Preparation and evaluation parameters of PCM loaded pellets using Extrusion Spheronization [Experiment Findings]
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The document discusses the preparation and evaluation of paracetamol (PCM) loaded pellets using the extrusion-spheronization method, emphasizing the benefits of controlled drug release. It outlines the required ingredients, equipment, and procedures for creating uniform pellets with excellent physical and flow properties, including size and angle of repose. The findings indicate that the prepared pellets show desirable characteristics for effective pharmaceutical applications.
Preparation and evaluation parameters of PCM loaded pellets using Extrusion Spheronization [Experiment Findings]
- 1. 1 Prepared By: Raj Kumar Mandal B. Pharm ISF College of Pharmacy, Moga Submitted To: Mr. Rahul Pal* Assistant Professor* Department of Pharmaceutics, ISF College of Pharmacy (ISFCP) Moga, GT Road, 142001, Punjab, India Object: Preparation and evaluation parameters of PCM loaded pellets using Extrusion Spheronization. References 1. Xu M, Sun M, Qiao H, Ping Q, Elamin ES. Preparation and evaluation of colon adhesive pellets of 5- aminosalicylic acid. International Journal of Pharmaceutics. 2014 Jul 1;468(1-2):165-71. 2. Pal, Rahul & Mandal, Raj. (2024). ๐๐ซ๐๐ฉ๐๐ซ๐๐ญ๐ข๐จ๐ง ๐๐ง๐ ๐๐ฏ๐๐ฅ๐ฎ๐๐ญ๐ข๐จ๐ง ๐๐๐ซ๐๐ฆ๐๐ญ๐๐ซ๐ฌ ๐จ๐ ๐๐๐ ๐๐๐๐ฅ๐๐ญ๐ฌ (Industrial Pharmacy - I Practical, BP506P ). 10.13140/RG.2.2.32507.32806. 3. Akhgari A, Abbaspour MR, Pirmoradi S. Preparation and evaluation of pellets using acacia and tragacanth by extrusion-spheronization. DARU Journal of Pharmaceutical Sciences. 2011;19(6):417. Requirements โข Chemical Requirements: PCM, MCC, Lactose, Magnesium Stearate, Starch, Distilled water. โข Glassware/Apparatus Requirements: Measuring cylinder, Mortal Pestle, digital weighing balance, extruder spheronizer, air compression/air dryer, funnel, funnel stand, Vernier caliper etc. Theory Pellets are small, spherical or semi-spherical solid dosage forms often used in pharmaceuticals for controlled or sustained release of active ingredients. They are typically uniform in size and offer several benefits, such as improved BA, better control over drug release, and minimized risk of local irritation within the gastrointestinal tract. Pellets can be created using techniques like extrusion-spheronization, layering, and spray drying. Paracetamol (PCM)-Loaded Pellets are pellets that have been formulated with PCM as the active ingredient. These pellets enable precise dosing and can be designed to release PCM in a controlled manner, extending its analgesic and antipyretic effects over time. This formulation can help in managing symptoms more effectively with fewer doses, potentially reducing side effects associated with frequent dosing. PCM -loaded pellets are commonly used in sustained or extended-release formulations to provide consistent pain relief. Experiment Findings
- 2. 2 Procedure Firstly the preparation of PCM Loaded via following these steps in the given Fig. 1 as below. Figure 1: Flow representation of pellets preparations with various parts Preparation of PCM Pellets โข Firstly weight and combine the API with excipients (Table 1) to form a homogeneous powder blend. Gradually add a binder solution or water to the powder blend until a plastic, cohesive wet mass is achieved. โข Load the wet mass into an extruder. The extruder pushes the wet mass through a die plate with circular openings, forming cylindrical extrudates of uniform size. Adjust extrusion speed and die diameter based on desired pellet size. โข Transfer the extrudates to a spheronizer equipped with a rotating plate. The rotating motion and friction with the plate break the extrudates into smaller segments and round them into spherical pellets. The process time and plate speed impact the final pellet shape and size. โข Collect the spherical pellets and dry them using an oven or fluid bed dryer to achieve the desired moisture content and hardness. Drying time and temperature should be optimized to prevent pellet deformation. โข Pass the dried pellets through a sieve to remove oversized or undersized particles, ensuring uniform pellet size. โข Finally PCM pellets obtained and collected as well as evaluated as per the availability. Table 1: List of quantity ingredients involved in the preparation of PCM Loaded Pellets Ingredients Use/Applications Quantity PCM API 2gm MCC Superdisintegrants 14-16 gm Starch Binder 6.5 gm Lactose Diluent/Fillers 2 gm Magnesium Stearate Glidant 3-5 gm The steps involved in the preparation of PCM loaded pellets as per Fig. 2 as below representation.
- 3. 3 Figure 2: Representation of preparation of PCM loaded pellets Evaluations of Prepared PCM Pellets For evaluating prepared pellets of Paracetamol (PCM), the standard procedures to assess physical observation, size, and flow properties: โ Physical Observation: Observe the pellets under a physical visually to check for uniform spherical shape, smooth surface, and absence of cracks or deformations. Examine the color for consistency via necked eyes. โ Determination of Pellets sizes: Using the vernier caliper and place a pellet between the caliper jaws, close the jaws gently without compressing the pellet, and note the reading. Measure each pellet across its largest diameter. The process done with three times and calculate the mean. โ Flow Property (Angle Repose): Measure the angle of repose by pouring pellets through a funnel onto a flat surface and calculating the angle formed with the horizontal. A lower angle of repose indicates better flowability. The evaluation done as per the using apparatus and glassware as per the Fig. 3 as below. Figure 3: Representation of evaluations of prepared PCM Pellets
- 4. 4 Observation and Calculation of PCM Pellets Angle of Repose Sr. No. Diameter Radius Height 1 6.6 3.3 0.3 2 7.2 3.6 0.6 3 7.9 3.8 0.7 ๏ฑ = tan-1 ๐ก ๐ซ The angle obtained after all 3 times calculation as obtained result; Sr. No. Calculated Result of Angle 1 5.1 2 9.1 3 13 Average = ๐.๐+๐.๐+๐๐ ๐ = ๏ป ๐๐ As per Indian Pharmacopeia Standard given in the below tablet the flow property seemed excellent. Sr. No. Flow ability Angle of repose 1 Excellent < 25 2 Good 25-30 3 Moderate flow 30-40 4 Poor flow >40 Pellets Size Determination Sr. No. Measured Pellet Diameter (mm) 1. 3 2. 3 3. 4 Average = ๐+๐.๐+๐.๐ ๐ = ๐๐. ๐/๐ = 3.56 mm Result & Discussion The prepared PCM pellets were successfully formulated and evaluated for various physical and flow properties. The observed milky white color and smooth texture of the pellets suggest good blending and uniformity of ingredients, contributing to the aesthetic appeal and consistency of the formulation. The diameter of 3.56 mm aligns well with the intended pellet size, ensuring the formulation suitability for accurate dosing and potentially controlled release. The low angle of repose (10ยฐ) demonstrates excellent flow properties, likely due to the spherical shape and smooth surface of the pellets, which reduce inter-particle friction. This characteristic is beneficial for manufacturing, as it minimizes flow-related issues like clogging or uneven filling in equipment. The prepared pellets meet quality expectations, with favorable physical characteristics and flowability, supporting their potential effectiveness in pharmaceutical applications.