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Research and

Development Umme

Sadia Jaynob

GM, Product Development

Generic brand product development

In its own laboratory, the Radiant Product Development Team creates pharmaceutical-grade
generic brands in four departments: formulation, analysis, packaging, and validation. All of
these departments are well-equipped and are operated by a team of individuals with years of
expertise in the development of pharmaceutical products, strong work ethics, innovative
ideas, a strong work ethic, mutual respect, a background in chemistry and pharmacy, and a
dedication to producing high-quality products on schedule.

Product development entails designing a high-quality product and developing manufacturing procedures
to ensure the consistent production of the necessary quality product. All of the processes and
requirements associated with product development are described in the documentation. Reviewers and
inspectors can learn about the product and manufacturing processes from the documentation protocol.
The risks of misinterpretation and potential errors that may arise during the product development
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process are controlled minimized by documentation.

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 New Product Development Process:
 Firstly, market requirement of a product is analyzed and the requirement for the new product is
informed to R&D department.
 Then pre-formulation studies are done to access the physical properties of the product.
 Innovator/reference listed drug products (RLD) is used as a reference product to carry out drug
assay.
 Drug properties are studied to determine which process will be suitable to develop the drug. Such
as heat sensitivity, hygroscopicity these properties are considered.
 Suitable excipients are chosen which are compatible which the API.
 Chemical trail is done and after the drug passes the chemical trail stability study begins.
 After stability studies packaging material and process are determined. API sensitivity determines
drug packaging.
 Three validation batches are run in both accelerated and long-term conditions.
 Approval from regulatory body is taken. All the necessary information related to the drug such as
general introduction to the medicine, including its pharmacological class, mode of action, and
proposed clinical use must be submitted for regulatory body approval.
 Process Validation; to validate the process from R&D scale to commercial scale.
 Finally, a report is submitted.

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Product Development Challenges
 Ideation

 Market availability

 Product road map problems

 Work flow management

 Product engineering issues

 Pricing policy

 Time-to-market

 During formulation PD has to undertake intensive research. Literatures have to be

searched for-

 Stability assay, key solubility data.

 Bulk properties, solubility and stability profile and compatibility.

Lab Batch:
A lab batch is created to verify the efficacy of the formulation. The DRA receives the
recipe. Additionally, an analysis of feasibility is conducted. Several modifications are
made to the lab batch recipe.

Pilot Batch:
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 The manufacturing procedure should be validated on at least three pilot lots to
identify the critical parameters in the product and process. Tentative limits
fixed for the critical variables may be modified from the data available by
stability studies.

Stability Study:

There are two methods by which stability is tested: Real-time stability study, and
Accelerated stability study.

 Products are kept in the stability chamber at three different conditions:

 Real time stability: 25°C, 60% Relative Humidity (RH) for sensitive products &

30 ±2 °C, 65% RH, it is checked after 6 months, 12 months, 24 months, and 36 months.

 Accelerated stability: 40°C, 75% RH, and it is checked after 3 months and 6 months.

The product stays in the stability chamber for 6months. If the degradation of the product
is less than 5% in 6 months, then the shelf life is 2years.

The Analytical method development requires demonstration of suitable-

 Accuracy

 System Suitability

 Precision

 Specificity

 Range

 Robustness

 Sensitivity

 Ruggedness

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  Stability parameters are-

 Physical parameters

 Chemical parameters

 Microbiological parameters

 Therapeutically parameters

 Toxicological parameters.

Machines Observed in R&D Department

Name of Instrument Company Origin Uses

HPLC Shimadzu Japan Analytical Test:

Identification
Qualification
Separation
Fluid bed process Shimadzu Japan Helps in attaining the
granulation, coating and
drying of a product so
that uniform coating
and drying is ensured
Super mixer granulator Inora Taiwan Used in mixing granules
up to 2-5 kgs
Super coater Inora Taiwan Used for film coating
tablet

Atomic Absorption Shimadzu Japan Used to detect metals

like zinc, copper,
spectrophotometer AA-700
calcium, iron,
potassium in ppm level
ICP OES Malver Japan Detects trace metals like
manganese, lead,
mercury, arsenic in ppb
level
Particle size analyzer Malver USA Determine the average
particle size of raw
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 material
HPLC Waters USA Analytical Test:
Identification
Qualification
Separation
Differential Scanning Shimadzu Japan Determines drug-
Calorimeter-60 Plus excipient compatibility

Muffle Furnace Nabertherm Germany The isolation of a

material to reduce the
risks of cross-
contamination and
identify specific
properties.
Vaccum Oven Scientech India Determines loss on
drying, drying heat
sensitive materials, and
used as a vaccum at
60°C
Sieve Shaker Electro Lab India Facilitating accurate
particle separation

Tap density Tester Electro Lab India To measure the tapped

density of bulk powders
and granulated particles
X-ray Powder Diffractor Bruker D8 USA Determines the drug-
Advanced excipient compatibility
by measuring the angle
of diffraction, detects
unknown compound.

For checking the physical parameters of the tablet there were the following
machineries present in the R&D Department
 UV- Viewing Cabin

 Melting Point Apparatus

 Halogen Moisture Apparatus

 Roman Imaging Microscope

 Viscometer

 Hardness Tester

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  Refractometer

 Polarimeter

In R&D wet lab the following equipment were present:

 Analytical balance

 Disintegration tester

 pH meter

 Conductivity meter

 Digital water bath

 Digital shaker

 Ultrasonic bath

 Centrifuge machine

 Dissolution tester

 Fume hood

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