Hydrocel HPMC for Superior Sustained Release Formulations

Hydrocel – Tailored to Perform, is the brand name for Hypromellose/Hydroxy Propyl Methyl Cellulose or HPMC. It is specially designed, or one can say “Tailor Made” for Sustained Release / Controlled Release Formulations, Tablet Film Coating & Pellet Coating.  Hydrocel has been a subject of a continuous program of development, quality improvement and constant innovation of application from tablets for coating to a polymer for imparting specific Drug Release Profile to Rheology Modifier for various Semi-solids & Liquid products to now Veg Capsules leading to its wide spread use throughout the world.

Controlled Drug Delivery for Oral Dosage Forms

Oral dosage forms, which are easy to administer and non-invasive are among the most common formulations of drugs for all ages. To improve efficacy of the drug and avoid frequent doses, extending drug release profile is of great interest in Pharmaceutical Industry.

HPMC plays a major role in Tablets for formulations that are Sustained Release, Controlled Release, Extended Release & for Coating of Tablets and Pellets. The hydrophilic matrix system is the simplest sustained release technology for oral dosage forms, consisting essentially of a drug and a water soluble, highly viscous polymer. It does not require any other excipient as Hydrocel HPMC is a self-sufficient Polymer.

HPMC is a popular matrix material in oral controlled delivery systems and Hydrocel HPMC matrices show sustained release pattern by two mechanisms, i.e., diffusion and erosion of the gel layer. In the recent years, advances in this hydrophilic matrix system have allowed more controllable and reproducible drug release by controlling the chemical and physical properties of the polymer. The viscosity of the polymer affects the diffusion pathway.

Higher Consistency with Hydrocel HPMC

Since FDA has stringent rules & every formulations has fixed release profile on hourly basis, a general monographed HPMC may not be suitable to achieve consistent dissolution/release. Hydrocel-CR (Hypromellose) is especially suitable for this application, and provides a genuine consistency in the final products.

Hydrocel-CR, USP Hypromellose (HPMC), is designed for a hydrophilic matrix agent having tighter specifications, which is especially suitable for wet granulation and direct compression application. Consistency in every batch is of the highest level, as Hydrocel HPMC is developed with stringent in-house specifications with a narrow limit.

All the Pharmacopoeial Monographs as well as manufacturers offer product with 75-140% result of declared value for viscosity. However, our Hydrocel HPMC is developed such that we can provide you material with 90-120% result of Declared value (Narrow range = Higher Consistency). This ensures the Drug Release Profile is consistent and almost a replica of results for each subsequent batch.

Information for best results with Hydrocel HPMC

  • Drug solubility is one of the most influential factors for designing a drug release pattern. Highly water-soluble drugs require higher amounts of HPMC in the tablet.
  • Suitable types of HPMC are the Hydrocel AW and CW grades, especially CW-CR grades, which have a characteristic of quick hydration and gel formation. https://www.pioma.net/portfolio-items/hydrocel-hpmc-hypromellose/
  • The higher viscosity of HPMC or amount of HPMC in the tablet can decrease the drug release rate. Generally, an optimum content of Hydrocel in the tablet is at least 20%. If the content is below 20%, there is a risk for initial erosion or excess dissolution in the first stage. This is applicable for a drug like Metformin HCl. Of course the dosage will differ based on the API, label claim of the API and type of release profile (Monographed or In-House).
  • Various Sustained Release / Controlled Release / Extended Release formulations such as Aceclofenac, Nifedipine, Metoprolol, Pregabalin & many more have been developed using Hydrocel HPMC by our Team and has gained commendable appreciation from Customers across the Industry Worldwide.
  • Preparation method also affects the dissolution profile due to the difference of HPMC particle distribution in the tablet. In the case of wet granulation, most of the water can be taken up by Hydrocel, resulting in the separation of Hydrocel and the other components. (i.e. large particles with high Hydrocel content and ungranulated drug in the fine particle fraction.). Hence, ideal moisture content must be available post drying of granules.

Adjusting the dissolution profile with Hydrocel HPMC

Sustained release dosage forms have number of advantages over conventional dosage forms. It results in less fluctuations of steady state levels of the drug in patients and allows for improved patient convenience and compliance due to less frequent dosing. The oral dosage form should be designed and formulated for the optimal sustained release dosage for your specific purpose.

In case dissolution is too fast:

  • Increase the content of Hydrocel in the tablet formulation.
  • Select higher viscosity grade of Hydrocel.
  • Increase the tablet size.

In case dissolution is too slow: Opposite adjustments of too fast dissolution. Also, you can always get in touch with our Team Pioma who will be happy to assist you on the technical guidelines related to Hydrocel HPMC.

Safety Standards and Pharmaceutical Compliance

HYDROCEL – HPMC is supported with complete documentation. Our product is US DMF certified & our site is US FDA Registered. This speaks volumes regarding the products standards, safety, pharmaceutical compliance. Since it is multi pharmacopoeial (USP/IP/BP/Ph.Eur/JP)  compliant, it is being used for Regulated Markets as well as Domestic market formulations. In addition to all these features & benefit, the cherry on top is that HYDROCEL – HPMC is cost competitive as well.

Our team at Pioma Chemicals is always ready to support our customers with technical queries, documentation & seamless supply of Hydrocel HPMC.

Because of its superior performance and narrow limit, Hydrocel HPMC has found acceptance across the globe within the Pharmaceutical Industry. Its multiple benefits including consistency of results, stability in terms of supply and cost effectiveness has make it popular amongst the Formulators & Research Scientists worldwide as well as its ease of use has garnered tremendous support from the Operations Team at various Pharmaceutical Plants across the Industry. Contact us for more information about Hydrocel HPMC today.

Visit https://hydrocel.net/hpmc.html for more information

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