Meggle Products & Services

Sieved, milled and micronized alpha-lactose monyhydrate for dry powder inhalation – InhaLac®


Sieved, milled and micronized alpha-lactose monyhydrate for dry powder inhalation – InhaLac®


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Products & Services | MEGGLE Excipients & Technology

To learn more about MEGGLE’S sieved, milled and micronized alpha-lactose monyhydrate for dry powder inhalation: InhaLac®, please click on the brochure below:

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Resources

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Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


MEGGLE co-processed excipients


MEGGLE co-processed excipients


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Products & Services | MEGGLE Excipients & Technology

Overview

MEGGLE are specialists in processing lactose to produce pharmaceutical excipients (substances other than the active ingredient to be included in a drug delivery system).

The purpose of the excipient is to aid processing during manufacture, enhance stability or bioavailability, assist product identification or in some other way enhance overall safety and effectiveness of the product in storage or use.

The wide range of MEGGLE excipients include co-processed excipients that are innovative, superior products exhibiting unique functional characteristics that cannot achieved through simple blending.

Co-processed excipient basics

Pharmeuropa defines a co-processed excipient as “any combination of two or more excipients obtained by physical co-processing that does not lead to the formation of covalent bonds.”

This means that co-processed excipients have functionalities that are not achievable through mere sample blending.

The pharmaceutical industry first started to use co-processed excipients from the late 1980s, with early examples including co-processed microcrystalline cellulose and calcium carbonate, introduced in 1988, MEGGLE’s co-processed cellulose and lactose (1990), and co-processed glucomannan and galactomannan (1996).

In all co-processed excipients, the combination of ingredients is designed to maximize performance and functionality.

Co-processed excipients can be produced using a variety of processes that include dispersion with high shear mixer, co-milling, homogenization, co-precipitation, co-crystallization, wet granulation, extrusion or hot melt extrusion and spray-drying.

MEGGLE co-processed excipients

MEGGLE offers five principal brands of co-processed excipients intended for direct compression (DC) tableting applications. All combine ingredients that are recognized under international pharmacopeias and well-established for use in the pharmaceutical industry.

Cellactose® 80
The MEGGLE Cellactose® range combines 75% alpha-lactose monohydrate with 25% cellulose powder as functional excipients for oral solid dosage forms, using co-spray drying to integrate the ingredients into a monoparticulate structure with narrow particle size distribution (PSD), while retaining their individual chemical identities. This creates synergistic functional performance advantages, principally improved compactibility, flowability, mixing characteristics and increased adherence capacity, which reduces the segregation tendencies typical of simple powder blends. Cellactose® 80 was developed to offer the compaction and flow properties necessary for DC tableting, where its superior compaction properties increases tablet hardness in high dose and low-dose formulations. Cellactose® 80 may also be used in other formulation applications such as dry granulation and capsule filling.

MicroceLac® 100
MicroceLac® 100 uses co-spray drying to combine 75 % alpha-lactose monohydrate and 25 % microcrystalline cellulose (MCC) into a monoparticulate system having brittle fracture and plastic deformation compaction mechanisms, with individual particles that retain their distinctive chemical identities. MicroceLac® 100 maximizes formulation development flexibility, providing the compaction and flow properties desired for DC tableting that may also be applied to other formulation development approaches such as dry granulation and capsule filling. Its enhanced compaction and superior flowability improve blending and mitigate API content variability typical of simple powder blends. These superior blending characteristics make it ideal for API content uniformity critical low-dose formulations, while its compaction properties help increase tablet hardness, making it well-suited for high-dose formulations as well.

StarLac®
StarLac® combines 85 % alpha-lactose monohydrate and 15 % maize starch (corn starch) as functional excipients used in oral solid dosage forms. To establish synergistic functional performance, such as enhanced compactibility and faster tablet disintegration, lactose and starch are co-spray-dried to form a monoparticulate system. StarLac® provides compaction and lubricant insensitivity characteristics desired for DC, and the hydration properties desired for rapid API release. Additionally, StarLac®’s flowability is superior compared to a physical blend of the individual components in equivalent ratio. This makes it an ideal co-processed excipient for DC tableting that can also be used across a range of dry granulation formulations.

CombiLac®
High-functionality CombiLac® is an integrated, co-processed ready-to-use excipient, specifically designed to ease oral solid dosage form development and manufacture by combining 70 % alpha-lactose monohydrate, 20 % microcrystalline cellulose (MCC) and 10 % white, native corn starch into a monoparticulate structure that is not separable by physical means. It is the co-processed excipient of choice for applications where robust, time saving development of frequently used formulation ingredients is the top priority, since the ternary combination reduces requirement for raw material testing during production. CombiLac® shows improved compaction properties compared to an equivalent admixture of individual ingredients, providing robust tablets with minimal friability and assuring rapid, hardness independent tablet disintegration for effective API release. It features the powder flow characteristics necessary to enhance dosage form weight uniformity and throughput in DC but may also be used in other formulation development approaches, such as dry granulation. In comparison to a physical admixture of individual components, CombiLac® provides enhanced compaction properties, as well as the flow performance necessary for increased production rates and decreased weight variation.

RetaLac® sustained release
RetaLac® is the first hypromellose/lactose-based, co-processed excipient specifically designed for DC and dry granulation of modified release formulations. RetaLac® is binary in composition but monoparticulate in structure, having hypromellose and lactose in each particle. It is characterized by superior functional performance such as improved flow and blendability. Additionally, the monoparticulate structure, gives RetaLac® both plastic and brittle fracture deformation characteristics, enhancing compactibility in DC compared to traditional wet granulated and physical admixtures of the parent ingredients.

API release is controlled predominately by diffusion through the hydrophilic matrix, and is most robust in the range of pH 1 to 7.4. For example, with Vitamin C in a sustained release formulation, use of RetaLac® makes it possible to achieve a simplified sustained release of Vitamin C in excess of 80 % after eight hours using DC, where compaction force of 200 MPa resulted in a tablet hardness of approximately 100 N with a corresponding friability of 0.5 %. To minimize development time, it is possible to predict API dissolution as a function of tablet geometry, aided by RetaLac®’s dramatic improvement in wettability compared to hydroxypropyl methylcellulose (HPMC) alone or traditional wet granulations and simple admixtures.

Contact

MEGGLE Excipients & Technology
Tel: +49 8071 73 394
Email: service.pharma@meggle.de

Resources

Click on MEGGLE co-processed excipients for more information
Click on MEGGLE to contact the company directly.
Click on Cellactose® 80 to download product information.
Click on MicroceLac® 100 to download product information.
Click on StarLac® to download product information.
Click on CombiLac® to download product information.
Click on RetaLac® to download product information.

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Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


Wet Granulation – MEGGLE Excipients & Technology


Wet Granulation – MEGGLE Excipients & Technology


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Products & Services | MEGGLE Excipients & Technology

Overview

Wet granulation is a subset of the overall granulation process of size enlargement by combining mixtures of fine powders into larger agglomerates or granules. The wet granulation process adds a liquid solvent and a binder material to an agitated powder bed to form granules.

While Direct Compression (DC) is the usual method of tablet manufacture, it may not be appropriate for some active substances, leaving wet granulation as the preferred alternative.

MEGGLE offers excipients that can optimize wet granulation and also provide direct compression alternatives.

Wet granulation basics

In the traditional wet granulation method, a moistened mass is sieved to produce wet granules that are subsequently dried, with a subsequent screening stage to eliminate agglomerates.

Wet granulation using organic solvents is preferred for water-sensitive drugs, as an alternative to dry granulation, or when rapid drying is required.

The pharmaceutical industry depends on several types of wet granulation equipment , principally fluid bed granulators where air is blown upwards through the powder to agitate and fluidize the particles or mixer granulators that agitate the powder using a large impeller in mixer bowl.

As with dry granulation and DC, wet granulation requires manufacturers to blend APIs with appropriate excipients.

Lactose in wet granulation

Lactose is among the most frequently used excipients for granulation in pharma applications, offering good compression and blending properties. However, like many other excipients, unmodified lactose may not be suitable for direct compression due to insufficient flowability and compactability. As Figure 1 illustrates, lactose-based excipients meet the needs of wet granulation where compressibility is low but where powder flows are highly variable.

MEGGLE milled alpha-lactose monohydrate grade lactose for wet granulation: GranuLac® and SorboLac®

Numerous global and regional pharmaceutical manufacturers have historically relied on MEGGLE milled alpha-lactose monohydrate grades as diluents in dry and wet granulation processes, due to their chemical and physical stability, in oral, parenteral and inhalative pharmaceutical applications, versatile binder-filler properties, and global availability.

Milled GranuLac® and SorboLac® have a small particle size and support a wide range of applications including, wet granulation, dry compression, premixes, triturations, fermentation and flavor off-set. The range includes GranuLac® 70, GranuLac® 140, GranuLac® 200, GranuLac® 230 and SorboLac® 400.

During the milling process, finer, sharper-edged particles are formed, having cohesive powder properties that can be beneficial during granulation processes. Clean unlubricated surfaces created during the compaction process as a result of brittle fracture lead to improved compactability.

In summary, MEGGE’s milled alpha-lactose monohydrate grade lactose grades offer a clear set of benefits that include:

  • Good compactability
  • Narrow particle size distribution
  • Good blending properties
  • High storage stability
  • High batch-to-batch consistency

MEGGLE co-processed lactose grades for wet granulation : StarLac®

Alpha-lactose monohydrate and maize starch (corn starch) are functional excipients used in oral solid dosage forms. Both are naturally derived and well established in the pharmaceutical industry. Lactose is frequently used as a diluent or wet granulation binder. Starch can be used as a binder for wet or dry applications, disintegrant, and diluent. In an effort to establish synergistic functional performance, such as enhanced compactability and faster tablet disintegration, lactose and starch were co-spray-dried to form a monoparticulate system. StarLac® comprises 85 % alpha-lactose monohydrate and 15 % native maize starch. StarLac® provides compaction and lubricant insensitivity characteristics desired for wet granulation, along with the hydration properties desired for rapid API release. Additionally, StarLac®’s flowability is superior compared to a physical blend of the individual components in equivalent ratio.

These and other properties, such as excellent compactability, rapid hardness-independent tablet disintegration and compaction and hydration properties independent of hydrophobic lubricant type or level, also make Starlac useful for dry granulation and ODT formulations.

MEGGLE hypromellose-lactose alternative to wet granulation: RetaLac ®

RetaLac® is the first hypromellose/lactose-based, co-processed excipient specifically designed for DC and dry granulation of modified release formulations.

Although hypromellose offers broad flexibility in tailoring API release due to differing substitution levels and molecular weights, processability has generally been limited to traditional labour, time, and energy intensive wet granulation manufacturing methods.

Recently, through a proprietary agglomeration process, MEGGLE has succeeded in producing RetaLac® as a co-processed composition comprising hypromellose and lactose, offering suitable alternatives to overcome these limitations. Possessing enhanced functional performance, the new excipient offers characteristics desired in formulation development and manufacture and may be of significant interest to innovator and generic pharmaceutical companies.

RetaLac® is binary in composition but monoparticulate in structure, having hypromellose and lactose in each particle. It is characterized by superior functional performance such as improved flow and blendability. Additionally, the monoparticulate structure gives RetaLac® both plastic and brittle fracture deformation characteristics, enhancing compactability in DC compared to traditional wet granulated and physical admixtures of the parent ingredients.

API release is controlled predominately by diffusion through the hydrophilic matrix, and is most robust in the range of pH 1 to 7.4. To minimize development time, API dissolution prediction as a function of tablet geometry is possible. This is aided by RetaLac®’s dramatic improvement in wettability compared to HPMC alone or in traditional wet granulations and simple admixtures.

In processability, RetaLac® shows superior performance to physical admixture and wet granulated formulation.

Contact

MEGGLE Excipients & Technology
Tel: +49 8071 73 394
Email: service.pharma@meggle.de

Resources

Click on MEGGLE Excipients & Technology: Wet Granulation for more information
Click on MEGGLE to contact the company directly.

Figure 1: Basic lactose performance matrix of powder blend compressibility and flowability requirements for wet granulation (WG) dry granulation(DG) and  direct compression (DC) technologies.

Figure 1: Basic lactose performance matrix of powder blend compressibility and flowability requirements for wet granulation (WG) dry granulation(DG) and direct compression (DC) technologies.

Granulac® and Sorbolac®: milled to form finer, sharp-edged particles for cohesive properties beneficial in wet granulation

Granulac® and Sorbolac®: milled to form finer, sharp-edged particles for cohesive properties beneficial in wet granulation

Granulac® and Sorbolac® offer convenience and long shelf life

Granulac® and Sorbolac® offer convenience and long shelf life

Granulac® and Sorbolac® milled/sieved lactoses exhibit the excellent flowability characteristics so important in wet granulation

Granulac® and Sorbolac® milled/sieved lactoses exhibit the excellent flowability characteristics so important in wet granulation

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Milled and sieved alpha-lactose monohytrates are useful across a wide range of pharma applications

Milled and sieved alpha-lactose monohytrates are useful across a wide range of pharma applications


Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


NEW InhaLac® 160: MEGGLE extends inhalative lactose grade portfolio


NEW InhaLac® 160: MEGGLE extends inhalative lactose grade portfolio


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Products & Services | MEGGLE Excipients & Technology

Overview

MEGGLE’s newest sieved grade of lactose monohydrate, InhaLac® 160, is ideal for pulmonary and nasal dry powder inhalation applications.

Characterized by a median particle size of approximately 110 μm, the new InhaLac® 160 fills a gap in the InhaLac® range of coarse sieved lactose grades for dry powder inhalation, sitting between the coarser lactose InhaLac® 120 and the finer lactose InhaLac® 230.

This GMP/GDP certified sieved lactose is therefore suitable for pulmonary and nasal drug delivery and offers a range of benefits that include a dedicated production process, highly controlled powder characteristics, highest microbial quality including low endotoxins and retesting after 24 months.

Design & Features

Developed at MEGGLE’s Wasserburg laboratories in Germany, this inhalation grade lactose exhibits a narrowly distributed particle size with a fines content (particles below 15 μm) of 3%. Combined with high quality and safety, this material will meet individual requirements for dry powder inhalation formulations.

InhaLac® 160 features a particle size distribution between the coarser lactose InhaLac® 120 and the finer lactose InhaLac® 230 of:

  • x10: 55-85 µm
  • x50: 90-120 µm
  • x90: 125-165 µm

User benefits:

InhaLac® 160 is a sieved lactose monohydrate for inhalation with distinct particle size distribution that extends MEGGLE`s product portfolio of inhalative lactose grades, closing the gap of coarse sieved lactose grades for dry powder inhalation. In summary, InhaLac® 160 offers a potent range of overall benefits:

  • Highly controlled powder characteristics
  • Highest microbial quality including low endotoxins
  • High stability means retest is only required biennially

Quality & Certification

MEGGLE’s InhaLac® alpha-lactose monohydrate grades comply with the current harmonized USP-NF, Ph.Eur., and JP monographs. The strict microbial limits of MEGGLE`s InhaLac® formulations characterizes them as inhaler grades to meet the special requirements for dry powder inhalation. All InhaLac® products are manufactured on product lines that are exclusively dedicated to inhalative lactose.

The pharma-dedicated MEGGLE production facility in Wasserburg, Germany holds an EXCiPACTTM Certificate and has implemented GMP according to the Joint IPEC-PQG Good Manufacturing Practices Guide.

In addition, MEGGLE is certified according to DIN EN ISO 9001:2008 (Quality Management), DIN EN ISO 14001:2004 (Environmental Management) and DIN EN ISO 50000:2014 (Energy Management).

MEGGLE invests considerably in raw material resource sustainability, production standards and efficiency and is actively engaged in environmental protection. Lactose meeting pharmaceutical standards is MEGGLE`s first priority.

Specifications and regulatory documents can be downloaded from https://www.meggle-pharma.com/.

Technical specifications

InhaLac® 160 Microbiology

Parameter Specified
Total aerobic microbial count (TAMC) NMT 10 cfu/g
Total combined yeasts and molds count (TYMC) NMT 10 cfu/g
Bile tolerant gram-negative bacteria absence/10g
Escherichia coli absence/10g
Pseudomonas aeruginosa absence/10g
Staphylococcus aureus absence/10g
Salmonella spp. absence/10g
Burkholderia cepacia absence/10g
Bacterial endotoxins NMT 5 EU/g

  

InhaLac® sieved range: Typical powder technological values

Particle size distribution (µm) BET surface area (m2/g) Density bulk (g/ml) Density tapped (g/ml) Hausner ratio Carr’s index (%)
InhaLac® 70 x10: 135 0.13 0.60 0.71 1.18 15
x50: 215
x90: 301
InhaLac® 120 x10: 88 0.15 0.72 0.83 1.15 13
x50: 132
x90: 175
InhaLac® 160 x10: 73 0.12 0.70 0.84 1.19 16
x50: 108
x90: 144
InhaLac® 230 x10: 45 0.16 0.70 0.85 1.21 18
x50: 97
x90: 144
InhaLac® 251 x10: 13 0.33 0.64 0.88 1.38 27
x50: 49
x90: 91

  

Packaging and stability

Sieved grade Size Material Retest
InhaLac® 70 25 kg Carton box with PE-EVOH-PE double inliner 24 months
InhaLac® 120
InhaLac® 160
InhaLac® 230 25 kg Carton box with an aluminium laminated and PE-EVOH-PE inliner 24 Months
InhaLac® 251

  

Contact

MEGGLE Excipients & Technology
Email: service.pharma@meggle.de

Resources

Click on Meggle InhaLac® 160 for more information
Click on MEGGLE to contact the company directly.
Click on Technical information to see detailed specifications.

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Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


MEGGLE Excipients & Technology Direct Compression Expertise


MEGGLE Excipients & Technology Direct Compression Expertise


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Products & Services | MEGGLE Excipients & Technology

Overview

MEGGLE Excipients & Technology are specialists in the lactose-based excipients required to support direct compression (DC) tableting and processing.

MEGGLE offers a wide range of lactose-based compounds that meet all the different requirements for ideal direct compression forms. Its industry-leading comprehensive pharmaceutical excipient portfolio covers solid dosage forms from tablets, capsules, and sachets to powder formulations and dry powder inhalation.

MEGGLE’s direct compression lactose offering extend beyond products, manufacture and supply to technical expertise, process and development consultancy.

Direct Compression challenges

Direct Compression is the most accessible form of tablet production, involving the fewest process stages and quickest production.

Choice of ideal direct compression excipient is defined by a range of factors, including:

  • Need for “DC excipients” particle engineered to ensure correct flow and compression characteristic
  • Consideration of active ingredient dosage levels (low and high)
  • Compatibility with other ingredients with a ‘classic’ direct compression powder mixture usually containing a binder and a lubricant and sometimes a disintegrant and glidant as well

The selection of pharmaceutical excipients for direct compression is more critical than that for granulation in general, or wet granulation in particular. Few traditional excipients combine the functional characteristics, specifically powder flow and compactibility, required for robust direct compression. This makes modifying traditional excipients a necessity.

MEGGLE direct compression excipients

MEGGLE offers a broad range of different lactose-based excipients suitable for direct compression. These products are offered under a range of brand: including Tablettose®, FlowLac®, Cellactose®, MicroceLac®, StarLac®, CombiLac® and RetaLac®, covering three main categories:

  • Agglomerated lactose
  • Spray-dried lactose
  • Co-processed excipients

Direct compression products:

Agglomerated lactose

MEGGLE’s Tablettose® range is manufactured using a continuous spray agglomeration process, where water is used as agglomerating fluid and is sprayed onto fluidized milled lactose particles, creating bonds to form agglomerated lactose.

Tablettose® is purpose-designed for Direct-Compression, combining the flowability of coarse lactose crystals and the high compressibility of milled lactose.

Featuring a broad range of particle size distributions, Tablettose® offers a range of benefits including very good flowability and compactibility, low hygroscopicity, excellent stability, superior blending characteristics and rapid disintegration, it thus supports a wide range of useful applications, including low-dose DC formulations, capsule and sachet filling, effervescent tablets, artificial sweeteners and orally disintegrating tablets.

Spray dried lactose


FlowLac® is produced by spray-drying a fine milled alpha-lactose monohydrate suspension. When lactose is spray-dried, the rapid water evaporation causes amorphous lactose to form. Most commercially available, spray-dried lactose products contain 10 to 15 % amorphous lactose at the time of manufacture, depending on the solids content and process conditions.

Due to the spray-drying process, FlowLac® has a spherical shape, consisting of small alpha-lactose monohydrate crystals bound by amorphous lactose. This provides excellent flow-ability and extraordinary compact-ability compared with other lactose grades.

Other benefits include low hygroscopicity, high stability and fast disintegration times.

The amorphous content and high stability allows achievement of superior DC tableting properties and also supports low to medium dose DC formulations, formulations with poorly flowing APIs, capsule and sachet filling

Co-processed lactose and cellulose

Alpha-lactose monohydrate and cellulose powder are functional excipients used in oral solid dosage forms. Both are naturally derived and well-established for use in the pharmaceutical industry.

In an effort to create synergistic functional performance, such as improved compactability and mixing characteristics, MEGGLE has used co-spray drying to integrate alpha-lactose monohydrate and cellulose powder into a monoparticulate system.

Cellactose® 80 was developed to provide the flow and compaction properties necessary for direct compression tableting, comprising 75 % alpha-lactose monohydrate and 25 % powdered cellulose, both maintaining their individual chemical identities.
While designed for direct compression tableting, Cellactose® 80 can be used in other formulation applications such as dry granulation and capsule filling. In comparison with a corresponding physical blend of the individual components, Cellactose® 80 provides improved compactability, superior flowability, and increased adherence capacity, which reduces segregation tendencies typical of simple powder blends and make it ideal for low-dose formulations.

Alpha-lactose monohydrate and microcrystalline cellulose

MicroceLac® 100 provides the flow and compaction properties desired for direct compression tableting, combining 75 % alpha-lactose monohydrate and 25% microcrystalline cellulose (MCC), both maintaining their individual chemical identities.

To develop synergistic functional performance, such as increased compact-ability and powder flow, alpha-lactose monohydrate and microcrystalline cellulose were co-spray-dried, creating a mono-particulate system having two compaction mechanisms, brittle fracture and plastic deformation, within individual particles.

MicroceLac® 100 is designed for direct compression and may be applied to other formulation development approaches such as dry granulation and capsule filling. In comparison to a physical blend of the individual components, MicroceLac® 100 provides enhanced compaction and superior flowability to improve blending and mitigate API content variability. Superior blending characteristics make MicroceLac® 100 ideal for low-dose formulations where API content uniformity is critical, while excellent compaction properties help increase tablet hardness, making it well-suited for high-dose formulations as well.

Alpha-lactose monohydrate and maize starch

Alpha-lactose monohydrate and maize starch (corn starch) are functional excipients used in oral solid dosage forms. Both are naturally derived and well established in the pharmaceutical industry. Lactose is frequently used as a diluent or direct compression binder. Starch can be used as a binder for wet or dry applications, disintegrant, and diluent.

StarLac® combines 85 % alpha-lactose monohydrate and 15 % native maize starch to provide the compaction and lubricant insensitivity characteristics desired for direct compression, and the hydration properties desired for rapid API release. Additionally, StarLac®’s flowability is superior compared to a physical blend of the individual components in equivalent ratio.

StarLac® is designed for direct compression and may be used in other formulation development approaches. In comparison to a physical blend of the individual components, StarLac® provides superior flow, improved compaction, decreased lubricant sensitivity, and hardness-independent tablet disintegration. Its brittle and plastic deformation characteristics support a range of dry granulation formulations.

StarLac® possesses a narrow particle size distribution (PSD) that supports homogenous powder blend preparation, essential for achieving good tablet quality.

Co-processed hypromellose lactose for direct compression

MEGGLE’s co-processed lactose RetaLac® is the first hypromellose/lactose-based, co-processed excipient specifically designed for DC and dry granulation of modified release formulations.

RetaLac® is a binary composition but monoparticulate in structure, having hypromellose and lactose in each particle. It is characterized by superior functional performance such as improved flow and blend-ability. Additionally, due to its monoparticulate structure, RetaLac® possesses both plastic and brittle fracture deformation characteristics, enhancing compactability in DC compared to traditional wet granulated and physical admixtures of the parent ingredients.

It is particularly useful in supporting the modified release applications that form an important development strategy for the global pharmaceutical industry, particularly in extending the life-cycle of products nearing patent expiration or improving efficacy through more structured active pharmaceutical ingredient (API) release profiles, cost effective product manufacture, and improved patient compliance.

Co-processed lactose, microcrystalline cellulose and starch

MEGGLE’s high-functionality excipient, CombiLac® is specifically designed to ease oral solid dosage form development and manufacture, consisting of 70 % alpha-lactose monohydrate, 20 % microcrystalline cellulose (MCC) and 10 % white, native corn starch, each conforming with Ph.Eur., USP-NF, and JP compendial requirements. These three individual components are integrated into an inseparable monoparticulate structure.

CombiLac® shows improved compaction properties compared to an equivalent admixture of individual ingredients, providing robust tablets with minimal friability. It assures rapid, hardness-independent tablet disintegration for effective API release, and features powder flow characteristics necessary to enhance dosage form weight uniformity and throughput in DC.

Resources

Click on MEGGLE Direct Compression Products for more information
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Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


Co-processed lactose grades for direct compression – CombiLac®


Co-processed lactose grades for direct compression – CombiLac®


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Products & Services | MEGGLE Excipients & Technology

To learn more about Co-processed lactose grades for direct compression – CombiLac®, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Co-processed lactose grades for direct compression – CombiLac® for more information
Click on MEGGLE to contact the company directly.


Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


Co-processed lactose grades for direct compression – StarLac®


Co-processed lactose grades for direct compression – StarLac®


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Products & Services | MEGGLE Excipients & Technology

To learn more about Co-processed lactose grades for direct compression – StarLac®, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Co-processed lactose grades for direct compression – StarLac® for more information
Click on MEGGLE to contact the company directly.


Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


Co-processed lactose grades for direct compression – MicroceLac® 100


Co-processed lactose grades for direct compression – MicroceLac® 100


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Products & Services | MEGGLE Excipients & Technology

To learn more about Co-processed lactose grades for direct compression – MicroceLac® 100, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Co-processed lactose grades for direct compression – MicroceLac® 100 for more information
Click on MEGGLE to contact the company directly.


Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


MEGGLE Excipients & Technology Application Service


MEGGLE Excipients & Technology Application Service


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Products & Services | MEGGLE Excipients & Technology

Overview

MEGGLE Excipients &Technology has upgraded its Application Service, first introduced in the early 1990s to provide comprehensive technical support for their extensive product portfolio.

MEGGLE´s service provides the customer with expert assistance in making choices among a range of viable products. With this support the formulator will find the optimum choice on formulation and dosage forms.

The service is particularly designed to assist formulation development scientists, R&D departments and purchasing managers.

Application Services

The Application Service can assist in resolving a range of detailed issues and challenges for all partners in the industry.

  • Optimizing new and existing solid dosage formulations
  • Formulation optimization with respect to specific production conditions
  • Developing new products
  • Product management and lifecycle management
  • Troubleshooting
  • Selecting the most cost-effective formulation and technical process combination
  • Reducing manufacturing costs
  • Staging in-house, customer-specific seminars and training sessions on all topics related to solid dosage forms
  • Development of new application fields and business strategies
  • Support for customer audits: dossier preparation, regulatory procedures including Ph. Eur., USP-NF, JP, ICH, and FDA requirements

Features

The Application Service is based on MEGGLE’s own extensive expertise in developing innovative, functional products for application in new and existing dosage forms. Along with decades of experience as a leading pioneer in pharmaceutical excipient development MEGGLE is also an innovator in co-processed tableting excipients and direct compression.

Experienced, well-trained and highly qualified application advisors around the world are there to serve different time zones, geographical locations and language requirements.

Meggle has several independent application laboratories in Wasserburg, Germany; São Paulo, Brazil; Shanghai, China and Singapore.

From these locations, the service provides multilingual assistance for the development of new markets, new segments, new application fields and business strategies.

It features a state-of-the-art support service, providing solutions for the pharmaceutical, veterinarian and nutraceutical industry:

  • Co-processed excipients for direct compression
  • Modified lactose (agglomerated and spray dried)
  • Sieved and milled lactose (oral and inhalation grades)
  • Anhydrous lactose

Benefits

The MEGGLE Application Service plays a valuable role in helping customers with their know-how to define ideal applications. MEGGLE provides comprehensive technical specifications and information on the functionality of MEGGLE ingredients and excipients.

MEGGLE’s overall philosophy is to provide customized solutions and service packages rather than just commodity products.

Main customer benefits include:

  • Local, individualized service with quick response time
  • Specific state-of-the-art training
  • Harnessing a global research network
  • Product-specific support
  • Many years of experience in powder technology and spray drying
  • Implementation of strategies to achieve business goals

Resources

Click on MEGGLE Excipients & Technology Application Service for more information
Click on MEGGLE to contact the company directly.
Click on DirectCost to view the video.
Click on Follow Meggle to access the LinkedIn profile.


Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


Co-processed lactose grades for direct compression – Cellactose® 80


Co-processed lactose grades for direct compression – Cellactose® 80


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Products & Services | MEGGLE Excipients & Technology

To learn more about Co-processed lactose grades for direct compression – Cellactose® 80, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Co-processed lactose grades for direct compression – Cellactose® 80 for more information
Click on MEGGLE to contact the company directly.


Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


MEGGLE Excipients & Technology Contract Manufacturing


MEGGLE Excipients & Technology Contract Manufacturing


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Products & Services | MEGGLE Excipients & Technology

Overview

MEGGLE’s Excipients & Technology business division is not just one of the world’s most respected manufacturers of lactose-based pharmaceutical ingredients and excipients worldwide but can also provide contract manufacturing services for its clients from the food, life sciences and pharmaceutical industries.

MEGGLE can take on projects involving spray drying, high shear agglomeration or evaporation. All facilities are state of the art to realize customers’ specific requirements, even highly unusual ones, to very high standards of quality, reliability and accuracy.

The MEGGLE contract manufacturing offer has been upgraded with new and more advanced facilities and is now supported by its own dedicated website.

CMO service portfolio

As a Contract Manufacturing Organization (CMO), MEGGLE Excipients & Technology can offer a wide range of different technical processes and facilities from its modern plants at Wasserburg. These include:

  • Agglomeration
  • Spray Drying
  • High shear agglomeration

Evaporation

MEGGLE is also able to offer more specialized processes. These include:

  • Chemical and/or physical analytics incl. microbiology
  • All options for SEM/DVS/ laser diffractometry/ HPLC/FT4 (rheometry)
  • Comprehensive logistics services – including GDP storage and organization of transportation
  • Process design consultancy

Facilities

The modern MEGGLE facilities at Wasserburg include eight advanced spray dryers, five fluidized bed dryers and 10 Evaporators.

  • Spray Drying Towers: Agglomeration can be achieved by various nozzle atomization of solutions, dispersions and emulsions at up to 200 bars pressure for enhanced product properties like improved powder characteristics, dispersibility and increased PSD. Spray drying capacity varied from 1500 to 3000 kilograms per hour – water evaporation. In addition one processing plant is equipped with a homogenizer unit applying up to 600 bars for various emulsions.
  • Agglomerator: Using High-Shear-Granulator with subsequent fluidized bed drying, MEGGLE can greatly enhance product properties with improved powder characteristics, increased PSD, etc. MEGGLE’s agglomerators boast additional capabilities such as continuous mixing of up to three substances simultaneously.
  • Evaporators: Falling-film evaporators with mechanical/thermal vapor recompression can withdraw water from product at up to 10.000 liters per hour, to achieve maximum concentration of product.

All manufactured products can be packaged in paper sacks (15 – 25 kg) or in Big Bag for quantities of between 500 and 1000 kg.

Quality & standards

MEGGLE recognizes that customers must meet the highest possible standards concerning the quality of products in which the smallest errors in process design or implementation can have devastating consequences.

To this end, all of MEGGLE’s facilities meet the strictest quality and regulatory requirements, including certifications according to ISO 9001:2015, ISO 14001:2004, FAMI-QS, HACCP, IPEC GMP, and EXCiPACT.

MEGGLE can also provide full process or cleaning validation for pharmaceutical products in toll manufacturing.

Resources

Click on MEGGLE Contract Manufacturing for more information
Click on MEGGLE to contact the company directly.
Click on MEGGLE Lohnfertigung for dedicated website.

 MEGGLE Lohnfertigung for dedicated website

MEGGLE Lohnfertigung dedicated website

Continuous fluid bed dryer processing fluidized bulk products

Continuous fluid bed dryer processing fluidized bulk products

Falling film evaporator operated by mechanical/thermal exhaust vapors

Falling film evaporator operated by mechanical/thermal exhaust vapors

Modern spray dryer with external fluid bed dryer qualified according to current GMP guidelines

Modern spray dryer with external fluid bed dryer qualified according to current GMP guidelines


Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


Anhydrous lactose grade for direct compression – DuraLac® H


Anhydrous lactose grade for direct compression – DuraLac® H


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Products & Services | MEGGLE Excipients & Technology

To learn more about Anhydrous lactose grade for direct compression – DuraLac® H, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Anhydrous lactose grade for direct compression – DuraLac® H for more information
Click on MEGGLE to contact the company directly.


Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


Spray-dried lactose grades for direct compression – FlowLac®


Spray-dried lactose grades for direct compression – FlowLac®


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Products & Services | MEGGLE Excipients & Technology

To learn more about Spray-dried lactose grades for direct compression – FlowLac®, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Spray-dried lactose grades for direct compression – FlowLac® for more information
Click on MEGGLE to contact the company directly.


Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


Agglomerated lactose grades for direct compression – Tablettose®


Agglomerated lactose grades for direct compression – Tablettose®


Meggle Pharma

Products & Services | MEGGLE Excipients & Technology

To learn more about Agglomerated lactose grades for direct compression – Tablettose®, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Agglomerated lactose grades for direct compression – Tablettose® for more information
Click on MEGGLE to contact the company directly.


Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


Crystalline alpha-lactose monohydrate grades – Milled and sieved


Crystalline alpha-lactose monohydrate grades – Milled and sieved


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Products & Services | MEGGLE Excipients & Technology

To learn more about Crystalline alpha-lactose monohydrate grades – Milled and sieved, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Crystalline alpha-lactose monohydrate grades – Milled and sieved for more information
Click on MEGGLE to contact the company directly.


Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/