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Introducing Klucel™ hydroxypropylcellulose (HPC) in Solid Oral Dosage Forms

Klucel™ hydroxypropylcellulose (HPC) is a water-soluble cellulose ether with a remarkable combination of properties. It combines organic solvent solubility, thermoplastic, and surface activity with the aqueous thickening and stabilizing properties characteristic of other water-soluble cellulose polymers. Additionally, Klucel™ HPC can precipitate from aqueous solutions at 40°C-45°C, and this precipitation is completely reversible. Klucel™ HPC films are non-tacky at high humidity and flexible without the use of plasticizers.

DKSH and our partner, Ashland Inc. would like to introduce Klucel™ HPC as a binder in solid oral dosage forms. It can be used for immediate and controlled release formulations, as well as hot melt extrusion. This versatile excipient is available in fine particle size grades, allowing for a more homogeneous distribution and a larger surface area for interaction with other excipients. These characteristics make Klucel™ HPC an excellent choice for various pharmaceutical and nutraceutical usages worldwide, including tablet binding, modified release matrix formation, hot melt extrusion for controlled release, continuous granulation, and film coatings.

 

 

  1. Tablet binding

Klucel™ HPC is without a doubt a preferred binder due to its superior thermoplastic and mechanical properties.  As a dry binder, Klucel™ HPC can be added in powder form and does not require any liquid for binding. It is a versatile binder that can bind with both immediate and controlled release. This gives researchers more flexibility when developing dose formulations with various release profiles.

 

  1. Modified-release Matrix former

In modified-release matrix formulations, Klucel™ HPC plays a critical role in controlling the release of the active pharmaceutical ingredient (API) by forming a hydrophilic matrix that slows down the release of the API from the tablet. When the polymer encounters water, it expands, forming a gel layer that modulates the API's diffusion out of the tablet.

The amount of Klucel™ HPC used in a formulation can be adjusted to achieve different API release rates. Lower levels of Klucel™ HPC result in faster release rates, while higher levels result in slower release rates.

Overall, Klucel™ HPC is an essential component of modified-release matrix formulations because it allows for consistent, controlled release of the API over a long period of time, providing therapeutic benefits to patients.

 

  1. Hot-melt extrusion (HME) for controlled-release applications

Klucel™ HPC is also widely used in hot-melt extrusion (HME) formulations for controlled-release applications. It is pliable and easy to extrude due to its low glass transition temperature. According to several internal experiments, hot-melt extrusion (HME) can produce tablets with higher compatibility and lower friability than equivalent formulations produced by conventional processes, resulting in smaller tablets for high-dose drugs and combination products.

 

  1. Continuous granulation

Klucel™ HPC can be used for continuous granulation to produce tablets that are both stronger and fast-dissolving. This allows for cost-effective manufacturing with smaller equipment and modest capital investment, making manufacturing more scalable.

 

  1. Film coating

Klucel™ HPC can be used alone or in combination with other polymers to achieve the desired properties of the film coating. The amount of Klucel™ HPC used in the formulation can be adjusted to achieve the desired release profile of the API. Film coatings based on Klucel™ HPC have several shared characteristics, including:

  • Outstanding film flexibility
  • Good film adhesion
  • Relatively low moisture vapor transmission rates
  • Low glass transition temperatures
  • Greater degrees of tackiness
  • Greater resistance to microbial growth

To summarize, Klucel™ hydroxypropylcellulose (HPC) is a highly preferred binder. Depending on your company's needs, using Klucel HPC can result in effective pharmaceutical and medical outcomes.

 

About Ashland

Ashland Inc. is a global company that specializes in producing a variety of specialty chemicals used in a range of industries, such as nutraceuticals, personal care, and pharmaceuticals. DKSH’s Business Unit Performance Materials is a premier distributor of specialized chemicals and ingredients, and also offers market expansion services. Our collaboration can fulfill your company’s needs and provide effective business solutions.

If you're interested in Klucel™ HPC or other pharmaceutical excipients such as from cellulose derivatives, polyvinyl chemistry, cyclodextrin derivatives and bioresorbable polymers for long acting injectables; please don't hesitate to contact us. We provide a wide range of business services, including product development, sourcing, marketing, sales, distribution, and after-sales support. DKSH has a vast network and expertise to assist you in expanding your market and growing your business.

 

Biography

Dr. Sachin S. Salunkhe is having more than 9 years of industrial experience in Formulation research and Business development with 4 years exclusively research experience in development of lipid based formulations for drug delivery to brain. He has been working as Manager, Technical Business development in DKSH India Pvt Ltd for across INDIA and some extent to South Asia. He is representing techno-commercial facets with all its essentials and nitty-gritty in domain of Pharma excipients, Nutraceuticals, Biological solutions etc. Currently, successfully completed Six Sigma Green Belt certification course with leveraging coverage for Operation Excellence and Effective leadership principles in corporate affairs. He has expertise in the area of formulation development of complex generics involving injectable products; solid oral and extending to biopharmaceuticals, protein and peptide based drug delivery systems for delivery to brain and cancerous tissues. Prior to DKSH, he had assignments with Cipla Ltd, Mumbai for 3 years and Emcure Pharma, Pune for 1 year in department of Formulation development NDDS (SMEDDS, microsphere, cochleates and liposome based injectable formulations).

He had awarded with Ph.D. in Nov 2015 by Bharati Vidyapeeth from Department of Engineering and Pharmacy. Did post graduation diploma in intellectual property law from New Law College Pune in 2010. 

Have 1 US and 1 Indian patent in drug delivery and more than 20 international publications with cumulative impact factor of more than 12, Reviewer for Journal of Nanoparticle Research and Royal Society of Chemistry Advances.

 

Sources:

https://www.pharmaexcipients.com/news/ashland-announces-klucel-xtend-hpc-matrix-former-for-extended-release-tablets-2/

https://www.biospace.com/article/ashland-helps-make-tablets-easier-to-swallow-with-new-klucel-exf-ultra-hpc-a-low-friability-high-strength-binder-/

https://www.ashland.com/file_source/Ashland/Product/Documents/Pharmaceutical/PC_11229_Klucel_HPC.pdf

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