVE INGREDIENTS & MATRIX MATERIALS

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          Control the release rate by using Precision Particle Fabrication to produce exact, uniform microspheres. Active ingredients and matrix materials are first combined and then processed through the Orbis nozzle to create microspheres of the desired size.

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            Ascent is an end-to-end CDMO offering pharmaceutical formulation development services for modified release tablets ranging from early phase formulation development to clinical supplies for new chemical entities, generics and life cycle extension products.

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              PROTOTYPE FORMULATION OF CONTROLLED RELEASE TABLET

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              Ropack Pharma Solutions offers pharmaceutical formulation development expertise for products at all stages. From early phase drug formulation, formulation selection & optimization, and release profile definition to late-stage formulation troubleshooting.

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                PROTOTYPE FORMULATION OF CONTROLLED RELEASE CAPSULE

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                Ropack Pharma Solutions offers pharmaceutical formulation development expertise for products at all stages. From early phase drug formulation, formulation selection & optimization, and release profile definition to late-stage formulation troubleshooting

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                  IMMEDIATE AND MODIFIED RELEASE FORMULATIONS

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                  Axxelent offers contract development for various immediate-release formulations, such as chewable & sublingual tablets and oral disintegrating tablets (ODTs) along with modified-release formulations including matrix & wax matrix tablets, DR tablets, etc.

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                  CONTROLLED RELEASE FORMULATIONS

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                  Recro’s scientists are multi-particulate controlled drug release experts and innovators. They bring extensive experience in Wurster processing, rotor powder layering and rotary granulation to optimize drug delivery and for precision coating application.

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                  Adare has unparalleled experience in the formulation development of unique oral dose forms and injectable delivery systems with expertise in taste masking and controlled release for oral and injectable dosage forms.

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                    SUSTAINED RELEASE TABLET FORMULATION & DEVELOPMENT

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                    SUSHEN Medicamentos, is a full service CDMO offering pharmaceutical formulation development services with a focus on controlled drug delivery research and product development.

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                    CONTROLLED RELEASE DRUG DELIVERY SYSTEMS

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                    Glatt can assist you in the formulation development of controlled release drug products. They offer fast drug release, modified & delayed release, targeted drug delivery and pulsatile drug release.

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                      CDMO FOR MODIFIED RELEASE FORMULATIONS

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                      Ascent is an end-to-end CDMO offering pharmaceutical formulation development services for modified release tablets ranging from early phase formulation development to clinical supplies for new chemical entities, generics and life cycle extension products.

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                        IMMEDIATE / MODIFIED / EXTENDED RELEASE TABLET / CAPSUL...

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                        PSR team has extensive experience working with the following processes and delivery methods: Immediate/Modified-Release/Controlled-Release Tablet/Capsule.

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                        Zenvision Pharma LLP

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                          EXTENDED RELEASE TABLET DEVELOPMENT

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                          Formulation Development is the core activity at Zenvision Pharma and it includes Pre-formulation studies, formulation development, analytical method development & validation, stability studies, Dossier preparation & Technology Transfer.

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                            DELAYED RELEASE TABLET DEVELOPMENT

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                            Formulation Development is the core activity at Zenvision Pharma and it includes Pre-formulation studies, formulation development, analytical method development & validation, stability studies, Dossier preparation & Technology Transfer.

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                            PharmaVize NV

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                              MODIFIED-RELEASE FORMULATIONS

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                              Pharmavize can manufacture various oral dosage forms including CDMO modified release tablets.

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                              Chanelle Medical

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                              FORMULATION DEVELOPMENT FOR SLOW RELEASE FORMULATIONS

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                              Chanelle Medical has thrived on the strength of our scientific expertise and development programmes. These drug products are developed using our in-house expert scientists and with the assistance from Chanelle’s development laboratory in Amman, Jordan.

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                              ORIT LABS LLC

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                              CONTROLLED RELEASE TABLETS DEVELOPMENT

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                              Orit Laboratories specializes in pharmaceutical contract manufacturing of generic oral pharmaceutical development. Specifically, our focus is in analytical development services and formulation development of generic oral dosage forms for the US market.

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                              Recipharm AB

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                              MODIFIED RELEASE FORMULATION DEVELOPMENT

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                              Recipharm has extensive experience in the development of modified release dosage forms. They have the ability to develop modified release tablets with a robust release rate from small-scale all the way to bulk manufacturing capabilities.

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                              Aizant Drug Research Solutions Pvt. Ltd.

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                              CONTROLLED RELEASE TABLETS DEVELOPMENT

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                              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.

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                              Zenvision Pharma LLP

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                                MODIFIED RELEASE DRUG DELIVERY SYSTEMS

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                                Formulation Development is the core activity at Zenvision Pharma and it includes Pre-formulation studies, formulation development, analytical method development & validation, stability studies, Dossier preparation & Technology Transfer.

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                                Bioplus Life Sciences

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                                EXTENDED RELEASE FORMULATION DEVELOPMENT

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                                BioPlus Life Sciences develops a variety of tablet dosage forms, including extended-release, conventional, chewable, dispersible, orodispersible, enteric-coated, etc.

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                                Mithra CDMO

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                                PLURAL POLYMER TECHNOLOGY

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                                Mithra has a strong heritage in Polymer Technology for long acting drug formulation & development. They have experience in developing multiple drug delivery strategies for drug / device combination products gained by successful preliminary development.

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                                Sai Life Sciences Limited

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                                IMMEDIATE & MODIFIED RELEASE TABLETS

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                                Sai Life Sciences have vast & rich expertise of working across multiple technologies with increasing complexity to develop variety of dosage forms such as immediate release/modified release tablets, oral disintegrating tablets & conventional tablets.

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                                Catalent Pharma Solutions

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                                IMMEDIATE & SUSTAINED RELEASE FORMULATIONS

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                                Catalent offers innovative, advanced immediate-release & modified-release formulations such as tablets including osmotic tablets, bi-layer tablets, traditional tablets and capsules including IR powder in capsules, beads for CR, and tablets in capsules.

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                                Eurofins CDMO

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                                IMMEDIATE & CONTROLLED RELEASE DOSAGE FORMS

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                                Eurofins CMDO offers a wide range of drug product development and manufacturing technologies for immediate and controlled release with liquid, solid and semi-solid dosage forms for oral, nasal, buccal and topical delivery.

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                                UPM Pharmaceuticals

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                                IMMEDIATE RELEASE SOLID ORAL DOSAGE FORMS

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                                UPM has extensive experience and oral drug delivery expertise in the formulation development of solid oral dosage forms, including immediate and controlled release formulations (tablet/capsule).

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                                Torrent Pharmaceuticals Limited

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                                SUSTAINED RELEASE TABLET DEVELOPMENT

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                                Torrent Pharma's state-of-the art R & D Centre has one of the most advanced infrastructure for both basic and applied research offering sustained release tablets and delayed release tablets.

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                                Aupa Biotech

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                                  CONTROLLED & SUSTAINED RELEASE TABLETS

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                                  Aupa Biotech is committed to providing a full range of contract development and manufacturing services for oral solid dosage forms such as controlled-release, slow-release, and sustained-release tablets along with orally disintegrating tablets (ODTs).

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                                  Avaca Pharma

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                                    DEVELOPMENT OF MODIFIED RELEASE DOSAGE FORMS

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                                    We perform formulation assessment, early stage proof of concept, formulation selection, design of experiments, pre formulation, release profile determination, formulation strategy, process development, optimization and technology development.

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                                    GALENIX INNOVATIONS

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                                      MODIFIDED RELEASE TABLET DEVELOPMENT

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                                      All kinds of dosage forms are developed at Galenix, from the most simple to the most sophisticated one. Patented Drug Delivery Systems developed by Galenix may also modify the drug product’s features in order to respond to special requirements.

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                                      GALENIX INNOVATIONS

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                                        SUSTAINED RELEASE TABLET DEVELOPMENT

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                                        All kinds of dosage forms are developed at Galenix, from the most simple to the most sophisticated one. Patented Drug Delivery Systems developed by Galenix may also modify the drug product’s features in order to respond to special requirements.

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                                        Avaca Pharma

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                                          DEVELOPMENT OF GASTRO-RETENTIVE SYSTEMS

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                                          We perform formulation assessment, early stage proof of concept, formulation selection, design of experiments, pre formulation, release profile determination, formulation strategy, process development, optimization and technology development.

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                                          Biolink LifeSciences

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                                            IMMEDIATE / MODIFIED RELEASE FORMULATIONS

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                                            Biolink Life Sciences provides immediate release solid dosage prototype development services for tablets, capsules, powders, and multi-particulate and modified release prototype development services for tablets and/or multi-particulates beads.

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                                            Lamda Laboratories

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                                              DEVELOPMENT OF MODIFIED RELEASE DOSAGE FORMS

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                                              Our key area of expertise are Immediate/Modified Rrelease -Tablets/ Capsules/Solutions/Suspensions/ Powders; Topical Dosage Forms-Creams, Ointments, Cutaneous solutions; Sterile Dosage Forms-Injectables, Nasal preparations, Ophthalmic preparations.

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                                              GALENIX INNOVATIONS

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                                                MULTILAYER TABLET, COATED TABLET DEVELOPMENT

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                                                All kinds of dosage forms are developed at Galenix, from the most simple to the most sophisticated one. Patented Drug Delivery Systems developed by Galenix may also modify the drug product’s features in order to respond to special requirements.

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                                                Custom Pharma Services

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                                                  FORMULATION DEVELOPMENT SERVICES OF MODIFIED RELEASE FO...

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                                                  Custom’s expert chemists, scientists and process engineers — many with 35 years of experience in the pharmaceutical industry — offer an extensive range of clinical and product development expertise, including significant preformulation and formulation exp

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                                                  Ardena

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                                                    MODIFIED RELEASE FORMULATION DEVELOPMENT

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                                                    Ardena, having formulation development expertise, also offers manufacture capabilities for the following dosage forms such as modified release pellets & microspheres, spray dried powders, powder blends for reconstitution, over-encapsulated products, etc.

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                                                    Cambrex Corporation

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                                                    CONTROLLED / IMMEDIATE / MODIFIED RELEASE

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                                                    Cambrex’s drug product manufacturing and packaging capabilities cover a wide range of specialist dosage forms, including controlled substances, sterile and non-sterile forms for pediatric and fixed dose combination products

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                                                    Cyndea Pharma S.L

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                                                      DELAYED RELEASE TABLET DEVELOPMENT

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                                                      Development and manufacturing of women healthcare products and niche type products for third party partners (B2B), covering world wide markets.

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                                                      Cyndea Pharma S.L

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                                                        FILM COATED TABLET DEVELOPMENT

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                                                        Development and manufacturing of women healthcare products and niche type products for third party partners (B2B), covering world wide markets.

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                                                        Cyndea Pharma S.L

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                                                          MULTI-LAYER TABLET DEVELOPMENT

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                                                          Development and manufacturing of women healthcare products and niche type products for third party partners (B2B), covering world wide markets.

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                                                          Aragen Life Sciences

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                                                          DEVELOPMENT OF DELAYED RELEASE TABLET

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

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                                                          Aragen Life Sciences

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                                                          DEVELOPMENT OF SUSTAINED RELEASE TABLET

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

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                                                          Aragen Life Sciences

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                                                          DEVELOPMENT OF BI-LAYERED TABLET

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

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                                                          Aragen Life Sciences

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                                                          DEVELOPMENT OF CAPSULES FILLED WITH PELLETS (ER & SR)

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

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                                                          Aragen Life Sciences

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                                                          DEVELOPMENT OF MODIFIED RELEASE CAPSULES

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                                                          GVK BIO adopts a comprehensive, time-bound strategy in developing stable products that are efficient in all quality aspects. GVK BIO has expertise to develop modified release - beads or mini tablets in capsules.

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                                                          Pharma Service: API & Drug Product Development

                                                          Category: Formulation Development

                                                          Sub Category: Controlled / Immediate / Modified Release
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                                                          IMMEDIATE RELEASE TABLET

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                                                          Servier CDMO has the capabilities to deliver your project from development through to the manufacture of large commercial batch sizes of tablets, capsules or powders. Servier has 60 years of experience with a proven track record of quality and regulatory approval to ensure reliability for your

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                                                          Pharma Service: API & Drug Product Development

                                                          Category: Formulation Development

                                                          Sub Category: Controlled / Immediate / Modified Release
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                                                          CONTROLLED & MODIFIED RELEASE TABLET

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                                                          URL Supplier Web Content
                                                          LM Capability #LearnMore

                                                          - Service Details

                                                          Servier CDMO has the capabilities to deliver your project from development through to the manufacture of large commercial batch sizes of tablets, capsules or powders. Servier has 60 years of experience with a proven track record of quality and regulatory approval to ensure reliability for your

                                                          - Directory Listing

                                                          Pharma Service: API & Drug Product Development

                                                          Category: Formulation Development

                                                          Sub Category: Controlled / Immediate / Modified Release
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                                                          your Marketing & Sales content

                                                          Servier

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                                                          • FDA
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                                                          Flag France
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                                                          SINGLE, BI-LAYER & TRI-LAYER TABLET

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                                                          URL Supplier Web Content
                                                          LM Capability #LearnMore

                                                          - Service Details

                                                          Servier CDMO has the capabilities to deliver your project from development through to the manufacture of large commercial batch sizes of tablets, capsules or powders. Servier has 60 years of experience with a proven track record of quality and regulatory approval to ensure reliability for your

                                                          - Directory Listing

                                                          Pharma Service: API & Drug Product Development

                                                          Category: Formulation Development

                                                          Sub Category: Controlled / Immediate / Modified Release
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                                                          US
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