Typical Physical Attributes of Microcrystalline Cellulose Dried by Spray, Spin Flash and Bulk Drier and Their Resultant Effects on Tablet Properties
ABSTRACT
The solid dosage form is the easiest method of administering drugs for systemic effect. All dosages forms are made by two main components one is API and second is excipient. Excipient is present in bulk quantity and is required for binding the API. There are mainly two techniques uses for manufacturing the tablets (i) wet granulation (ii) direct compression. Wet granulation is a time consuming process, and direct compression technique is time saving, cheap and convenient for pharmaceutical industries. In direct Compression technique, microcrystalline cellulose powder properties are very versatile. There are many processes used for drying of MCC. Out of these, we evaluated MCC with three different type of drying process i.e. Spray dried (SPD), spin flash dried (SFD) and bulk dried. Different drying methods do not change the chemical parameters of microcrystalline cellulose, only difference being the physical attributes of the MCC powder, it’s morphology and it’s consequents flow properties which directly effect the tablet properties i.e. compaction, hardness and in-vitro disintegration among others.
INTRODUCTION
Any pharmaceutical product or formulation is fundamentally composed of two parts: Active Pharmaceutical Ingredient (API) and excipient. API is the substance that has direct effect on the ailment, while excipient is the inert substance that provides stability, bulk, protection to the API, and also improves the bioavailability and helps in increasing the shelf-life of the drug. A number of excipients are used in pharmaceutical industries in the manufacturing of medicament to enhance stability, absorption, flowability. Excipients are inert material and can be natural, semi-synthetic and synthetic in nature 2.
In case of natural excipient they are obtained from different biological resources, for example (i) zoological (lactose, gelatin, stearic acid, honey, lanolin etc.), (ii) botanical and earth element (minerals) (microcrystalline cellulose, starch, mint, glycoproteins, saccharides, silicon dioxide etc.) Semisynthetic excipients are chemically altered from natural excipients, for example hydropropyl methylcellulose (HPMC), eudragit and carboxy methyl ethyl cellulose (CMEC) etc. Synthetic are those excipients which are chemically synthesized from organic compounds, for example boric acid, saccharin, lactic acid, polyethylene glycols etc. 3, 4
Among aforementioned groups, natural excipients are widely used because they have limited traces, ease of availability, and are economically cheap as compared to their synthetic counterparts. Microcrystalline Cellulose (MCC) is one of the most commonly used natural excipient that is obtained from wood pulp 5 . Basically MCC is a polysaccharide biomolecule made up of glucose subunit. Microcrystalline cellulose is one of them. It is used in bulk in pharmaceutical, cosmetic, food and other industries 5.
It is considered as an ideal excipient due to its multiple uses, in pharma industries used as a binder, as filler, as disintegrant, as lubricant, as glident as adsorbent and as anti-adherent, in food industries used as stabilizer, anti-caking agent, emulsifier, stabilizer, texture modifier, suspending and fat substitute agent and in cosmetic industries used as thickener agent, binder fat substitute, stabilize, suspending and anti caking agent 6.
MCC is prepared by hydrolyzing wood pulp with dilute mineral acid. During hydrolysis, the accessible amorphous regions are hydrolyzed and a higher degree of polymerization of wood pulp to lower degree of polymerization microcrystalline cellulose is obtained 7 . It is fine, white color crystalline, granular and free flowing powder.
MCC exhibits a high dilution potential thus broadly used in direct compression formulation 8. In pharmaceutical industries direct compression has progressively gained ground because of being economically advantageous. Direct compression (DC) is only two step process such as mixing and compressing 9. In DC process, with high production
with low cost, the qualities of tablets are outstanding on all parameters. In direct compression technique excipient plays a very important role, it fulfills certain requirements which includes good binding and flow properties,
compatibility with API and other additional excipients 10, 11. Microcrystalline cellulose is used in direct compression due to the extremely good bonding properties as a dry binder 12.
In the present study, microcrystalline cellulose was dried by different methods and evaluated or its physical parameters. Scanning electron microscope was used for studying their morphology. Percentage crystallinity and flowability were tested by using X-ray diffraction and rheometer. Other parameters like hardness, friability, thickness, weight variation and in-vitro disintegration time were also evaluated. The present study is aimed towards comparing morphology, flow properties of microcrystalline cellulose dried by spray, bulk and flash drier and their resultant effects on tablet properties.
MATERIALS:
All three samples manufactured at Sigachi Industries Pvt. Ltd., Spray drier (SPD) HiCel MCC is manufactured in Dahej, Gujarat. Bulk drier AceCel MCC manufactured in Jhagadia, Gujarat. Spin flash drier (SFD) AceCel MCC sample manufactured in Hyderabad
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Source: Sigachi, article “Typical Physical Attributes of MCC”, Tomar et al., IJPSR, 2018; Vol. 9(4): 1545-1554.
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