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Testosterone Replacement, Low T, HCG, & Beyond
Clomid for PCT, fertility or low T
EXTENDED-RELEASE FORMULATIONS OF HUMAN CHORIONIC GONADOTROPIN (HCG)
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<blockquote data-quote="madman" data-source="post: 238275" data-attributes="member: 13851"><p>[ATTACH=full]26681[/ATTACH]</p><p></p><p></p><p><strong><em>SynBiosys is an advanced biodegradable polymeric drug delivery system for the sustained release of small molecules and biologics. SynBiosys offers unsurpassed control over drug release kinetics and assures preservation of the bioactivity of sensitive therapeutic agents, thereby improving pharmacotherapeutic efficacy and reducing side effects. The platform is perfectly suited for the development of long-acting injectable dosage forms for the treatment of chronic and site-specific diseases. SynBiosys also offers excellent opportunities to upgrade current products and extend patent protection for effective life cycle management.</em></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Unique polymer architecture</strong></p><p></p><p><em><strong>The SynBiosys polymer platform comprises poly(ether ester) multi-block copolymers composed of building blocks based on different amounts and combinations of well-known monomers such as DL-lactide, glycolide, ε-caprolactone, p-dioxanone, and polyethylene glycol (Fig. 1)</strong>. A major advantage of this system is the tunability of the chemical composition, creating a diverse family of customized polymers with tightly controlled properties (e.g. glass transition temperature, swelling degree, erosion rate).</em></p><p></p><p></p><p><strong>Figure1 Example of a SynBiosys multi-block co-polymer.</strong></p><p>[ATTACH=full]26682[/ATTACH]</p><p></p><p><strong>SynBiosys polymers can be processed into various dosage forms, thereby allowing them to be used in a wide range of applications.</strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Dosage forms</strong><em> </em></p><p><em></em></p><p><em><strong>SynBiosys polymers allow the development of<u> long-acting-injectable (LAI) dosage forms in the form of microsphere suspensions</u>, hot-melt extruded solid implants, and in situ-forming implants (Fig. 2) for basically any class of drug molecule. </strong>InnoCore has the disposal of advanced and proprietary manufacturing technologies, including a membrane emulsification solvent extraction-based microencapsulation process and low-temperature hot melt (co)extrusion for implant production.</em></p><p></p><p></p><p><strong>Figure 2 Examples of SynBiosys-based dosage: microspheres, extruded implants, and in situ forming implants</strong></p><p><strong>[ATTACH=full]26683[/ATTACH]</strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Unsurpassed ability to control the release kinetics </strong></p><p></p><p><em>Lipophilic small molecules, peptides, and biologics have been successfully formulated into SynBiosys-based LAI dosage forms with precisely controlled release kinetics. Drug release from hydrophilic SynBiosys occurs through a combined diffusion/degradation mechanism. <strong>Via a selection and optimalization of polymer composition, depot formulations with customized release kinetics (linear, pulsed, delayed-release) and release duration varying from a week to åover a year can be developed (Fig.3).</strong></em></p><p></p><p></p><p><strong><u>Figure 3</u> SynBiosys polymers allow the development of LAI dosage forms with precisely controlled release kinetics of small molecules and biologics.</strong></p><p><strong></strong></p><p><strong>Left:</strong><em> <strong>Cumulative in vitro release of <u>human chorionic gonadotropin from SynBiosys microspheres</u>.</strong></em></p><p></p><p><strong>Right:</strong><em> <strong>In vivo pharmacokinetics of a SynBiosys-based hot-melt extruded levonorgestrel implant.</strong></em></p><p><em><strong></strong></em></p><p><em><strong>[ATTACH=full]26684[/ATTACH]</strong></em></p><p></p><p><strong>SynBiosys is designed to offer optimal control over the release kinetics and bioactivity of therapeutic agents, improving pharmacotherapeutic efficacy and reducing side effects.</strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Hydrophilic polymers preserve the integrity and activity of sensitive encapsulated compounds</strong></p><p></p><p><em>One of the most critical aspects in the development of long-acting injectables for biologics is the preservation of the integrity and activity of the encapsulated compound. Due to its hydrophilic nature, SynBiosys forms a protein-friendly hydrogel-like matrix in which acidic degradation products do not accumulate. <strong>Avoiding the formation of an acidic microenvironment (as occurs in PLGA-based LAI dosage forms) is crucial to assure the stability of pH-sensitive molecules, especially biologics such as recombinant proteins and monoclonal antibodies (mAb). The ability of SynBiosys to preserve the integrity and biological activity during product manufacturing and during release from the dosage form has been demonstrated both in vitro (Fig. 4) and in vivo (Fig. 5) for various biologics</strong></em></p><p></p><p></p><p><strong><u>Figure 4</u> Hydrophilic polymers are compatible with large biologics, such as monoclonal antibodies (mAbs).</strong></p><p><strong></strong></p><p><strong>Left:</strong> <strong><em>Using different SynBiosys® polymers the release of mAb’s can be controlled for up to several months.</em></strong></p><p><strong></strong></p><p><strong>Right: </strong><em><strong>Antibodies remain structurally intact and properly folded during microencapsulation and throughout long-term release from the microspheres.</strong></em></p><p></p><p>[ATTACH=full]26685[/ATTACH]</p><p></p><p></p><p></p><p></p><p><strong><u>Figure 5</u> SynBiosys is designed to protect sensitive biologics and has been shown to release biologics structurally intact and bioactive, both in vitro and in vivo. For more information see our Androsphere™ Application Note</strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Left: </strong><em><strong>Structural integrity (measured using SEC-UPLC) and bioactivity (measured using cell-based assay) of <u>human chorionic gonadotropin (hCG) released from hCG extended-release microspheres</u>.</strong></em></p><p></p><p><strong>Right:</strong> <strong><em><u>In vivo PK/PD of hCG extended-release microspheres following single subcutaneous injection</u>. The biological activity of in vivo released hCG was confirmed by increased testosterone production as a result of elevated hCG plasma levels.</em></strong></p><p></p><p>[ATTACH=full]26686[/ATTACH]</p><p></p><p></p><p></p><p></p><p><strong>SynBiosys polymers degrade gradually and completely </strong></p><p></p><p><em>Under physiological conditions, SynBiosys polymers degrade via hydrolysis into non-toxic and biologically safe degradation products that are metabolized and/or excreted through the urinary pathway. <strong>After completion of drug release, polymers degrade gradually and completely, thereby avoiding polymer accumulation upon repeated administration or dose-dumping of acidic degradation products, which minimizes the chance of long-term foreign body reaction</strong></em><strong><em>s.</em></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Safe and clinically validated platform </strong></p><p></p><p><em>In addition to extensive in vitro toxicity testing and assessment of in vivo biocompatibility in many different animal models (rats, rabbits, pigs, horses, monkeys), <strong>SynBiosys has been safely used in thousands of patients. An extensive biological safety report is available. Regulatory approvals have been granted for SynBiosysbased cardiovascular drug-eluting stents (COMBO Plus Dual Therapy DES, OrbusNeich®) in Europe, Japan, and China since 2013.</strong></em></p><p></p><p></p><p></p><p></p><p><strong>Manufacturing of SynBiosys® dosage forms </strong></p><p><strong></strong></p><p><strong><em>InnoCore offers fully integrated pharmaceutical development services for microspheres, hot-melt extruded implants, and in situ forming implants. <u>Development is performed in InnoCore’s research facilities in Groningen, the Netherlands, with cleanrooms for small-scale manufacturing of drug products suitable for pre-clinical evaluation and GMP-certified analytical labs for quality control</u>. Through a network of qualified CMOs, InnoCore also offers GMP manufacturing of clinical supplies of SynBiosys-based dosage forms. polymers are manufactured under a supply agreement at kilogram scale under GMP.</em></strong></p></blockquote><p></p>
[QUOTE="madman, post: 238275, member: 13851"] [ATTACH type="full" alt="Screenshot (18413).png"]26681[/ATTACH] [B][I]SynBiosys is an advanced biodegradable polymeric drug delivery system for the sustained release of small molecules and biologics. SynBiosys offers unsurpassed control over drug release kinetics and assures preservation of the bioactivity of sensitive therapeutic agents, thereby improving pharmacotherapeutic efficacy and reducing side effects. The platform is perfectly suited for the development of long-acting injectable dosage forms for the treatment of chronic and site-specific diseases. SynBiosys also offers excellent opportunities to upgrade current products and extend patent protection for effective life cycle management.[/I] Unique polymer architecture[/B] [I][B]The SynBiosys polymer platform comprises poly(ether ester) multi-block copolymers composed of building blocks based on different amounts and combinations of well-known monomers such as DL-lactide, glycolide, ε-caprolactone, p-dioxanone, and polyethylene glycol (Fig. 1)[/B]. A major advantage of this system is the tunability of the chemical composition, creating a diverse family of customized polymers with tightly controlled properties (e.g. glass transition temperature, swelling degree, erosion rate).[/I] [B]Figure1 Example of a SynBiosys multi-block co-polymer.[/B] [ATTACH type="full" alt="Screenshot (18414).png"]26682[/ATTACH] [B]SynBiosys polymers can be processed into various dosage forms, thereby allowing them to be used in a wide range of applications. Dosage forms[/B][I] [B]SynBiosys polymers allow the development of[U] long-acting-injectable (LAI) dosage forms in the form of microsphere suspensions[/U], hot-melt extruded solid implants, and in situ-forming implants (Fig. 2) for basically any class of drug molecule. [/B]InnoCore has the disposal of advanced and proprietary manufacturing technologies, including a membrane emulsification solvent extraction-based microencapsulation process and low-temperature hot melt (co)extrusion for implant production.[/I] [B]Figure 2 Examples of SynBiosys-based dosage: microspheres, extruded implants, and in situ forming implants [ATTACH type="full" alt="Screenshot (18415).png"]26683[/ATTACH] Unsurpassed ability to control the release kinetics [/B] [I]Lipophilic small molecules, peptides, and biologics have been successfully formulated into SynBiosys-based LAI dosage forms with precisely controlled release kinetics. Drug release from hydrophilic SynBiosys occurs through a combined diffusion/degradation mechanism. [B]Via a selection and optimalization of polymer composition, depot formulations with customized release kinetics (linear, pulsed, delayed-release) and release duration varying from a week to åover a year can be developed (Fig.3).[/B][/I] [B][U]Figure 3[/U] SynBiosys polymers allow the development of LAI dosage forms with precisely controlled release kinetics of small molecules and biologics. Left:[/B][I] [B]Cumulative in vitro release of [U]human chorionic gonadotropin from SynBiosys microspheres[/U].[/B][/I] [B]Right:[/B][I] [B]In vivo pharmacokinetics of a SynBiosys-based hot-melt extruded levonorgestrel implant. [ATTACH type="full" alt="Screenshot (18416).png"]26684[/ATTACH][/B][/I] [B]SynBiosys is designed to offer optimal control over the release kinetics and bioactivity of therapeutic agents, improving pharmacotherapeutic efficacy and reducing side effects. Hydrophilic polymers preserve the integrity and activity of sensitive encapsulated compounds[/B] [I]One of the most critical aspects in the development of long-acting injectables for biologics is the preservation of the integrity and activity of the encapsulated compound. Due to its hydrophilic nature, SynBiosys forms a protein-friendly hydrogel-like matrix in which acidic degradation products do not accumulate. [B]Avoiding the formation of an acidic microenvironment (as occurs in PLGA-based LAI dosage forms) is crucial to assure the stability of pH-sensitive molecules, especially biologics such as recombinant proteins and monoclonal antibodies (mAb). The ability of SynBiosys to preserve the integrity and biological activity during product manufacturing and during release from the dosage form has been demonstrated both in vitro (Fig. 4) and in vivo (Fig. 5) for various biologics[/B][/I] [B][U]Figure 4[/U] Hydrophilic polymers are compatible with large biologics, such as monoclonal antibodies (mAbs). Left:[/B] [B][I]Using different SynBiosys® polymers the release of mAb’s can be controlled for up to several months.[/I] Right: [/B][I][B]Antibodies remain structurally intact and properly folded during microencapsulation and throughout long-term release from the microspheres.[/B][/I] [ATTACH type="full" alt="Screenshot (18417).png"]26685[/ATTACH] [B][U]Figure 5[/U] SynBiosys is designed to protect sensitive biologics and has been shown to release biologics structurally intact and bioactive, both in vitro and in vivo. For more information see our Androsphere™ Application Note Left: [/B][I][B]Structural integrity (measured using SEC-UPLC) and bioactivity (measured using cell-based assay) of [U]human chorionic gonadotropin (hCG) released from hCG extended-release microspheres[/U].[/B][/I] [B]Right:[/B] [B][I][U]In vivo PK/PD of hCG extended-release microspheres following single subcutaneous injection[/U]. The biological activity of in vivo released hCG was confirmed by increased testosterone production as a result of elevated hCG plasma levels.[/I][/B] [ATTACH type="full" alt="Screenshot (18418).png"]26686[/ATTACH] [B]SynBiosys polymers degrade gradually and completely [/B] [I]Under physiological conditions, SynBiosys polymers degrade via hydrolysis into non-toxic and biologically safe degradation products that are metabolized and/or excreted through the urinary pathway. [B]After completion of drug release, polymers degrade gradually and completely, thereby avoiding polymer accumulation upon repeated administration or dose-dumping of acidic degradation products, which minimizes the chance of long-term foreign body reaction[/B][/I][B][I]s.[/I] Safe and clinically validated platform [/B] [I]In addition to extensive in vitro toxicity testing and assessment of in vivo biocompatibility in many different animal models (rats, rabbits, pigs, horses, monkeys), [B]SynBiosys has been safely used in thousands of patients. An extensive biological safety report is available. Regulatory approvals have been granted for SynBiosysbased cardiovascular drug-eluting stents (COMBO Plus Dual Therapy DES, OrbusNeich®) in Europe, Japan, and China since 2013.[/B][/I] [B]Manufacturing of SynBiosys® dosage forms [I]InnoCore offers fully integrated pharmaceutical development services for microspheres, hot-melt extruded implants, and in situ forming implants. [U]Development is performed in InnoCore’s research facilities in Groningen, the Netherlands, with cleanrooms for small-scale manufacturing of drug products suitable for pre-clinical evaluation and GMP-certified analytical labs for quality control[/U]. Through a network of qualified CMOs, InnoCore also offers GMP manufacturing of clinical supplies of SynBiosys-based dosage forms. polymers are manufactured under a supply agreement at kilogram scale under GMP.[/I][/B] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Clomid for PCT, fertility or low T
EXTENDED-RELEASE FORMULATIONS OF HUMAN CHORIONIC GONADOTROPIN (HCG)
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