About Authors:
H.S.Sawwalakhe*, J.M.Maidankar, M.A.Channawar, Dr.A.V. Chandewar
P. W. College of Pharmacy, Yavatmal,
Amravati university
*hemant_11sep@rediffmail.com
ABSTRACT:
The demand for mouth dissolving tablets has been growing during the last decade especially for elderly and children who have swallowing difficulties. Chlorpheniramine maleate is a non-steroidal anti-inflammatory drug (NSAID) histamine H1 antagonist with antihistamine drug it is commonly used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. The main criteria for mouth dissolving tablets are to disintegrate or dissolve rapidly in oral cavity with saliva in 15sec to 60sec with need of water. The disintegrants used should fulfill the criteria by disintegrating the tablets in specified time limit.in the present investigation variety of super disintegrants Crospovidone, sodium starch glycolate,kyron t-314 , were selected and tablets were prepared by direct compression method in different concentration like 3%,6% and 8%. The prepared tablets were evaluated for weight variation, hardness, friability, in vitro disintegration time, wetting time, in vitro dissolution study, etc.formulation f-9 shows the lowest disintegration time (29sec) and wetting time (37sec). In vitro dissolutionstudies revealed that formulation F-9 containning 9% t-314 showed 98% drug release at the end of 10 min.
Reference Id: PHARMATUTOR-ART-1328
INTRODUCTION:
Fast dissolving tablets disintegrate or dissolve in saliva and are swallowed without the need for water. They are beneficial to swallowing tablets and capsules. Thus difficulty is particularly experienced by pediatric and geriatric patients. Various techniques such as freezedrying, sublimation, spray drying, moulding, massextrussion and direct compression method have been reported for preparation of mouth dissolving tablets.
Chlorpheniramine maleate is an effective and selective H1 with anti-histamine and antiallergic properties, used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than promethazine.
MATERIALS AND METHODS:
Chlorpheniramine maleate was received as a gift sample from Astral pharmaceutical,Mumbai.
Indion-204, Kyron-314 were received from Ion exchange india.Ltd, Mumbai & Corel pharma,Ahmadabad respectively.Crosspovidone & Sodium starch glycolate were purchased from Maple Biotech Pvt .Ltd. Pune.Lactose was obtained from Loba chemicals Pvt. Ltd. Mumbai.Mannitol, Aspartame were purchased from Cipla Pvt. Ltd. Mumbai.Talc, Magnesium Stearate were obtained from S. D. Fine Chemicals, Mumbai.All other chemicals and solvents used were of analytical grade.
PREPARATION OF MIXED BLEND OF DRUG AND EXCIPIENTS:
All the materials were passed through sieve no. 60. Required quantity of each ingredient was taken for each specified formulation (Mentioned in Table no. 1) and all the ingredients were subjected to grinding to a required degree of fineness (except magnesium stearate). The powdered blend was evaluated for flow properties as follows.
Evaluation of powder blend:
1) Angle of repose:6
Angle of repose was determined using fixed funnel method. The blend was poured through a funnel that can be raised vertically until a maximum cone height (h) was obtained. Radius of the heap (r) was measured and the angle of repose (?) was calculated using the formula. θ = tan -1 (h / r)
2) Bulk density:6
Bulk density was determined by pouring the blend into a graduated cylinder. The bulk volume (V) and weight of the powder (M) was determined. The bulk density was calculated by using the below mentioned formula,
Mass of granules
Bulk density = -------------------------
Volume of granules
3) Tapped density:6
The measuring cylinder containing a known mass of blend was tapped for a fixed time. The minimum volume (Vt) occupied in the cylinder and the weight (M) of the blend was measured. The tapped density was calculated using the following formula,
Weight of the blend
Tapped density = ---------------------------------
Volume occupied in the cylinder (Vt)
4) Compressibility index:7
The simplest way for measurement of free flow of powder is compressibility , a indication of the ease with which a material can be induced to flow is given by compressibility index (I) which is calculated as follows,
Vo - Vt
I = -----------------
Vbx
Here, Vo is bulk volume and Vt is tapped volume. The value below 15% indicates a powder with usually give rise to good flow characteristics, whereas above 25% indicate poor flowability.
5) Hausner’s Ratio:7
Hausner’s ratio is an indirect index of ease of powder flow. It is calculated by the following formula,
Tapped density
Hausner ratio = -----------------------
Bulk density
Lower Hausner’s ratio (<1.25) indicates better flow properties than higher ones (>1.25).
Compression of tablets by using direct compression technique:8,9
Finally magnesium stearate was added to prepared blend. The mixed blend of drug and excipients was compressed using a single punch tablet punching machine at 30 PCI to produce concave faced tablets, weighing 150 mg each with a diameter of 8 mm. A minimum of 20 tablets were prepared for each batch.
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