Pharmatrans Sanaq - Pharma Excipients

PHARMATRANS offers excipients and active ingredients of outstanding quality and performance. With our research & development skill and tradition we commit to study innovative technological solutions providing excipients contributing successfully to smart and efficient pharmaceutical formulations. We offer value added functional solutions to your formulation in solid dosage delivery systems and related technologies.

Direct Compression

The processing of drug with excipients can be achieved without any need of granulation and related unit operations. By simply mixing in a blender, formulation ingredients can be processed and compressed into tablets without any of the ingredients having to be changed.

The successful application of direct compression technique in tablet manufacture especially for low and medium dosage range of drugs can be attributed to the availability of new excipients, modified form of old excipients.

The processes involved in the manufacture of tablets by direct compression method can be summarized in different steps (i.e. Direct compression technique using induced die feeders; Direct compression technique using dry binders) or using specifically excipients.

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Direct compression technique using direct compression excipients

A direct compression excipient also referred to as direct compressible excipient or direct compression filler/binders are inert, non-medicinal substances which may be compacted with no difficulty and which may do so even when mixed with drug substances. Direct compressible excipients should exhibit satisfactory tabletting characteristics. This is because they determine the overall characteristics of the tablet, particularly in regard to the fluidity of the component powders. Direct compressible excipients can also influence the hardness, disintegration and dissolution characteristics of the finished tablets.

The production of tablets by direct compression necessitates the inclusion of certain grades of excipients to achieve the correct powder flow and compression properties. These excipients have typically been prepared by specific methods to achieve the correct physicochemical properties (e.g., particle size/distribution and flow properties) and consist in;

Diluents/fillers
Disintegrants
Lubricants
Glidants

Our Platforms for Direct Compression: DICOM SANAQ line

Pharmatrans approach and vision in DC wants to go ahead exploring customized excipients to provide materials tailored to be used for DC.

DICOM SANAQ offers readymade blends for direct compression and sustained release formulations helping you to find what you are looking for.

Click to enlarge:

Applications fields DiCom SANAQ® products

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Pharmatrans Spheres SANAQ® USP/Ph.Eur neutral pellets

Pharmatrans Sanaq’s Spheres SANAQ® are neutral pellets.
The company portfolio offers pellets based on Sucrose and maize starch; Mannitol and Calcium carbonate. All these beads meet standards defined in the USP40-NF35, Ph. Eur and JP pharmacopoeia monographies.
These spherical cores can be used as a neutral basis for the production of pellets loaded with active pharmaceutical ingredient (API).
Sugar Spheres SANAQ® are designed for the production of dry dosage forms, especially for formulations with a controlled release of the active substance (sustained release).
The multiparticular system is ideal for filling for capsules, sachets or tablets, where the neutral starter cores can be combined with different technologies for layering and coating.
Such technology is used in the pharmaceutical industry but also with nutraceuticals, food supplements, and in the food industry.
Pharmatrans Spheres SANAQ® are available in a range of 11 different types, with particle size distribution (PSD) ranging from 212-300 µm to 1,000-1,180 µm.

Full PSD specifications (tested in house) are tabulated below:

Pharmatrans SANAQ^® LS 004 co-processed Starch/Lactose excipient

Pharmatrans Sanaq now offers SANAQ® LS 004 as a co-processed excipient based on mix 15/85 of maize starch and lactose monohydrate.

LS 004 forms an ultra-uniform and highly compressible lactose excipient for tablet fillings that supports direct compression (DC) applications, aiding tablet hardness, faster disintegration, and superior flowability.

Its high bulk weight supports formulation of high weight tablets, maintained capsule fill weight using smaller dies or capsule sizes.

DICOM SANAQ® LS 004 benefits

The mix in SANAQ LS 004® is composed of lactose monohydrate (85%) and maize starch (15%) and exhibits excellent free powder flowability compared with physical mixtures in the same ratio of components that show extremely poor flow properties.

SANAQ LS 004 has an average particle size distribution (PSD) of 300 to 550 microns and is designed for direct compression providing help to improve tablet hardness and faster disintegration, independent from tablet hardness and lubricant level.

Download the SANAQ^® LS 004 brochure here

Tangible tableting benefits include:

Uniform drug distribution
Content uniformity
Superior compressibility with suitable fines content
Reduced weight variation
Higher production rates
Choice of higher average weight
Robust tablets with reduced friability

LS 004 Specifications:

Test	Results
Bulk density(g/ml)	0.663
Tapped density (g/ml)	0.840
Hausner’s ratio	1.27
Compressibility index	21.05
LOD (105 OC -3h)	2.30
Angle of repose	36.22
PSD Malvern Mastersizer)	D(10) = 34.1 D(50) = 243 D(90) = 583

Cellets® Microcrystalline Cellulose Pellets:
a safer and easier way to multiparticulate dosage forms

Pharmatrans Sanaq supplies Cellets® as a stand-alone brand for its highly optimized
Microcristalline Cellulose MCC Pellets used as an alternative to sugar pellets for retard
formulations and innovative drug delivery.

Cellets® have tangible advantages over sugar pellets in supporting dosage formulations optimized
for homogeneous distribution and controlled release, as defined by the monographs of European
and US pharmacopeias.

What is microcrystalline cellulose?
Microcrystalline cellulose (MCC) is a naturally occurring polymer composed of linear cellulose
chains of glucose units connected by a 1-4 beta glycosidic bond. These are naturally bundled
together as microfibrils spirals in plant cell walls, meaning that MCC can be derived from refined
wood pulp.

Microcrystalline cellulose can also be synthesized from α-cellulose precursor, using processes such
as reactive extrusion, enzyme mediated, mechanical grinding, ultrasonication, steam explosion
and acid hydrolysis.

Pharmatrans manufactures Cellets® under GMP conditions using MCC from certified suppliers
only and can supply these innovative micropellets in various particle sizes from 100 μm to 500
μm.

Cellets® applications
MCC is used as a texturizer, an anti-caking agent, a fat substitute, an emulsifier, an extender, and a
bulking agent. In the pharma industry, its most common use is to modify dosage delivery in
tablets. In this application, properties such as particle size, density, compressibility index, angle of
repose, powder porosity, hydration swelling capacity, moisture sorption capacity, moisture
content, crystallinity index, crystallite size, and hardness and tensile strength mechanical
properties become relevant.
Approved within the European Union as a thickener, stabilizer or emulsifier, microcrystalline
cellulose has E number E460(i), as compared with E460 basic cellulose. These forms have been
defined by monographs for Microcrystalline Cellulose (Ph. Eur., USP-NF). DMF N° 18519 since July
15, 2005.

Cellets® advantages
Cellets® support the pioneering development of multiple dosage forms that deliver more reliable
formulations thanks to the homogeneous concentration of highly active agents.
Two fundamental advantages of the microcellulose MCC-based multiple dosage form are
homogeneous distribution of the active ingredient and its controlled release.
Compared with sugar pellets, MCC pellets have superior (smoother) surface and sphericity
properties, making them a clear first choice for non-dissolving applications. Sugar pellets can be
preferred where fast dissolution in water is desired.

Cellets® deliver a persuasive range of user benefits:
• Perfect tool for combinatory and controlled release products.
• Wide range of particle size fractions with uniform spherical shape and structure.
• Narrow particle size distribution within each fraction.
• Formulation of sensitive actives due to the inertness of MCC.
• High abrasion resistance for superior coating process
• Excellent compactibility due to the high plasticity of the CELLETS® for formulation of
multidosage tablets.
• Higher payload permitting smaller capsule sizes.

Download the product poster here:
(click pictures to download)