Press Roundup

August 2008 - Suitability of different excipients for roller compaction by using a pneumohydraulic single-punch press as a model roller-compactor

Roller compaction is increasingly chosen as a standard granulation technique. This technique has several advantages and requires the use of suitable excipients. This article describes the compaction profiles and disintegration results of roller compacted excipients. STARLAC^®, a lactose starch compound, is shown to be particularly suitable for roller compaction applications.

November 2007 - Evaluation of a Novel Modified Starch Polymer in an Easy to Formulate Thin-film Drug Delivery System and Comparison with Some Marketed Formulations

(AAPS 2007)

The poster presents an evaluation of LYCOAT^®NG73 Orodispersible Films (ODFs) and their advantages over the ODFs currently marketed.

December 2007 - Roquette Pharma - Making life better

(PHARMANUFACTURING 2007)

Mannitol is becoming a centre piece excipient in the formulators toolbox.

May 2007 - Water soluble progesterone–hydroxypropyl-β-cyclodextrin complex for injectable formulations

(Incl Phenomen Macrocycl Chem)

Description of a progesterone formulation development using HPBCD. A new production process for the progesterone/HPBCD complex was developed removing the insoluble progesterone and native betacyclodextrin complex.

November 2006 - Functional Advantages of a Novel Modified Starch over HPMC in Aqueous Film Coating of Tablets

(AAPS 2006)

The poster highlights the significant advantages of LYCOAT®, a specially pregelatinized, new-generation, hydroxypropyl starch polymer, over HPMC in aqueous film coating.

October 2006 - New Dextrins supplementing Fiber with Innovation

(Pharmaceutical Technology 2006)

Formulations containing a novel soluble dextrin fiber have been shown to exhibit several advantages in processibility and clinical response over those containing existing fibers.

April 2006 - Influence of lubricants on the tableting and disintegration time of tablets made up of co-processed excipients vs. the physical blends

(5th World Meeting Geneva 2006)

The study highlights the effect of lubricants on the disintegration time of the co-processed excipient vs. the physical blend. Other important characteristics like tablet hardness and ejection force are also reported.

April 2006 - Water soluble Progesterone-hydroxypropyl-β-cyclodextrin complex for injectable formulations

(5th World Meeting Geneva 2006)

Progesterone is a natural hormone utilized as a drug to control reproductive function and for postmenopausal therapy. Out of the existing administration routes, the injectable route is the preferred choice because of higher bioavailability. However the existing pharmaceutical forms allow intramuscular injection only and this has encouraged the research of new water soluble injectable pharmaceutical forms. The study shows that, due to high water solubility, hydroxypropyl-β-cyclodextrin (HPBCD) is the best cyclodextrin choice for a formulation with therapeutic amount of progesterone.

March 2006 - Preformulation study of Fast Melting Tablets

(5th World Meeting Geneva 2006)

Mannitol selected as the best filler to further optimize physical stability, mouth feel and fast disintegration of type-C polymethacrylate-containing Fast Melting Tablets.

November 2005 - From Commodities to Specialized Excipients

(Pharmaceutical Formulation & Qu

Considered a traditional excipient and trusted through many years of use, starch is also the source of a variety of complex excipient derivatives.

November 2005 - Screening and identifying optimal combinations of excipients and super-disintegrants in the development of orally disintegrating tablet (ODT) formulations

(AAPS 2005)

The study assesses the suitability of excipients and superdisintegrants for developing an ODT platform using conventional and non-conventional tests. This data may ultimately help in selection of the best possible combination of excipient and superdisintegrant for developing an optimal ODT formulation.

June 2004 - Starches, a versatile source

(Pharmaceutical Formulation & Qu

One of the best-known excipients in use in various pharmaceutical formulations, starch is still in the forefront of innovation. The article reviews the many advantages of starch and its derivatives, from the simple functionalities to highly specialized starch derivatives that facilitate the formulation of novel drugs.

June 2004 - Added functionality excipients: an answer to challenging formulations

(Pharmaceutical Technology)

Added functionality excipients facilitate the development of novel drug delivery methods and improve processing techniques. The article focuses on added functionality mannitols and pregelatinized starches.

March 2004 - Determination of the Suitability of Different Pharmaceutical Excipients for Roller Compaction by Using a Pneumohydraulic Single-Punch Tablet Press as a Model Roller Compactor

(Powtech 2004)

The main purpose of this study was to find an excipient that tolerates dual compression without a decrease of tensile strength. In particular StarLac^® 25/75 has been shown to be almost non-sensitive to dual compression. Further types of StarLac with different ratios of lactose monohydrate and maize starch have yet to be tested.

October 2003 - Influence of Various Lubricants on Tablet Characteristics of Lactose and Starch Based Mixtures

(AAPS 2003)

The study highlights the influence of various lubricants on the ejection force, tablet hardness and disintegration time of a compound vs. the physical blend based on lactose and starch.

October 2003 - The influence of lubricants on the tableting and disintegration time of tablets made of lactose-starch-blends or of STARLAC

(AAPS 2003)

Starlac^® has been developed to offer a well-adapted material for the direct compression with higher performance in tableting compared to the simple blend of its components. The concept of Starlac includes the optimization of its disintegration properties. It was therefore of interest to study the influence of several different lubricants on the disintegration time of systems based on starch and lactose monohydrate.

October 2003 - Influence of partially pregelatinized starches on the dissolution of drugs with varying solubility from capsule formulations

(AAPS 2003)

The study compares the effect of partially pregelatinized starches on the dissolution rate of highly soluble, not very soluble and poorly soluble drugs from capsule formulations.

October 2002 - Tableting of STARLAC compared to tableting of binary mixtures from spray-dried lactose and maize starch

(AAPS 2002)

Aim of this study is to characterize both the pure substances and the physical mixtures of spray-dried lactose and maize starch in comparison to the new direct compression excipient StarLac. Flowability and tableting properties indicate that StarLac^® is a useful new excipient for direct compression. Among its main advantages are: a higher plastic deformability, and a better compactibility and flowability.

June 2002 - STARLAC® - A star is born

(Pharmaceutical Formulation & Qu

Roquette and Meggle GmbH, two leading excipient producers, teamed up to develop STARLAC^®, a starch-lactose compound that offers the advantages of both entities without any of their drawbacks. The article describes the characteristics of the new product and its many benefits in solid dosage applications.

April 2002 - Co-processed Compound Based on Lactose and Starch Compared to Physical Mixtures :Tablet Formation and Disintegration at Different Maxium Relative Densities

(APV/APGI 2002 ; AAPS 2002)

Direct compression is a major formulation process in pharmaceutical technology. StarLac^® is a new direct compression excipient, produced by spray-drying of α - lactose-monohydrate and maize starch. The study describes in detail the superior tableting properties of the product. The following aspects are considered: pressure-time-profiles, pressure-porosity-profiles, compactibility-plots, disintegration and drug release.

April 2002 - Properties of a Co-processed Compound Versus the Physical Blend based on Lactose and Starch

(APV/APGI 2002)

StarLacTM is a new co-processed excipient, based on 85% lactose and 15% starch, commercially available for direct compression. Purpose of the study is to compare the powder and tablet characteristics of this new compound vs. the physical blend based on lactose and starch. The most important characteristics for direct compression like compaction behavior, stability of the compound, flowability, Mg-stearate sensitivity and disintegration as well as dissolution are highlighted.

April 2002 - Use of partially pregelatinized corn starch as filler for two pieces hard gelatin capsules

(APV/APGI 2002)

Roquette has recently developed LYCATAB^® C as a filler-disintegrant for two-piece hard gelatine capsules. The study compares the performance of LYCATAB^® C with the similar excipient Starch 1500^® in this application.

October 2001 - Influence of Magnesium Stearate on the Compaction Behavior and Tablet Characteristics of Co-Spray Dried Compounds versus Physical Blends

(AAPS 2001)

The study evaluates the influence of Mg-Stearate on the compaction and tablet behavior of co-spray dried compounds versus physical blends based on lactose and starch or lactose and MCC.

October 2001 - Properties of a Co-Processed Compound versus the Physical Blend based on Lactose and Starch

(AAPS 2001)

The study compares the powder and tablet direct compression characteristics of a spray-dried lactose-starch compound versus the physical blend of spray-dried lactose and native white corn starch.

October 2001 - Comparison of the Tableting Properties of a DC Lactose/Starch Compound versus a Physical Blend of DC Lactose and DC Starch

(AAPS 2001)

A new DC compound made of lactose and starch is now commercially available. To evaluate the interest of such a product it has been compared to a physical blend of DC lactose and native starch, and a blend of other DC excipients (spray dried lactose and partially pregelatinized starch).