#Non-reactive excipient for direct compression

[nitikapharmaceutical]

Breaking the Lubrication Barrier: Why Novalube (Sodium Stearyl Fumarate) is Redefining Direct Compression for High-Potency APIs

Introduction

Pharmaceutical formulation has evolved from a linear process into a complex balancing act—especially when it comes to direct compression. High-potency APIs, sensitive excipients, and regulatory stringency now demand excipients that are not just functional, but smart.

Enter Novalube, Nitika Pharma’s high-performance Sodium Stearyl Fumarate (SSF), engineered to overcome the long-standing challenges in direct compression. Unlike conventional lubricants, Novalube offers non-reactive, non-hydrophobic, and low-friction performance without compromising tablet hardness, content uniformity, or dissolution profiles—especially for low-dose formulations.

Understanding the Limitation of Conventional Lubricants in Potent Formulations

Most pharmaceutical manufacturers still rely on Magnesium Stearate, which while widely used, presents significant problems in sensitive or low-dose formulations:

Hydrophobicity interferes with drug dissolution

Incompatibility with acidic APIs

Poor lubrication at low concentrations

Adverse impact on disintegration time

For high-potency drugs or moisture-sensitive compounds, these drawbacks can derail development timelines or affect regulatory outcomes.

What Makes Novalube (SSF) the Lubricant of the Future?

Novalube is a chemically stable, fumaric acid ester of stearyl alcohol, offering lubrication without the drawbacks of metal-based stearates. Its benefits include:

Hydrophilic nature, supporting fast disintegration

Inert profile, making it compatible with a broad spectrum of APIs

Efficient lubrication at low usage levels (0.5–1.0%)

Minimal effect on dissolution and tablet hardness

Because Novalube doesn’t form metal soaps, it is ideal for formulations where API stability, bioavailability, and regulatory compliance are critical.

Key Advantages of Novalube for Pharma Manufacturers

1. Ideal for High-Potency, Low-Dose APIs

Novalube ensures uniform dispersion even at microgram levels. This is vital for hormonal therapies, oncology medications, and controlled-substance formulations where API uniformity and dosage precision are non-negotiable.

2. Compatible with Sensitive and Acidic APIs

Unlike Magnesium Stearate, Novalube doesn’t react with acidic drugs or oxidize over time. Its inertness helps preserve API stability and extends formulation shelf-life—a major win for global regulatory submissions.

3. Enhances Disintegration and Dissolution Profiles

Novalube’s hydrophilic nature ensures that tablet disintegration remains rapid, even with lubricant concentrations up to 1%. This makes it ideal for orally disintegrating tablets (ODTs) and immediate-release formulations.

4. Low Friction, High Reliability in Direct Compression

Its unique particle morphology and fine powder characteristics ensure consistent tablet ejection and reduced die-wall friction, even in high-speed presses—enhancing both throughput and equipment lifespan.

Emerging Trends Fueling Demand for SSF Lubricants

The push for patient-centric design, faster go-to-market timelines, and regulatory scrutiny has created demand for high-functionality excipients like Novalube. Emerging trends include:

Miniaturized dosage forms

Continuous tableting technologies

Formulations with high excipient compatibility

Excipient traceability and QbD documentation

As regulatory authorities like USFDA and EMA focus more on excipient safety and performance, SSF is increasingly favored for ANDA filings, global dossiers, and complex dosage forms.

Application Spotlight: Where Novalube Shines Brightest

Orally Disintegrating Tablets (ODTs): Novalube supports rapid disintegration without impacting taste-masking or mouthfeel.

Modified Release Tablets: In controlled-release systems, it enhances flow and reduces sticking without affecting polymer matrix performance.

Veterinary & Pediatric Formulations: Its inertness makes it safer for sensitive populations.

Nutraceutical Tablets: Supports direct compression with consistent tablet hardness and faster dissolution.

 Partner with a Lubricant Innovator

Are your direct compression formulations facing sticking, poor dissolution, or batch inconsistency?

🔬 Switch to Novalube and experience the next generation of lubricant science. 📩 Request a technical sample, formulation guidance, or documentation tailored for your product pipeline.

👉 Visit Nitika Pharma to discover more. 📧 Email: enquiry@nitikapharma.com | 📞 +91 7122554812

Final Thoughts

In an industry driven by precision, performance, and regulatory compliance, the choice of lubricant can no longer be an afterthought. Novalube (Sodium Stearyl Fumarate) offers a decisive edge—supporting robust, scalable, and compliant formulations across diverse therapeutic areas.

If you’re ready to future-proof your direct compression workflows, it’s time to rethink your lubricant—and Novalube is the solution you’ve been waiting for.

[caltronclays]

Providing High-Purity Egg Shell Calcium Powder – Caltron Clays & Chemicals, a Leading Manufacturer and Supplier in India

Introduction:

Caltron Clays & Chemicals: Natural Egg Shell Calcium Powder Manufacturer and Supplier in India for Clean Pharma Solutions

In a pharmaceutical world that demands efficacy, sustainability, and regulatory compliance, raw material sourcing is more critical than ever. Caltron Clays & Chemicals, a leading Egg Shell Calcium Powder manufacturer and supplier in India, provides a premium-grade calcium solution derived from natural eggshells. With global reach, technical consistency, and an eco-conscious approach, our Egg Shell Calcium Powder has become the preferred choice for modern pharmaceutical formulations.

Bioavailable Calcium Source for Pharmaceutical and Nutraceutical Products

Sourced from food-grade eggshells, Caltron’s natural calcium carbonate powder is rich in elemental calcium and biologically compatible trace minerals. Unlike mined limestone or synthetic sources, it offers:

≥38% elemental calcium

Naturally occurring magnesium and phosphorus

Superior absorption and gastric tolerance

Non-GMO, allergen-free and chemical-free

This positions it as the ideal ingredient for bone health tablets, calcium syrups, and nutraceutical supplements.

Eco-Friendly Calcium Carbonate with Sustainable Sourcing

Caltron Clays & Chemicals champions the circular economy by converting food industry waste into high-value, pharmaceutical-grade materials. Our eco-friendly calcium carbonate solution eliminates the need for environmentally destructive mining while significantly lowering the carbon footprint.

Environmental Benefits:

Zero chemical extraction

Upcycled eggshell waste

Reduced energy consumption in processing

Recyclable packaging options available

Choosing Caltron supports both formulation efficiency and sustainability goals for pharma companies.

High-Absorption Egg Shell Calcium for Enhanced Bioavailability

Our high-absorption calcium powder is designed to deliver optimal therapeutic results across age groups and treatment categories. It supports:

Efficient calcium uptake in the body

Superior retention in bones and tissues

Minimal gastrointestinal side effects

Compatibility with vitamin-enhanced blends (e.g., D3, K2)

This makes it suitable for pediatric care, prenatal health, and osteoporosis supplements.

Formulation-Ready Calcium Powder with Excellent Flow Properties

Pharma manufacturers require raw materials that integrate smoothly into high-volume production. Caltron’s flow-enhanced calcium carbonate meets these demands with:

Uniform particle size distribution

Excellent bulk density and low dusting

Enhanced compressibility for tablet-making

Easy blending with excipients like MCC, starch, and lactose

The result is minimal process loss, improved output, and lower production costs.

Clean Label Ingredient for Modern Drug Delivery Systems

With increasing demand for clean label ingredients in pharmaceuticals, Caltron’s Egg Shell Calcium Powder offers:

Non-synthetic, naturally sourced formulation

No preservatives or artificial additives

Free from allergens, animal hormones, and contaminants

Kosher and Halal compliant on request

This is ideal for brands promoting natural calcium supplements and products aligned with functional nutrition trends.

Versatile Use in Tablets, Suspensions, Chewables, and Functional Foods

Our product is tailored for various delivery systems and formats including:

Tablets and Capsules: Direct compression-ready with strong binding capacity

Liquid Suspensions: Non-settling, stable suspensions for pediatric and geriatric use

Chewable Tablets: Clean taste and low reactivity for high patient compliance

Nutraceutical Foods: Perfect for fortified drinks, powders, and health bars

Whether it’s an oral dosage form or a functional food matrix, Caltron’s calcium supports formulation flexibility.

GMP-Compliant Calcium Powder with Global Quality Certifications

As an internationally trusted Egg Shell Calcium Powder supplier, Caltron provides complete documentation and testing to meet strict global regulations.

Available Certifications and Documents:

ISO 9001:2015 and GMP Certified

COA, MSDS, Heavy Metal & Microbial Reports

USP/IP/EP/JP grade compatibility

Export-ready documents for USA, EU, South Korea, UAE & more

Our team ensures full traceability and transparency from raw shell sourcing to final packaged delivery.

Global Reach with Local Expertise in Pharmaceutical Raw Materials

Caltron Clays & Chemicals serves clients across:

United States

United Kingdom

Germany, Netherlands, France

South Africa

South Korea and Southeast Asia

We offer region-specific regulatory support, custom packaging, and on-time international logistics making us a complete solution provider, not just a raw material vendor.

Custom Mesh Sizes and Technical Support for Pharma R&D Teams

Every formulation is unique, and we understand that. Caltron provides custom particle sizes and technical consultation to streamline your R&D efforts.

Our B2B Support Includes:

Mesh options: 100 to 400 for fine-tuned blending

Sample kits for pre-formulation studies

R&D collaboration for flow rate, pH stability, and compatibility

Bulk ordering with scale-up consistency assurance

From concept to commercialization, we ensure your formulation success.

Why Caltron Clays & Chemicals Is the Top Choice for Pharmaceutical Calcium

With decades of experience, global credibility, and client-focused service, Caltron stands as the preferred Egg Shell Calcium Powder manufacturer and supplier in India.

Our Competitive Advantages:

End-to-end sustainable sourcing

Batch-to-batch consistency

Competitive B2B pricing

In-house quality control and R&D

Fast, responsive customer service

We help brands launch better, safer, and more compliant calcium-based formulations globally.

Build the Future of Clean Pharma with Caltron’s Egg Shell Calcium Powder

Whether you are launching a pediatric health syrup, formulating a new nutraceutical line, or optimizing an existing calcium tablet, Caltron Clays & Chemicals provides the trusted solution.

Our Egg Shell Calcium Powder delivers the ideal balance of purity, sustainability, and technical performance making it your strategic ingredient for the future of pharma.

✅ Experience the Caltron Advantage Today!

🔗 Visit Website: https://caltronclays.com/ 📍 Corporate Office: 210 & 211, Level 2, Orbit Premises, Mind Space, Chincholi, Malad (West), Mumbai – 400064, India 📩 Email: sales@caltronclays.com | business@caltronclays.com 📞 Phone: +91-22-3571 9844 / +91-22-4010 6828 📍 Google Maps Location

[velvexlubricants]

The Essential Role of White Oil P Series in Diverse Industries

White Oils, specifically the White Oil P Series, represent a category of high-purity, severely refined mineral oils, often referred to as liquid paraffin. Composed of saturated and alicyclic non-polar hydrocarbons, these oils possess a remarkable array of characteristics that have made them an indispensable component in various industries. In this article, we will delve into the fascinating world of White Oil P Series, exploring its unique properties and the diverse sectors where it plays a crucial role.

What is White Oil P Series?

White Oils are hydrophobic, which means they repel water, making them ideal for applications where moisture intrusion can be detrimental. Their colourless, odourless, and tasteless nature ensures they leave no trace of their presence, making them suitable for a wide range of applications. Moreover, these oils are biologically stable and non-carcinogenic, which is crucial when they come into contact with products intended for human consumption or sensitive applications.

The Many Faces of White Oil P Series

Pharmaceuticals and Cosmetics

One of the most notable applications of White Oil P Series is in the pharmaceutical and cosmetic industries. These oils are commonly used as excipients in the formulation of various products. Due to their purity and non-reactive nature, they are ideal for topical creams, ointments, and lotions, providing a smooth and non-irritating base. In the pharmaceutical sector, they are used as lubricants for tablet compression and as carriers for certain active ingredients.

Food and Beverage

White Oil P Series is extensively used in the food and beverage industry. They serve as a vital component in food-grade lubricants, preventing equipment from rusting and ensuring a safe manufacturing process. Additionally, they are employed as release agents in food processing, making it easier to remove food products from moulds and packaging. Their non-toxic nature makes them a preferred choice for direct and indirect food contact.

Plastics and Polymers

In the plastics and polymer industry, White Oil P Series plays a pivotal role as a plasticizer and processing aid. They enhance the flexibility and workability of plastics, making them easier to mould and shape. These oils are crucial in the production of PVC, rubber, and other synthetic materials. Their low volatility and resistance to oxidation ensure the longevity of plastic products.

Textiles

White Oil P Series finds application in the textile industry, where it serves as an essential component in spinning and weaving processes. It aids in reducing friction between fibres and machinery, improving the overall efficiency of textile production. Additionally, its non-staining properties make it an excellent choice for textile applications, where colour purity is paramount.

Adhesives and Sealants

The adhesive and sealant industry relies on White Oil P Series for their non-reactive and non-migratory characteristics. These oils are often used to formulate adhesives and sealants that require stability over time. They prevent the degradation of the adhesive and ensure a strong and long-lasting bond.

Rubber and Tire Manufacturing

White Oil P Series plays a crucial role in the rubber and tire manufacturing industry. These oils are used as plasticizers in rubber compounds, improving their elasticity and durability. In tire production, they enhance the performance of rubber, ensuring a smooth and safe ride.

The End

White Oil P Series, with its impressive array of properties, stands as a testament to the versatility of high-purity mineral oils. From pharmaceuticals to plastics, textiles to adhesives, these oils find their place in a multitude of industries. Their hydrophobic, colourless, odourless, biologically stable, and non-carcinogenic nature has made them the standard choice for countless applications.

In a world where purity and performance are paramount, White Oil P Series continues to prove its worth. As technology advances and industries evolve, the demand for these remarkable oils is expected to remain steadfast, underlining their significance in modern manufacturing and production processes. Whether you realise it or not, White Oil P Series is quietly working behind the scenes, contributing to the products and processes that shape our everyday lives.

[juniperpublishersajop]

Co- Excipient: Future of Formulation Industry

Abstract

This article will give complete overview on recent development in co-process excipient technology and approaches involved in its development. The co-processed excipients help to overcome deficiencies occurring with use of single general grade excipients. Formulation scientist recognized that the single component excipient cannot always provide the essential performance in manufacturing or formulation to certain active pharmaceutical ingredient (API). Hence attention on the production of multifunctional excipient with improve performance was seen to meet the need of formulation. In order to justify rise in new drug development and also high industrial output demand new combinations of existing excipient were tested for improving excipient functionality. Now days the particle engineering of individual excipient and their combinations by using co-processing technique has provided an attribute tool for developing high functionality excipients to modern drug delivery system. The co-processing is a process with interaction of two or more excipients at sub particle level which turn to provide a synergy of functionality improvement as well as masking the undesirable properties of individual excipients. It is synergistic outcome of the combination of excipients as material property into consideration .The specific excipients are best suited for particular dosage form as a selection criterion for excipients and various excipient interaction. The excipient as like of API need to be stabilized and to be standardized along with safety evaluation parameters. These co-excipients have high functionalities as compared to the individual excipients like better flow property, reduced lubricant sensitivity and compressibility.

Keywords: Excipients; Co-Processing; Particle Engineering; Novel Drug Delivery System

Introduction

In recent year scientists have found that a single excipient cannot always provide the requisite performance to allow the certain API to be manufactured or formulated. The co-processed excipients are combination of two or more compendial or non-compendial excipients which are designed to physically modify their properties in manner that are not achievable by simple physical mixing and without a significant chemical change. Development of the co-processed excipients starts with selection of excipients to be combined, preparation method, their targeted proportion to get optimized product with desired physico-chemical parameters and minimizing avoidance with batch to batch variations. Excipient of a reasonable price has to be combined with optimal amount of functional material in order to obtain the integrated product, with a superior functionality than simple mixture of components. The co-processing is interesting because products are physically modified in special way without altering chemical structure. The fixed and homogenous distribution of components is achieved by embedding then within mini granules. Segregation is diminished by the adhesion of actives on the porous particles making process validation and in process reliable and easy control. Co-processed excipient enhances performance of established excipient that possess performance and improvements: in flow, increased surface area, compaction etc [1-3].

Types of Excipients [2,4-6]

Generally, types of excipients are classified into four types enlisted below:

i. Single chemical entity

ii. Physical mixture or blends of excipients

iii. New chemical entities

iv. Co-processed excipients

i. Single chemical entity

The single entity excipient is nothing, but the primary component used as excipient. It may contain other components like:

a. Concomitant component: is a balance between excipient composition and its functionality. These components should be considered as part of composition profile and hence not be construed as being a undesirable, nor confused with presence of added substance [2].

b. Processing Aids: are chemical substances which are used for specific processing need and benefit in excipient manufacturing process, like to improve chemical and physical process ability, to enhance a chemical synthesis reaction, to provide stabilization during the manufacturing process etc. The processing aids can be removed during the excipient manufacturing process or, depending on process clearance capability; it may remain as low level residual in final excipient. [4,5].

c. Additives: It is defined as any substance not normally consumed as a food by itself and one which is intentionally added to food, or for technical purpose in manufacture, processing, preparation or storage of such food to improve their physico-chemical properties. Normally additives are added by simple mixing process and they are incorporated in amount required to produce intended effect. Additives added not be of official grade, it should be of appropriate quality with safety been evaluated for their proposed use. Hence, the additive does not detrimental impact on excipient function and the final drug product safety/efficacy [5].

ii. Physical mixture or blends of excipients

It is a simple physical mixture or blends of two or more excipients to maintain shear processes where, individual components are mixed together without significant change. For solid mixture the individual excipients remain physically separate at particulate level. Excipient blends can be either solid or liquid after simple mixing typically for short duration [3,4].

iii. Novel excipients or new chemical entities

An excipient used for first time in formulation or by a new route of administration is classified as novel or new according to the ICH Guideline. On the other hand, this guideline defines known excipients that are commonly used and well-established usually included in pharmacopoeias and used in registered drug products. When an excipient has not previously been used in a pharmaceutical formulation then there are a number of conditions set out by the US and European regulatory authorities to allow for its use. They are not fully qualified by existing safety data with respect to currently proposed level of exposure, route of administration or duration of exposure [4,5].

iv. Co processed excipients

It is a combination of two or more compendial or noncompendial excipients that are designed to physically modify properties in such manner not achievable by simple physical mixing without significant chemical change. Various methods are available for co-processing like milling, granulation, melt extrusion, spray drying etc. The choice for the specific method/ technique will depend on the material used and desired physical properties to be achieved. Likewise, ratios of the components may vary depending on target performance to attain [2,5].

History

The key objective for co-processing was to achieve a product with additional value associated to the ratio of its functionality and cost. The aspect that occurs during the co-processing method is not understood absolutely but appears to achieve product components in intimate association with each other as single entity. This association cannot be achieved by simple dry blending but requires appropriate co-processing technique.

Primarily, co-processing concept was implemented in food industry to improve stability, dispersibility, gelling properties of food additives. Few co-processed combinations used were Micro crystalline cellulose (MCC) and galactomanan with glucomannan, MCC with Carboxy methyl cellulose (CMC) and sodium alginate complex.

In pharmaceutical industry, the co-processing concept was established in early 1990 with the introduction of co-processed combinations like MCC and calcium carbonate. Cellactose is a co-processed combination of cellulose and lactose, ProSolv is a combination of MCC and colloidal silicon dioxide [7,8].

Excipients Selection Criteria in Co-Processing

The combination of excipient selected for co-processing should compatible and non-reactive to each other. For example, two hexitol group excipient Mannitol: Sorbitol are co-processed to achieve good compressibility as tablet excipient where first is poorly compressible and less hygroscopic and later is good compressible but highly hygroscopic to create balance between plasticity and brittleness. A few other examples of co-processed excipients studied are combination of Lactose: PVP K30: Starch as a ready to use excipient for tablet with diluents, binder and disintegrant property, MCC: Sodium starch glycolate for direct compression immediate release formulations, Dibasic Calcium Phosphate dihydrate co-processed with Pre gelatinised starch for direct compression with binder and diluents property [9-12].

Regulatory Aspects in Co-Processed Excipient

Excipients combinations through co-processing do not produce any chemical modification in the incorporated excipients. Individual properties of excipient are retaining in the combination, the only novelty is the improved functionality with same physical form. Hence, the co-processed combination does not require any toxicological study and can be considered safe if the parent excipients are declared safe by the regulatory agencies GRAS. Very few co-excipients are described in official monograph like Dispersible Cellulose in B.P., Compressible Sugar in U.S.P/NF. Their non-compendial status is the major hurdle in the success of coprocessed excipient in the market. This obstacle will be overcome in the coming future as with New Excipient Safety Evaluation Procedure (NESEP), and excipients now could be reviewed outside the FDA drug approval process. Affirmative opinion from experts of IPEC team will limit the risk of FDA dismissal of drug based on excipient and could encourage innovation in the pharmaceutical industry [13,14].

Current & Future Status of Co-process excipients

At present co-processed excipients have less applicability in the pharmaceutical industry but surely these will be utilized with enhanced functional properties at low concentration in future. Very few new chemical entities are being introduced in market due to stringent rules and regulations by considering safety, efficacy, and cost. Also, very few improvements in existing excipients will help in increased use of co-processed excipients in coming future. Uprising technologies and many more modification are implementing daily in Pharmaceutical industry to achieve high production rate. A growing popularity of high functionality excipients counterpart tablet machine increasing speed capabilities, to modulate the permeability, solubility, or stability of drug, increasing performance expectations related to disintegration, dissolution, bioavailability etc. makes a fantastic opportunity for the development of novel drug delivery system. Forthcoming novel excipient combinations and new co-processing techniques without any doubt going to attract both in research and pharmaceutical industry [15,16].

Fundamental solid-state properties of excipient

The solid-state properties are characterized by three levels as molecular, particle and bulk. These levels are closely linked with each other, reflecting change in one level with another level shown in (Figure 1). The first molecular level is crystal lattice and include phenomenon such as polymorphism, pseudo polymorphism and amorphous state. The second level consist of individual particle size, shape, porosity, and surface area. The third is bulk level comprises of a group of particles and their physical properties. The individual levels depend over each other which provides framework for the development of novel combination of existing and new grade of excipients. The essential solid-state properties of particles like morphology, size, shape, porosity, density, surface area influence excipient functions such as flowability, dilution, lubrication and disintegrating potential, compressibility and Compatability.

The primary characteristic associated with excipient is that no chemical change occur during co-processing and also the reflected changes showed in the physical properties have to prove that coexcipient do not show any chemical change. There should not be covalent bond formation when these individual ingredients are combined to form co-excipient. Also, stereochemical environment, reorientation, bond breaking and the intermolecular forces responsible for new shapes confirms the formation of a new composition. Analytical techniques for characterization used like particle size distribution, specific surface area, SEM images and X-ray diffractogram (XRD) etc. However, the techniques NMR, HPLC, FTIR, DSC, are used in order to aid control their structural properties [17-19].

Methods Of Coprocessing [20-25]

i. Spray Drying.

ii. Solvent Evaporation.

iii. Crystallization.

iv. Melt Extrusion.

v. Granulation/Agglomeration

i. Spray Drying

This technique is applicable for transformation of feed from fluid state into dried particulate form by spraying the feed into the hot drying chamber. It involves continuous drying operation processing. The feed may be in the form of solution or suspension. The dried product can be obtain in powders, granules or agglomerates depending upon it’s physical and chemical properties, dryer design and final powder properties desired. The spray drying combination of ingredient under solid or dry form during drying, by atomizing active compound in suspension or solution form (Figure 2).

ii. Solvent Evaporation

It involves use of liquid as a vehicle to dissolve excipient in organic solvent in which it is immiscible. A core excipient material are also microencapsulated in dissolved or dispersed liquid phase to obtain appropriate size microparticles. The mixture is then heated if necessary, to evaporate the solvent. Once all the solvent gets evaporated, the mixture temperature is reduced to ambient temperature (if required) with continuous agitation. Also, the particles can be used in isolated form as powders or coated sub states. The obtained material can be either water soluble or insoluble depending on material property. After complete drying of obtained mixture is in the form of new single entity co-excipient [26,27].

iii. Crystallization

Crystallization is a solid crystals formation process of precipitating naturally or artificially from the solution and rarely deposited directly from a gas. It is a chemical solid-liquid separation technique, in which mass transfer of solute from the liquid to crystalline solid is obtained and it must be supersaturated. It means that solution has to contain more solute dissolved, unless equilibrium i.e. Supersaturation is achieved. It can be achieved by various methods such as, solution cooling, addition of second solvent to reduce solubility of the solute or by chemical reaction. Change in pH is one of the most common method used in industry for crystallization.

iv. Hot Melt Extrusion

The technique involves mixing of co-processed excipients with meltable binder on a water bath, and then cooling agglomerates to solidify the mass which is subsequently pass through sieve for size reduction. It is a solvent free technique and requires a less processing time. The concentration of selected excipient ratio is a critical variables in the process. The process is a formation of small pellets, beads from the molten mass which is an extruded through extruder. Schematic presentation shown below (Figure 3).

v. Granulation /Agglomeration

The granulation is a process of forming or crystallizing into grains. The granules typically have size range between 0.2 to 4.0mm depending on their use. The Agglomeration is synonymous to granulation process involves particle size enlargement technique to alter product properties. The Agglomeration process is widely used to enhance physical properties like flowability, bulk density, wettability, and product appearance. In pharma industry two types of granulation technologies are employed, mainly dry and wet granulation. Wet granulation is a more preferred method for co-processing (Table 1).

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[nitikapharmaceutical]

 NOVALUBE® – Sodium Stearyl Fumarate (SSF): The Modern Lubricant for High-Performance Formulations

Introducing NOVALUBE® – Advanced Lubrication, Unmatched Performance

In modern pharmaceutical manufacturing, where precision and consistency are key, choosing the right lubricant is critical. NOVALUBE® – Sodium Stearyl Fumarate (SSF) from Nitika Pharmaceutical Specialities Pvt. Ltd. is an innovative, non-hygroscopic, and high-functionality lubricant designed to outperform traditional lubricants like Magnesium Stearate — especially in moisture-sensitive and API-reactive formulations.

As a trusted pharmaceutical excipient supplier, we’ve developed NOVALUBE® to meet the stringent needs of solid oral dosage manufacturers across regulated and semi-regulated markets.

Why NOVALUBE Sodium Stearyl Fumarate?

Sodium Stearyl Fumarate (SSF) is a hydrophilic tablet lubricant that does not interfere with API dissolution. Unlike hydrophobic lubricants, it ensures consistent tablet hardness, faster disintegration, and superior dissolution profiles.

Key Benefits of NOVALUBE® – SSF

✅ Non-Hygroscopic & Stable: Ideal for moisture-sensitive APIs

✅ No Impact on Dissolution: Maintains bioavailability and performance

✅ Consistent Flow & Blend Uniformity: Suitable for high-speed tableting

✅ Regulatory Grade: Meets IP/BP/USP standards

✅ Compatible with Direct Compression & Wet Granulation

Applications in Pharmaceutical Manufacturing

NOVALUBE® is particularly suited for:

High-precision tablets where dissolution speed is critical

Effervescent and chewable tablets

Formulations sensitive to pH, moisture, or frictional heat

Orally disintegrating tablets (ODTs)

It performs exceptionally well in formulations containing enzymes, probiotics, or coated actives, making it an ideal lubricant in complex drug delivery systems.

Why Choose NOVALUBE® from Nitika Pharmaceutical Specialities Pvt. Ltd.?

As a leading Sodium Stearyl Fumarate manufacturer in India, Nitika Pharmaceutical Specialities Pvt. Ltd. ensures:

🌐 Global Compliance – IP/BP/USP/EP

🧪 Batch-to-Batch Consistency with analytical & microbial test reports

📦 Customized Packaging Options for both export and local markets

📄 DMF Support, COA, MOA, Stability Data available

🏭 WHO-GMP, ISO, FSSAI Certified Facility

📩 Interested in samples or bulk inquiries? 📧 enquiry@nitikapharma.com | 🌐 https://nitikapharma.com/ | 📞 +91 7122554812

[nitikapharmaceutical]

How MCC Enhances Tablet Performance and Stability

In modern pharmaceutical manufacturing, a tablet’s performance and stability are as crucial as the efficacy of the active pharmaceutical ingredient (API). While APIs define therapeutic action, excipients ensure the tablet delivers that action effectively. Among the most vital excipients used globally is Microcrystalline Cellulose (MCC).

At Nitika Pharmaceutical Specialities Pvt. Ltd., we understand the critical role MCC plays in ensuring the mechanical strength, disintegration, uniformity, and long-term stability of oral solid dosage forms. This blog explores how MCC functions in pharmaceutical formulations and why Nitika Pharma’s MCC is trusted by pharmaceutical giants across India and international markets.

What is Microcrystalline Cellulose (MCC)?

Microcrystalline Cellulose (MCC) is a purified, partially depolymerized cellulose derived from wood pulp or cotton. It is widely recognized for its role as a binder, filler, and disintegrant in pharmaceutical tablets and capsules.

MCC is odorless, tasteless, and non-reactive with most APIs. It complies with major pharmacopeial standards like USP-NF, Ph.Eur, and JP, making it a globally accepted excipient.

1. MCC as a Powerful Binder for Tablet Integrity

One of the key properties of MCC is its excellent compressibility. It binds powder particles together during compression to form strong, durable tablets. Unlike many synthetic binders, MCC forms robust compacts without needing high compression forces or additional binders.

Benefits:

Produces tablets with high mechanical strength

Reduces the risk of chipping, capping, or breaking

Ensures consistent tablet hardness and friability

Minimizes the use of additional binders

For manufacturers using high-speed rotary tablet presses, MCC’s plastic deformation behavior ensures smoother tableting with fewer defects.

2. Enhancing Tablet Stability and Shelf-Life

Tablets must retain their properties over time, especially when stored under variable environmental conditions. MCC contributes significantly to the chemical and physical stability of formulations.

Key contributions:

Moisture control: MCC is hygroscopic but does not dissolve in water. It buffers water content in the formulation, reducing API degradation.

Inertness: MCC does not react with most APIs, thus preventing drug-excipient interactions.

Thermal stability: Maintains structural integrity even under elevated storage conditions.

At Nitika Pharma, our MCC undergoes rigorous quality control to ensure low residual moisture, controlled particle size, and batch-to-batch consistency, which directly supports shelf stability.

3. MCC Improves Disintegration and Bioavailability

A well-performing tablet must disintegrate quickly in the body to release the API. MCC aids rapid disintegration, especially in orally disintegrating tablets (ODTs) and immediate-release (IR) formulations.

Mechanism:

MCC absorbs water and swells, causing tablets to break apart.

Its capillary action pulls fluid into the matrix, accelerating disintegration.

Uniform dispersion of MCC improves homogeneity and the dissolution profile.

Improved disintegration leads to a faster onset of action, particularly important for analgesics, antipyretics, and cardiovascular drugs.

4. Optimized Flow and Content Uniformity

Poor powder flow is a common bottleneck in tablet production, leading to weight variation and API inconsistency. MCC significantly improves the flowability of granules and powder blends.

Nitika Pharma’s MCC is engineered to deliver:

Consistent particle size and shape

Low cohesion and improved granule flow

Minimal electrostatic charge

Excellent die-fill uniformity in high-speed presses

These properties reduce material segregation, increase blend uniformity, and result in uniform tablet content — a key regulatory requirement.

5. MCC Enables Direct Compression (DC)

Direct compression is the most preferred method of tablet manufacturing due to its cost-effectiveness, fewer steps, and scalability. MCC is one of the few excipients suitable for DC because of:

High bulk density

Cohesive plastic deformation

Lubrication compatibility

Reduced need for granulation

Nitika Pharma’s MCC 101 and MCC 102 grades are optimized for DC applications, offering high flow and excellent compressibility, which is ideal for APIs sensitive to heat or moisture (common in wet granulation).

6. MCC Supports Clean-Label and Natural Formulations

As a naturally derived, non-GMO, and biodegradable excipient, MCC aligns with the increasing demand for clean-label pharmaceutical products.

Pharma companies seeking compliance with regulatory, halal, or kosher standards prefer MCC due to its:

Plant-based origin

Non-toxic nature

Acceptability across global markets

At Nitika Pharma, our MCC is produced under ISO-certified, GMP-compliant, and environmentally responsible facilities, assuring customers of both quality and sustainability.

Applications of MCC in Pharmaceutical Formulations

Formulation MCC Role Direct Compression Tablets Binder, Filler, Disintegrant Capsules Bulk Filler, Flow Aid Chewable Tablets Texture Enhancer Sustained Release Tablets Matrix Former Orally Disintegrating Tablets (ODT)Rapid Disintegration Agent

Why Choose Nitika Pharma for MCC Supply?

As a leading Microcrystalline Cellulose manufacturer in India, Nitika Pharmaceutical Specialities Pvt. Ltd. has earned the trust of pharmaceutical companies across Asia, Europe, Africa, and the Americas.

What Sets Us Apart:

Pharmaceutical-grade MCC with compliance to USP-NF/Ph.Eur/JP

Grades like MCC 101, MCC 102, and custom specifications

State-of-the-art production and testing facilities

Stringent quality control and batch traceability

Technical support for formulation development

Flexible MOQ and export-ready packaging

Whether you’re a generic manufacturer or developing novel formulations, Nitika Pharma’s MCC is engineered to meet the highest industry expectations.

Conclusion

In conclusion, Microcrystalline Cellulose (MCC) plays a multifaceted role in improving tablet performance, manufacturing efficiency, and product stability. From enhancing flow properties and compressibility to supporting fast disintegration and long-term shelf-life, MCC is indispensable to pharmaceutical formulators.

With decades of experience, international certifications, and unwavering quality standards, Nitika Pharmaceutical Specialities Pvt. Ltd. is your reliable partner in supplying MCC that meets the challenges of modern pharmaceutical manufacturing.

Looking for a trusted MCC supplier? Visit www.nitikapharma.com to explore our MCC product range and request a technical datasheet or quotation.