Hot-Melt Co-extrusion Technology as a Manufacturing Platform for Anti-hypertensive Fixed-Dose Combinations

Gareth C. Gilvary, Ammar Almajaan, Shu Li, Zoe Senta Loys, Yiwei Tian, Jeremiah Kelleher, Atif Madi, Anne Marie Healy, David Jones, Gavin Andrews

Research output: Contribution to conferencePoster

Abstract

Hypertension (HYP) accounts for 9.4 million deaths worldwide annually and requires the long-term use of medicines as part of complex drug regimens. While marketed anti-hypertensive medications containing active pharmaceutical ingredients (APIs) have been clinically proven to be effective in the treatment of HYP, their full benefits are often not realised due to poor medication adherence . There are several factors which exist for poor medication adherence including those related to the patient i.e. increased age or a lack of understanding of their disease state. It is generally accepted that adherence becomes poorer as the number of medicines prescribed is increased. This is a particular problem in the treatment of HYP, as it generally requires multiple drugs for a positive clinical outcome. Therefore, the industry has attempted to overcome this burden by combining various APIs into a single pill, which are commonly referred to as fixed-dose combinations (FDCs). Recently, hot-melt (co)-extrusion (HMCE) has received considerable attention from the pharmaceutical industry for the production of FDCs, due to its ability in designing multi-layered FDCs in a single processing step. Furthermore, HMCE products are capable of independently modulating the release of the incorporated APIs. This investigation utilises HMCE to manufacture a multi-layered FDC containing hydrochlorothiazide (HCTZ) and losartan potassium (LK). These APIs are recommended to be used in combination once-a-day for the treatment of HYP, as they have been shown to be well tolerated and more efficacious in lowering blood pressure (BP) than monotherapy.
Original languageEnglish
Publication statusPublished - 07 Nov 2018
EventAAPS PharmSci360 - Walter E. Washington Convention Center, Washington, DC, United States
Duration: 04 Nov 201807 Nov 2018
https://www.aaps.org/pharmsci/annual-meeting

Conference

ConferenceAAPS PharmSci360
CountryUnited States
CityWashington, DC
Period04/11/201807/11/2018
Internet address

Fingerprint

Antihypertensive Agents
Technology
Pharmaceutical Preparations
Hypertension
Medication Adherence
Aptitude
Drug Industry
Industry
Therapeutics
Blood Pressure

Cite this

Gilvary, G. C., Almajaan, A., Li, S., Senta Loys, Z., Tian, Y., Kelleher, J., ... Andrews, G. (2018). Hot-Melt Co-extrusion Technology as a Manufacturing Platform for Anti-hypertensive Fixed-Dose Combinations. Poster session presented at AAPS PharmSci360, Washington, DC, United States.
Gilvary, Gareth C. ; Almajaan, Ammar ; Li, Shu ; Senta Loys, Zoe ; Tian, Yiwei ; Kelleher, Jeremiah ; Madi, Atif ; Healy, Anne Marie ; Jones, David ; Andrews, Gavin. / Hot-Melt Co-extrusion Technology as a Manufacturing Platform for Anti-hypertensive Fixed-Dose Combinations. Poster session presented at AAPS PharmSci360, Washington, DC, United States.
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abstract = "Hypertension (HYP) accounts for 9.4 million deaths worldwide annually and requires the long-term use of medicines as part of complex drug regimens. While marketed anti-hypertensive medications containing active pharmaceutical ingredients (APIs) have been clinically proven to be effective in the treatment of HYP, their full benefits are often not realised due to poor medication adherence . There are several factors which exist for poor medication adherence including those related to the patient i.e. increased age or a lack of understanding of their disease state. It is generally accepted that adherence becomes poorer as the number of medicines prescribed is increased. This is a particular problem in the treatment of HYP, as it generally requires multiple drugs for a positive clinical outcome. Therefore, the industry has attempted to overcome this burden by combining various APIs into a single pill, which are commonly referred to as fixed-dose combinations (FDCs). Recently, hot-melt (co)-extrusion (HMCE) has received considerable attention from the pharmaceutical industry for the production of FDCs, due to its ability in designing multi-layered FDCs in a single processing step. Furthermore, HMCE products are capable of independently modulating the release of the incorporated APIs. This investigation utilises HMCE to manufacture a multi-layered FDC containing hydrochlorothiazide (HCTZ) and losartan potassium (LK). These APIs are recommended to be used in combination once-a-day for the treatment of HYP, as they have been shown to be well tolerated and more efficacious in lowering blood pressure (BP) than monotherapy.",
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Gilvary, GC, Almajaan, A, Li, S, Senta Loys, Z, Tian, Y, Kelleher, J, Madi, A, Healy, AM, Jones, D & Andrews, G 2018, 'Hot-Melt Co-extrusion Technology as a Manufacturing Platform for Anti-hypertensive Fixed-Dose Combinations', AAPS PharmSci360, Washington, DC, United States, 04/11/2018 - 07/11/2018.

Hot-Melt Co-extrusion Technology as a Manufacturing Platform for Anti-hypertensive Fixed-Dose Combinations. / Gilvary, Gareth C.; Almajaan, Ammar; Li, Shu; Senta Loys, Zoe; Tian, Yiwei; Kelleher, Jeremiah; Madi, Atif; Healy, Anne Marie; Jones, David; Andrews, Gavin.

2018. Poster session presented at AAPS PharmSci360, Washington, DC, United States.

Research output: Contribution to conferencePoster

TY - CONF

T1 - Hot-Melt Co-extrusion Technology as a Manufacturing Platform for Anti-hypertensive Fixed-Dose Combinations

AU - Gilvary, Gareth C.

AU - Almajaan, Ammar

AU - Li, Shu

AU - Senta Loys, Zoe

AU - Tian, Yiwei

AU - Kelleher, Jeremiah

AU - Madi, Atif

AU - Healy, Anne Marie

AU - Jones, David

AU - Andrews, Gavin

PY - 2018/11/7

Y1 - 2018/11/7

N2 - Hypertension (HYP) accounts for 9.4 million deaths worldwide annually and requires the long-term use of medicines as part of complex drug regimens. While marketed anti-hypertensive medications containing active pharmaceutical ingredients (APIs) have been clinically proven to be effective in the treatment of HYP, their full benefits are often not realised due to poor medication adherence . There are several factors which exist for poor medication adherence including those related to the patient i.e. increased age or a lack of understanding of their disease state. It is generally accepted that adherence becomes poorer as the number of medicines prescribed is increased. This is a particular problem in the treatment of HYP, as it generally requires multiple drugs for a positive clinical outcome. Therefore, the industry has attempted to overcome this burden by combining various APIs into a single pill, which are commonly referred to as fixed-dose combinations (FDCs). Recently, hot-melt (co)-extrusion (HMCE) has received considerable attention from the pharmaceutical industry for the production of FDCs, due to its ability in designing multi-layered FDCs in a single processing step. Furthermore, HMCE products are capable of independently modulating the release of the incorporated APIs. This investigation utilises HMCE to manufacture a multi-layered FDC containing hydrochlorothiazide (HCTZ) and losartan potassium (LK). These APIs are recommended to be used in combination once-a-day for the treatment of HYP, as they have been shown to be well tolerated and more efficacious in lowering blood pressure (BP) than monotherapy.

AB - Hypertension (HYP) accounts for 9.4 million deaths worldwide annually and requires the long-term use of medicines as part of complex drug regimens. While marketed anti-hypertensive medications containing active pharmaceutical ingredients (APIs) have been clinically proven to be effective in the treatment of HYP, their full benefits are often not realised due to poor medication adherence . There are several factors which exist for poor medication adherence including those related to the patient i.e. increased age or a lack of understanding of their disease state. It is generally accepted that adherence becomes poorer as the number of medicines prescribed is increased. This is a particular problem in the treatment of HYP, as it generally requires multiple drugs for a positive clinical outcome. Therefore, the industry has attempted to overcome this burden by combining various APIs into a single pill, which are commonly referred to as fixed-dose combinations (FDCs). Recently, hot-melt (co)-extrusion (HMCE) has received considerable attention from the pharmaceutical industry for the production of FDCs, due to its ability in designing multi-layered FDCs in a single processing step. Furthermore, HMCE products are capable of independently modulating the release of the incorporated APIs. This investigation utilises HMCE to manufacture a multi-layered FDC containing hydrochlorothiazide (HCTZ) and losartan potassium (LK). These APIs are recommended to be used in combination once-a-day for the treatment of HYP, as they have been shown to be well tolerated and more efficacious in lowering blood pressure (BP) than monotherapy.

M3 - Poster

ER -

Gilvary GC, Almajaan A, Li S, Senta Loys Z, Tian Y, Kelleher J et al. Hot-Melt Co-extrusion Technology as a Manufacturing Platform for Anti-hypertensive Fixed-Dose Combinations. 2018. Poster session presented at AAPS PharmSci360, Washington, DC, United States.